← Product Code [DHB](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHB) · K242531

# NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay Analyz (K242531)

_Hycor Biomedical · DHB · Apr 23, 2025 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHB/K242531

## Device Facts

- **Applicant:** Hycor Biomedical
- **Product Code:** [DHB](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHB.md)
- **Decision Date:** Apr 23, 2025
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5750
- **Device Class:** Class 2
- **Review Panel:** Immunology

## Intended Use

The NOVEOS Specific IgE Assay is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum. NOVEOS Specific IgE Assay is to be used with the NOVEOS Immunoassay Analyzer. It is intended for use as an in vitro diagnostic aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings and is to be used in clinical laboratories.

## Device Story

The NOVEOS Specific IgE Assay is an in vitro diagnostic test used on the NOVEOS Immunoassay Analyzer to quantify allergen-specific IgE in human serum. The assay uses fluorescent-labeled, streptavidin-coated magnetic microparticles incubated with biotinylated allergenic capture reagents, patient serum, and HRP-labeled anti-human IgE monoclonal antibody. A magnetic field collects the beads, and wash steps remove unbound components. A chemiluminescent substrate is added; light generation is proportional to the amount of antibody-conjugate complex bound to the beads. Fluorescence corrects for bead loss. The instrument compares the corrected chemiluminescence to a calibration curve traceable to WHO standard 11/234. Results are used by clinicians to diagnose IgE-mediated allergic disorders. The device is intended for use in clinical laboratories.

## Clinical Evidence

Clinical performance was evaluated by comparing test results from atopic (confirmed by skin prick test or food challenge) and non-atopic (confirmed negative by ImmunoCAP) cohorts. Sensitivity ranged from 50.0% to 76.1% and specificity from 93.6% to 100.0% across the eight allergens. Literature citations were provided to support observed sensitivity levels for specific allergens (T003, F001, F002).

## Technological Characteristics

Immunometric, chemiluminescent assay using fluorescent-labeled magnetic, streptavidin-coated microparticles. Energy source: NOVEOS Immunoassay Analyzer. Calibration: 6-level curve traceable to WHO reference reagent 11/234. Reaction temperature: 37°C. Connectivity: Automated analyzer system. Software: Version 1.1.0, Moderate level of concern. Sterilization: Not applicable (reagents).

## Regulatory Identification

A radioallergosorbent immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the allergen antibodies (antibodies which cause an allergic reaction) specific for a given allergen. Measurement of specific allergen antibodies may aid in the diagnosis of asthma, allergies, and other pulmonary disorders.

## Special Controls

*Classification.* Class II (special controls). The device, when intended to detect any of the allergens included in Table 1 in this paragraph, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.    Table 1—Class II Exempt Allergens Under § 866.5750—Radioallergosorbent (RAST) Immunological Test Systems
  Allergen code Allergen product Source  (taxonomical name)   Grass Pollens  g1 Sweet vernal grass  Anthoxanthum odoratum.  g3 Cocksfoot grass, Orchard grass  Dactylis glomerata.  g4 Meadow fescue  Festuca elatior.  g5 Rye-grass (perennial rye grass)  Lolium perenne.  g7 Common reed (common reed grass)  Phragmites communis.  g8 Meadow grass, Kentucky blue (June grass)  Poa pratensis.  g9 Redtop, Bentgrass  Agrostis stolonifera ,Agrostis gigantea (Agrostis alba ). g11 Brome grass  Bromus inermis.  g12 Cultivated rye (cultivated rye grass)  Secale cereale.  g13 Velvet grass  Holcus lanatus.  g14 Cultivated oat (cultivated oat grass)  Avena sativa.  g15 Cultivated wheat (cultivated wheat grass)  Triticum aestivum (Triticum spp.). g16 Meadow foxtail (meadow foxtail grass)  Alopecurus pratensis.  g17 Bahia grass  Paspalum notatum.  g24 Wheat grass, Western  Agropyron smithii (Elymus smithii ). g30 Bluegrass, annual  Poa annua.  g70 Wild rye grass  Elymus triticoides Elymus condensatus.  g71 Canary grass  Phalaris arundinacea.  g201 Barley, cultivated  Hordeum vulgare.  g202 Maize, corn (cultivated corn)  Zea mays.  g203 Salt grass  Distichlis spicata.  g204 False oat-grass  Arrhenatherum elatius.  g216 Cyn d 1  Cynodon dactylon.  g701 Phl p 1.0102, Phl p 5.0101  Phleum pratense.  g702 Phl p 7.0101  Phleum pratense.  g703 Phl p 12.0101  Phleum pratense.   Weed Pollens  w2 Western ragweed  Ambrosia psilostachya.  w4 False ragweed  Ambrosia acanthicarpa (Franseria acanthicarpa ). w5 Wormwood  Artemisia absinthium Artemisia annua.  w6 Mugwort  Artemisia vulgaris.  w7 Marguerite, ox-eye daisy  Chrysanthemum leucanthemum.  w8 Dandelion  Taraxacum vulgare ,Taraxacum officinale.  w9 Plantain (English), Ribwort  Plantago lanceolata.  w10 Goosefoot, lamb's quarters  Chenopodium album.  w11 Saltwort (prickly), Russian thistle  Salsola kali (Salsola pestifer ). w12 Goldenrod  Solidago virgaurea (Solidago spp.). w13 Cocklebur, common  Xanthium commune.  w14 Common pigweed (rough pigweed)  Amaranthus retroflexus.  w15 Scale, Lenscale  Atriplex lentiformis.  w16 Rough marsh elder  Iva ciliate ,Iva annua.  w17 Firebush (Kochia)  Kochia scoparia.  w18 Sheep sorrel  Rumex acetosella.  w19 Wall pellitory  Parietaria officinalis.  w20 Nettle (Common stinging nettle)  Urtica dioica.  w21 Wall pellitory  Parietaria judaica.  w22 Japanese hop (careless weed)  Humulus japonicas (Humulus scandens ). w23 Yellow dock, Yellow dockweed  Rumex crispus.  w24 Spiny pigweed  Amaranthus spinosus.  w27 Carnation  Dianthus spp. w28 Rose  Rosa rugosa.  w33 Clover  Trifolium pratense.  w35 Mexican tea  Chenopodium ambrosioides.  w36 Rabbit bush  Ambrosia deltoidea (Franseria deltoides ). w37 Salt bush, annual  Atriplex wrightii.  w39 Water hemp, Western  Amaranthus rudis (Acnida tamariscina ). w41 Burrobrush  Hymenoclea salsola.  w42 Poverty weed  Baccharis neglecta.  w43 Common sagebrush  Artemisia tridentata.  w45 Alfalfa  Medicago sativa.  w46 Dog fennel  Eupatorium capillifolium.  w53 Geranium  Geranium spp. w67 Groundsel bush  Baccharis halimifolia.  w69 Iodine bush  Allenrolfea occidentalis.  w70 Ragweed, slender  Ambrosia confertiflora.  w75 Wing scale (wingscale)  Atriplex canescens.  w82 Careless weed  Amaranthus palmeri ,Amaranthus hybridus.  w90 Japanese hop  Humulus japonicas (Humulus scandens ). w203 Rape (rape pollen)  Brassica napus.  w204 Sunflower  Helianthus annuus.  w206 Camomile  Matricaria chamomilla.  w207 Lupin  Lupinus spp. w210 Sugar-beet  Beta vulgaris.  w211 Par j 2.0101  Parietaria judaica.  w231 Art v 1  Artemisia vulgaris (Mugwort). w232 Sal k 1  Salsola kali.  w233 Art v 3  Artemisa vulgaris (LTP, Mugwort). w234 Pla l 1  Plantago lanceolata.  w235 Che a 1.0101  Chenopodium album.  w236 Mer a 1.0101  Mercurialis annua.  a753 Art v 1  Artemisia vulgaris (Mugwort weed).  Tree Pollens  t1 Box-elder (Maple)  Acer negundo ,Acer saccharum.  t2 Gray alder, speckled alder (alder)  Alnus incana.  t4 Hazel, hazelnut  Corylus avellana ,Corylus americana.  t5 American beech (beech)  Fagus grandifolia (Fagus americana ). t6 Mountain juniper, Mountain cedar  Juniperus ashei (Juniperus sabinoides ). t8 Elm  Ulmus americana.  t9 Olive  Olea europaea.  t10 Walnut  Juglans californica ,Juglans nigra.  t11 Maple leaf sycamore, London plane, Plane tree  Platanus acerifolia.  t61 Sycamore  Platanus occidentalis.  t12 Willow  Salix caprea ,Salix nigra.  t14 Cottonwood (Eastern Cottonwood/Black Cottonwood)  Populus deltoides.  t15 White ash  Fraxinus americana.  t16 White pine  Pinus strobus.  t18 Eucalyptus, gum-tree  Eucalyptus globulus (Eucalyptus spp.). t19/t26 Acacia  Acacia longifolia (Acacia spp.). t20 Mesquite  Prosopis glandulosa/ Prosopis juliflora.  t21 Melaleuca, cajeput tree  Melaleuca quinquenervia (Melaleuca leucadendron ). t22 Pecan, hickory  Carya illinoinensis (Carya pecan ). t23 Italian/Mediterranean/funeral cypress  Cupressus sempervirens.  t24 Japanese cypress  Chamaecyparis obtusa (Chamaecyparis spp.). t25 Ash  Fraxinus excelsior.  t27 Maple, red  Acer rubrum.  t29 Acacia  Acacia spp. t30 Birch, white  Betula populifolia.  t32 Willow, black  Salix nigra.  t33 Ash, Arizona  Fraxinus velutina.  t35 Cedar, salt  Tamarix gallica.  t37 Bald cypress (white bald cypress)  Taxodium distichum.  t38 Elm, Chinese/Siberian  Ulmus pumila.  t40 Hazelnut tree  Corylus americana.  t41 White hickory  Carya alba (Carya tomentosa ). t42 Oak, red  Quercus rubra.  t43 Loblolly pine  Pinus taeda.  t44 Hackberry  Celtis occidentalis.  t45 Cedar elm  Ulmus crassifolia.  t47 Juniper, one seed  Juniperus monosperma.  t48 Pine, lodgepole  Pinus contorta.  t49 Pine, ponderosa  Pinus ponderosa.  t50 Beech, European  Fagus sylvatica.  t51 Tree of Heaven  Ailanthus altissima.  t52 Western white pine  Pinus monticola.  t54 Russian olive  Elaeagnus angustifolia.  t55 Scotch broom  Cytisus scoparius.  t56 Bayberry  Myrica cerifera.  t57 Red cedar  Juniperus virginiana.  t60 Western juniper  Juniperus occidentalis.  t61 Sycamore  Platanus occidentalis.  t70 Mulberry (white mulberry)  Morus alba.  t71 Red mulberry  Morus rubra.  t72 Queen palm  Arecastrum romanzoffiamon.  t73 Australian pine  Casuarina equisetifolia.  t77 Oak mix (red, white, black)  Quercus spp. t80 Japanese cypress  Chamaecyparis obtusa.  t81 Japanese alder  Alnus japonica.  t83 Mango tree  Mangifera indica.  t90 Walnut, black  Juglans nigra.  t96 Poplar, white (poplar)  Populus alba.  t103/t218 Virginia live oak (live oak)  Quercus virginiana.  t105 Pepper tree  Schinus molle.  t110 Orange tree  Citrus sinensis.  t201 Spruce, Norway spruce  Picea abies (Picea excelsa ). t202 Alder, smooth  Alnus incana spp.Rugosa (Alnus rugosa ). t203 Horse chestnut  Aesculus hippocastanum.  t205 Elder  Sambucus nigra.  t206 Chestnut  Castanea sativa.  t207 Douglas fir  Pseudotsuga menziesii (Pseudotsuga taxifolia ). t208 Linden  Tilia cordata.  t209 Horn beam  Carpinus betulus.  t210 Privet  Ligustrum vulgare.  t211 Sweet gum  Liquidambar styraciflua.  t212 Cedar  Libocedrus decurrens.  t213 Pine  Pinus radiata.  t214 Date palm  Phoenix canariensis.  t215 Lilac  Syringa vulgaris.  t217 Pepper tree  Schinus molle.  t217 Red alder  Alnus rubra.  t218 Virginia live oak  Quercus virginiana.  t218 Bayberry (bayberry/sweet gale)  Myrica gale.  t219 Palo verde  Cercidium floridum.  t219 Red cedar  Juniperus virginiana.  t220 Bet v 4  Betula verrucosa (Birch). t221 Bet v 2.0101, Bet v 4  Betula verrucosa (Birch). t222 Cypress (Arizona cypress)  Cupressus arizonica.  t223 Oil palm  Elaeis guineensis.  t224 Ole e 1  Olea europaea.  t225 Bet v 6  Betula verrucosa (Birch). t226 Cup a 1  Cupressus arizonica.  t227 Ole e 7  Olea Europaea.  t228 Aspen, quaking  Populus tremuloides.  t229 Eastern hemlock  Tsuga canadensis.  t230 Redwood (sequoia)  Sequoia sempervirens.  t232 Pussy willow  Salix discolor.  t240 Ole e 9.0101  Olea Europaea.  t241 Pla a 1.0101  Platanus acerifolia.  t242 Pla a 2  Platanus acerifolia.  t243 Pla a 3.0101  Platanus acerifolia.  t244 Cor a 1.0103  Corylus avellana.  t245 Aln g 1.0101  Alnus glutinosa.  t246 Cry j 1  Cryptomeria japonica.  t280 Locust tree  Robinia pseudoacacia.  t401 Brazilian peppertree  Schinus terebinthifolius.  t402 Mastic tree  Pistacia lentiscus.  t404 Tree of heaven  Ailanthus altissima.  t406 Date palm  Phoenix dactylifera.  a482 Ole e 1  Olea europaea (Olive Oil).  Mites  d207 Blo t 5.0101  Blomia tropicalis.  d208 Lep d 2.0101  Lepidoglyphus destructor.   Microorganisms, Molds, Yeast  m1  Penicillium chrysogenum (Penicillium notatum ) Penicillium chrysogenum (Penicillium notatum ). m2  Cladosporium herbarum (Hormodendrum ) Cladosporium herbarum (Hormodendrum ). m3  Aspergillus fumigatus  Aspergillus fumigatus.  m4  Mucor racemosus  Mucor racemosus.  m5  Candida albicans  Candida albicans.  m7  Botrytis cinerea  Botrytis cinerea.  m8  Drechslera halodes (Setomelanomma rostrata, Helminthosporium halodes, Helminthosporium interseminatum ) Drechslera halodes (Setomelanomma rostrata, Helminthosporium halodes.  m9  Fusarium moniliforme (Fusarium proliferatum ) Fusarium moniliforme (Fusarium proliferatum ). m10  Stemphylium botryosum  Stemphylium herbarum (Stemphylium botryosum ). m11  Rhizopus nigricans  Rhizopus nigricans.  m12  Aureobasidium pullulans  Aureobasidium pullulans.  m13  Phoma betae  Phoma betae.  m14  Epicoccum purpurascens  Epicoccum purpurascens (Epicoccum nigrum ). m15  Trichoderma viride  Trichoderma viride.  m16  Curvularia lunata  Curvularia lunata ,Curvularia specifera (K923044 ). m17  Cladosporium fulvum  Cladosporium fulvum.  m18  Fusarium culmorum  Fusarium culmorum.  m19  Aspergillus versicolor  Aspergillus versicolor.  m20  Mucor mucedo  Mucor mucedo.  m21  Aspergillus clavatus  Aspergillus clavatus.  m22  Micropolyspora faeni  Saccharopolyspora rectivirgula (Micropolyspora faeni ). m23  Thermoactinomyces vulgaris  Thermoactinomyces vulgaris.  m24  Stachybotrys atra  Stachybotrys chartarum (Stachybotrys atra ). m24  Paecilomyces spp Paecilomyces spp. m25  Aspergillus versicolor  Aspergillus versicolor.  m25  Penicillium brevicompactum  Penicillium brevicompactum.  m26  Cladosporium cladosporioides  Cladosporium cladosporioides.  m26  Penicillium citrinum  Penicillium citrinum.  m27  Penicillium spp Penicillium spp. m29  Aspergillus repens  Aspergillus repens.  m30  Penicillium roqueforti  Penicillium roqueforti.  m32  Cladosporium cladosporioides  Cladosporium cladosporioides.  m34  Serpula lacrymans  Serpula lacrymans.  m36  Aspergillus terreus  Aspergillus terreus.  m37  Trichophyton mentagrophytes  Trichophyton mentagrophytes.  m40  Aspergillus amstelodami  Aspergillus amstelodami.  m43  Saccharomyces Carlsberg  Saccharomyces carlsbergensis.  m44  Saccharomyces cerevisiae  Saccharomyces cerevisiae.  m45  Hormodendrum hordei  Hormodendrum hordei.  m46  Bipolaris spicifera  Bipolaris spicifera.  m47  Aspergillus nidulans  Aspergillus nidulans.  m48  Aspergillus oryzae  Aspergillus oryzae.  m49  Fusarium oxysporum  Fusarium oxysporum.  m50  Micropolyspora faeni  Saccharopolyspora rectivirgula (Micropolyspora faeni ). m51  Thermoactinomyces vulgaris  Thermoactinomyces vulgaris.  m53  Microspora canis  Microsporum canis (Microspora canis ). m54  Aspergillus flavus  Aspergillus flavus.  m63  Helminthosporium intersemin  Helminthosporium intersemin.  m66  Mucor plumbeus  Mucor plumbeus.  m67  Mycogone  Mycogone perniciosa.  m68  Nigrospora oryzae  Nigrospora oryzae.  m69  Rhodotorula  Rhodotorula rubra (Rhodotorula mucilaginosa ). m70  Malassezia furfur (Pityrosporum orbiculare ) Malassezia furfur (Pityrosporum orbiculare ). m71  Spondylocladium  Spondylocladium spp. m72  Epidermophyton  Epidermophyton floccosum.  m73  Epicoccum nigrum  Epicoccum purpurascens (Epicoccum nigrum ). m80  Staphylococcal enterotoxin A (Sta a SEA ) Staphylococcus aureus.  m80  Helminthosporium spp Helminthosporium spp. m81  Staphylococcal enterotoxin B (Sta a SEB ) Staphylococcus aureus.  m88  Stemphylium solani  Stemphylium solani.  m93  Gliocladium fimbriatum  Gliocladium fimbriatum.  m94  Phycomyces blakesleeanus  Phycomyces blakesleeanus.  m201  Tilletia tritici (Ustilago nuda, Ustilago tritici ) (Barley smut) Tilletia tritici (Ustilago nuda, Ustilago tritici ). m202  Acremonium kiliense (Cephalosporium acremonium ) Acremonium kiliense (Cephalosporium acremonium ). m203  Trichosporon pullulans  Trichosporon pullulans.  m204  Ulocladium chartarum  Ulocladium chartarum.  m205  Trichophyton rubrum  Trichophyton rubrum.  m207  Aspergillus niger  Aspergillus niger.  m208  Chaetomium globosum  Chaetomium globosum.  m209  Penicillium frequentans  Penicillium glabrum (Penicillium frequentans ). m209  Stachybotrys chartarum  Stachybotrys chartarum (Stachybotrys atra ). m210  Trichophyton mentagrophytes var. goetzii  Trichophyton mentagrophytes var. goetzii.  m211  Trichophyton mentagrophytes var. interdigitale  Trichophyton mentagrophytes var. interdigitale.  m211 Oat smut  Ustilago avenae.  m212  Micropolyspora faeni  Saccharopolyspora rectivirgula (Micropolyspora faeni ). m212  Geotrichum candidum  Geotrichum candidum.  m213 Bermuda grass smut  Ustilago cynodontis.  m214 Johnson grass smut  Sphacelotheca cruenta.  m215 Corn smut  Ustilago maydis.  m218 Asp f 1.0101  Aspergillus fumigatus.  a3050 Asp r 1  Aspergillus restrictus.  m219 Asp f 2  Aspergillus fumigatus.  m220 Asp f 3.0101  Aspergillus fumigatus.  m221 Asp f 4  Aspergillus fumigatus.  m222 Asp f 6.0101  Aspergillus fumigatus.  m223  Staphylococcal enterotoxin C (Sta a SEC ) Staphylococcus aureus.  m224  Staphylococcal enterotoxin D (Sta a SED ) Staphylococcus aureus.  m226  Staphylococcal enterotoxin TSST (Sta a TSST ) Staphylococcus aureus.  m227  Malassezia spp. (Pityrosporum spp.) Malassezia spp. (Pityrosporum spp.). m228  Aspergillus flavus.   m229 Alt a 1.0101  Alternaria alternata (Alternaria tenuis ). m230 Alt a 6.0101  Alternaria alternata (Alternaria tenuis ). m231 Cla h 8.0101  Cladosporium herbarum (Hormodendrum ). m300  Eurotium spp Eurotium spp. m304  Aspergillus oryzae  Aspergillus oryzae.  m305  Penicillium brevicompactum  Penicillium brevicompactum.  m309  Aspergillus terreus  Aspergillus terreus.  m310  Aspergillus nidulans  Aspergillus nidulans.  m311  Aspergillus flavus  Aspergillus flavus.  m312  Aspergillus clavatus  Aspergillus clavatus.   Epidermal & Animal  e6 Guinea pig epithelium  Cavia porcellus.  e7 Pigeon droppings  Columba palumbus ,Columba livia.  e25 Chicken serum  Gallus domesticus (Gallus gallus domesticus; Gallus spp.). e26 Parrot serum  Psittacoidea spp. e62 Camel  Camelus dromedaries.  e70 Goose feathers  Anser anser.  e71 Mouse epithelium  Mus musculus (Mus spp.). e73 Rat epithelium  Rattus norvegicus.  e74 Rat urine proteins  Rattus norvegicus ,Rattus rattus.  e75 Rat serum proteins  Rattus norvegicus ,Rattus rattus.  e76 Mouse serum proteins  Mus musculus (Mus spp.). e77 Budgerigar droppings  Melopsittacus undulatus.  e78 Budgerigar feathers  Melopsittacus undulatus.  e79 Budgerigar serum proteins  Melopsittacus undulatus.  e80 Goat epithelium  Capra hircus.  e81 Sheep epithelium  Ovis aries (Ovis spp.). e82 Rabbit epithelium  Oryctolagus cuniculus (Oryctolagus spp.). e83 Swine epithelium  Sus scrofa (Sus scrofa domesticus; Sus spp.). e84 Hamster epithelium  Cricetus cricetus, Mesocricetus auratus, and Phodopus sungorus.  e85 Chicken feathers  Gallus domesticus (Gallus gallus domesticus; Gallus spp.). e86 Duck feathers  Anas platyrhynchos.  e87 Rat epithelium, serum proteins, and urine proteins  Rattus norvegicus Rattus rattus.  e88 Mouse epithelium, serum proteins, and urine proteins (mouse)  Mus musculus (Mus spp.). e89 Turkey feathers  Meleagris gallopavo.  e90 Budgerigar serum proteins, feathers, and droppings  Melopsittacus undulatus.  e91 Pigeon serum proteins, feathers, and droppings  Streptopelia roseogrisea ,Psittacidae spp. e92 Parrot serum proteins, feathers, and droppings  Ara spp. e93 Pigeon serum proteins  Streptopelia roseogrisea.  e94 Fel d 1.0101  Felis domesticus.  a345 Fel d 1  Felis domesticus.  e98 Parrot droppings  Psittacoidea spp. e101 Can f 1.0101  Canis familiaris (Canis domesticus ). a174 Can f 1  Canis familiaris (Canis domesticus ). e102 Can f 2.0101  Canis familiaris (Canis domesticus ). e196 Parakeet feathers  Nymphicus hollandicus.  e197 Parakeet droppings  Nymphicus hollandicus.  e198 Parakeet serum  Nymphicus hollandicus.  e199 Canary bird serum  Serinus canarius.  e200 Canary bird droppings  Serinus canarius.  e201 Canary bird feathers (Canary feathers)  Serinus canarius.  e202 Reindeer epithelium  Rangifer tarandus.  e203 Mink epithelium  Mustela spp. e204 Bos d 6  Bos domesticus (Bos taurus; Bos spp.). e205 Horse, serum proteins  Equus caballus (Equus spp.). e206 Rabbit, serum proteins  Oryctolagus cuniculus (Oryctolagus spp.). e208 Chinchilla epithelium  Chinchilla laniger.  e209 Gerbil epithelium  Meriones unguiculatus.  e210 Fox epithelium  Vulpes vulpes.  e211 Rabbit, urine proteins  Oryctolagus cuniculus (Oryctolagus spp.). e212 Swine, urine proteins  Sus scrofa (Sus scrofa domesticus; Sus spp.). e213 Parrot feathers  Ara spp. e214 Finch feathers  Lonchura domestica.  e215 Pigeon feathers  Streptopelia roseogrisea (Streptopelia spp.),Columbia spp. e216 Deer epithelium  Dama dama.  e217 Ferret epithelium  Mustela putorius.  e218 Chicken droppings  Gallus domesticus (Gallus gallus domesticus; Gallus spp.). e219 Chicken, serum proteins  Gallus domesticus (Gallus gallus domesticus; Gallus spp.). e220 Fel d 2, Cat serum albumin  Felis domesticus.  e221 Can f 3  Canis familiaris (Canis domesticus ) (Dog serum albumin ). e222 Swine serum albumin (Sus s PSA)  Sus scrofa (Sus scrofa domesticus; Sus spp.). e225 Lovebird feathers  Psittacoidea agapomis.  e226 Can f 5.0101  Canis familiaris.  e227 Equ c 1.0101  Equus caballus.  e228 Fel d 4.0101  Felis domesticus.  e230 Equ c 3  Equus caballus.  e231 Mus m 1  Mus musculus.   Food  f9 Rice  Oryza sativa.  f12 Pea (green pea)  Pisum sativum.  f15 White bean  Phaseolus vulgaris.  f19 Cayenne pepper  Capsicum frutescens (Capsicum annum ). f21 Sugar cane  Saccharum officinarum.  f22 Raspberry  Rubus idaeus.  f26 Pork  Sus scrofa (Sus scrofa domesticus; Sus spp.). f29 Watermelon  Citrullus lanatus (Citrullus vulgaris ). f31 Carrot  Daucus carota.  f32 Oyster mushroom  Pleurotus ostreatus.  f33 Orange  Citrus sinensis.  f35 Potato  Solanum tuberosum.  f43 Mother's milk  Homo sapiens.  f44 Strawberry  Fragaria vesca (Fragaria spp.). f45 Yeast, baker's  Saccharomyces cerevisiae.  f46 Pepper, Red  Capsicum annuum.  f47 Garlic  Allium sativum.  f48 Onion  Allium cepa.  f49 Apple  Malus x domestica (Malus spp.). f51 Bamboo shoot  Phyllostachys pubescens.  f52 Cacao/chocolate  Theobroma cacao.  f54 Sweet potato  Ipomoea batatas.  f55 Common millet  Panicum miliaceum.  f56 Foxtail millet  Setaria italica.  f57 Japanese millet  Echinochloa crus-galli.  f58 Pacific squid  Todarodes pacificus.  f59 Octopus  Octopus vulgaris (Octopus spp.). f63 Kefir NA.  f67 Parmesan cheese NA.  f81 Cheese, cheddar type NA.  f82 Cheese, mold type NA.  f83 Chicken  Gallus domesticus (Gallus gallus domesticus; Gallus spp.). f86 Parsley  Petroselinum crispum.  f87 Melon  Cucumis melo Cucumis melo + Citrullus lanatus.  f88 Mutton (lamb)  Ovis aries (Ovis spp.). f90 Malt  Hordeum vulgare.  f92 Banana  Musa spp. f93 Cacao  Theobroma cacao.  f94 Pear  Pyrus communis (Pyrus spp.). f97 Yam  Dioscorea spp.Dioscorea opposita.  f97 Chamomile tea  Matricaria chamomilla.  f98 Gliadin  Triticum aestivum (Triticum spp.). f102 Cantaloupe  Cucumis melo var. cantalupensis.  f105 Chocolate  Theobroma cacao.  f109 Cottonseed  Gossypium hirsutum.  f110 Giant radish  Raphanus sativus.  f118 Zucchini  Cucurbita pepo.  f119 Radish  Raphanus sativus.  f120 Venison  Capreolus capeolus.  f121 Pinto bean  Phaseolus vulgaris.  f122 Cheese, American NA.  f127 Black-eyed pea  Vigna unguiculata.  f131 Black Olive  Olea europaea.  f136 Red beet  Beta vulgaris var. conditiva.  f139 Goat's Cheese  Capra aegagrus.  f140 Bran NA.  f141 Corn (vegetables)  Zea mays.  f152 Green bell pepper  Capsicum annuum.  f155 Brewer's yeast  Saccharomyces carlsbergensis.  f157 Duck  Anas domesticus.  f158 Goose  Anser anser.  f160 Camembert cheese NA.  f162 Nectarine  Prunus persica var. nucipersica.  f163 Kohlrabi  Brassica oleracea var. gongylodes.  f65 Perch   f166 Leek  Allium porrum.  f170 Cheese (Switzerland) (Swiss cheese) NA.  f174 Fig  Ficus carica.  f177 Cranberry  Vaccinium macrocarpon.  f179 Raisin  Vitis spp. f182 Lima bean  Phaseolus lunatus.  f198 Flaxseed (bruised grain)  Linum usitatissimum.  f199 Untreated native milk  Bos domesticus (Bos taurus; Bos spp.). f208 Lemon  Citrus limon.  f209 Grapefruit  Citrus paradisi.  f210 Pineapple  Ananas comosus.  f211 Blackberry  Rubus fruticosus.  f212 Mushroom (champignon)  Agaricus hortensis (Agaricus spp.). f213 Rabbit  Oryctolagus cuniculus (Oryctolagus spp.). f214 Spinach  Spinacia oleracea.  f215 Lettuce  Lactuca sativa.  f216 Cabbage  Brassica oleracea var. capitata.  f217 Brussels sprouts  Brassica oleracea var. gem.  f218 Paprika, sweet pepper  Capsicum annuum.  f219 Fennel seed  Foeniculum vulgare.  f219 Sage  Salvia officinalis.  f220 Cinnamon  Cinnamomum spp. f221 Coffee  Coffea spp. f222 Tea  Camellia sinensis.  f223 Green olive  Olea europaea.  f225 Summer squash, pumpkin  Cucurbita pepo.  f225 Pumpkin  Cucurbita maxima.  f226 Pumpkin seed  Cucurbita pepo.  f227 Sugar-beet seed  Beta vulgaris.  f229 Safflower Seed  Carthamus tinctorius.  f231 Milk, boiled  Bos domesticus (Bos taurus; Bos spp.). f234 Vanilla  Vanilla planifolia.  f237 Apricot  Prunus armeniaca.  f241 Gouda cheese NA.  f242 Cherry  Prunus avium.  f244 Cucumber  Cucumis sativus.  f246 Guar, guar gum  Cyamopsis tetragonoloba.  f247 Honey NA.  f248 Rosemary  Rosmarinus officinalis.  f254 Plaice  Pleuronectes platessa.  f255 Plum  Prunus domestica ,Prunus americana.  f258 Squid  Loligo spp. f259 Grape  Vitis vinifera (Vitis spp.). f260 Broccoli  Brassica oleracea var. italica (Brassica oleracea var. cultivar ). f261 Asparagus  Asparagus officinalis.  f262 Aubergine, eggplant  Solanum melongena.  f263 Green pepper  Piper nigrum ,Capsicum annuum.  f264 Eel  Anguilla anguilla.  f265 Caraway  Carum carvi.  f265 Cumin  Cuminum cyminum.  f266 Mace  Myristica fragrans.  f267 Cardamon  Elettaria cardamomum.  f268 Clove  Syzygium aromaticum.  f269 Basil  Ocimum basilicum.  f270 Ginger  Zingiber officinale.  f271 Anise  Pimpinella anisum.  f272 Tarragon  Artemisia dracunculus.  f273 Thyme  Thymus vulgaris.  f274 Marjoram  Origanum majorana.  f275 Lovage  Levisticum officinale.  f276 Fennel, fresh  Foeniculum vulgare.  f277 Dill  Anethum graveolens.  f278 Bay leaf  Laurus nobilis.  f279 Chili pepper  Capsicum frutescens.  f280 Black pepper  Piper nigrum.  f281 Curry (Santa Maria) NA.  f282 Nutmeg  Myristica fragrans.  f283 Oregano  Origanum vulgare.  f284 Turkey meat  Meleagris gallopavo.  f285 Elk/moose meat  Alces spp. f286 Mare's milk  Equus caballus (Equus spp.). f287 Red kidney bean  Phaseolus vulgaris.  f288 Blueberry  Vaccinium myrtillus (Vaccinium spp.). f289 Date  Phoenix dactylifera.  f291 Cauliflower  Brassica oleracea var. botrytis.  f292 Guava  Psidium guajava.  f293 Papaya  Carica papaya.  f294 Passion fruit, Maracuja  Passiflora edulis (Passiflora spp.). f295 Carambola  Averrhoa carambola.  f296 Carob  Ceratonia siliqua.  f297 Gum Arabic  Acacia senegal (Acacia spp.). f298 Tragacanth  Astragalus spp. f299 Sweet chestnut (chestnut)  Castanea sativa.  f300 Pinto bean  Phaseolus spp. f301 Persimmon (kaki fruit, sharon)  Diospyros kaki.  f302 Mandarin (tangerine, clementine, satsumas)  Citrus reticulata.  f305 Fenugreek  Trigonella foenum-graecum.  f306 Lime  Citrus aurantifolia.  f307 Hake  Merluccius merluccius.  f308 Sardine (pilchard)  Sardina pilchardus.  f310 Blue vetch  Lathyrus sativus.  f311 Megrim  Lepidorhombus whiffiagonis.  f315 Green bean  Phaseolus vulgaris.  f316 Rape seed  Brassica napus.  f317 Coriander  Coriandrum sativum.  f318 Jack fruit  Artocarpus heterophyllus.  f319 Beetroot  Beta vulgaris.  f320 Crayfish  Astacus astacus.  f321 Horse meat  Equus caballus (Equus spp.). f322 Red currant  Ribes sylvestre.  f324 Hop (fruit cone)  Humulus lupulus.  f325 Saffron  Colchicum autumnale.  f328 Fig  Ficus carica.  f329 Watermelon  Citrullus lanatus.  f330 Rose hip  Rosa spp. f331 Saffron  Crocus sativus.  f332 Mint  Mentha piperita.  f333 Linseed  Linum usitatissimum.  f336 Jujube  Ziziphus jujuba.  f336 Wine vinegar  Vitis vinifera (Vitis spp.). f337 Sole  Solea solea.  f337 English sole  Parophrys vetulus.  f338 Wine, white  Vitis vinifera (Vitis spp.). f339 Allspice  Pimenta dioica.  f339 Wine, red  Vitis vinifera (Vitis spp.). f341 Cranberry  Vaccinium oxycoccus ,Vaccinium macrocarpon.  f342 Olive (black, fresh)  Olea europaea.  f343 Raspberry  Rubus idaeus.  f344 Sage  Salvia officinalis.  f346 Chives  Allium schoenoprasum.  f347 Quinoa  Chenopodium quinoa.  f348 Litchi  Litchi chinensis.  f349 Chum salmon roe  Oncorhynchus keta.  f358 Artichoke  Cynara scolymus.  f360 Yogurt NA.  f368 Black bass  Micropterus dolomieu (Micropterus dolomieui ). f374 Karaya gum  Sterculia urens.  f375 Horseradish  Armoracia rusticana.  f377 Maple syrup NA.  f379 Okra  Abelmoschus esculentus.  f382 Beet, sugar  Beta vulgaris var. altissima.  f401 Loquat  Eriobotrya japonica.  f402 Fig  Ficus carica.  f403 Brewer's yeast  Saccharomyces cerevisiae.  f405 Mint  Mentha spp. f406 Arugula  Eruca vesicaria.   House Dust  h1 Greer Labs., Inc NA.  h2 Hollister-Stier Labs NA.  h6 Japan NA.   Venoms & Insects  i7 Midge  Chironomus yoshimatsui.  i8 Moth  Bombyx mori ,Heterocera spp. i47 Water flea  Daphnia spp. i49 Deer fly  Chrysops spp. i51 Black ant  Camponotus pennsylvanicus.  i54 Flea mix (dog/cat), common flea  Ctenocephalides spp. i71 Mosquito  Aedes communis ,Aedes spp.and Culex spp. i72 Green nimitti  Cladotanytarsus lewisi.  i73 Blood worm  Chironomus thummi ,Chironomusri parius ,Chironomus spp. i75 European hornet  Vespa crabro.  i76 Berlin beetle  Trogoderma angustum.  i77 European paper wasp  Polistes dominulus.  i78 Fly  Musca domestica.  i80 Bumblebee  Bombus pennsylvanicus.  i201 Horse bot fly  Gasterophilus intestinalis.  i202 Grain weevil  Sitophilus granarius.  i203 Mediterranean flour moth  Ephestia kuehniella (Anagasta kuehniella ). i204 Horse fly  Tabanus spp. i205 Bumblebee  Bombus terrestris.  i208 Api m 1.0101  Apis mellifera.  a45 Api m 1  Apis mellifera.  i209 Ves v 5.0101  Vespula vulgaris.  a670 Ves v 5  Vespula vulgaris.  i210 Pol d 5.0101  Polistes dominulus.  i211 Ves v 1.0101  Vespula vulgaris.  i213 Api m 4  Apis mellifera.  i214 Api m 2  Apis mellifera.  i215 Api m 3  Apis mellifera.  i216 Api m 5  Apis mellifera.  i217 Api m 10  Apis mellifera.  i220 Bla g 1.0101  Blattella germanica.  i221 Bla g 2.0101  Blattella germanica.  i222 Bla g 5.0101  Blattella germanica.  i223 Bla g 7  Blattella germanica.  a46 Api m 2  Apis mellifera.   Miscellaneous  o1 Cotton, crude fibers  Gossypium spp. o3 Cotton (treated)  Gossypium spp. o70 Seminal fluid  Homo sapiens.  o71  Staphylococcus aureus  Staphylococcus aureus.  o72  Pichia pastoris crude extract customer specific Pichia pastoris.  o72 Sperm-sediment  Homo sapiens.  o73  Pichia pastoris crude extr. vector customer specific Pichia pastoris.  o74  Pichia pastoris with vector customer specific Pichia pastoris.  o201 Tobacco leaf, tobacco dust  Nicotiana tabacum.  o202 Artemia salina, fish feed  Artemia salina.  o203 Tetramin, fish feed NA.  o207 Daphnia, fish feed  Daphnia spp. o211 Mealworm  Tenebrio molitor.  o212 Streptavidin  Streptomyces avidini.  o213 MBP (maltose binding protein)  Escherichia coli.  o214 CCD; MUXF3 from bromelain  Ananas comosus.  o72 Enterotoxin A (Sta a SEA)  Staphylococcus aureus.  o73 Enterotoxin B (Sta a SEB)  Staphylococcus aureus.   Parasites  p1 Ascaris  Ascaris suum.  p2 Echinococcus  Echinococcus granulosus.  p3 Schistosoma  Schistosoma mansoni.  p4 Anisakis (Herring Worm)  Anisakis simplex (Anisakis spp.). p5 Toxocara canis  Toxocara canis.  p10 Ani s 3.0101  Anisakis simplex (Anisakis spp.). p11 Ani s 1  Anisakis simplex (Anisakis spp.).  Occupational  k4 Threshing dust NA.  k5 Flax NA.  k7 Hay Dust NA.  k8 Hop (hops)  Humulus lupulus.  k12 Grain mill dust NA.  k14 Kapok NA.  k20 Sheep's wool (treated) (wool)  Ovis aries (Ovis spp.). k21 Sheep's wool (Untreated)  Ovis aries (Ovis spp.). k23 Straw Dust NA.  k33 Oak NA.  k70 Green coffee bean  Coffea spp. k71 Castor bean  Ricinus communis.  k72 Ispaghula  Plantago psyllium/Plantago ovata.  k73 Silk waste NA.  k74 Silk  Bombyx mori.  k75 Isocyanate TDI (Toluene diisocyanate) NA.  k76 Isocyanate MDI (Diphenylmethane diisocyanate) NA.  k77 Isocyanate HDI (Hexamethylen diisocyanate) NA.  k78 Ethylene oxide NA.  k79 Phthalic anhydride NA.  k80 Formaldehyde/Formalin NA.  k81 Ficus  Ficus benjamina (Ficus spp.). k83 Cotton seed  Gossypium hirsutum.  k84 Sunflower seed  Helianthus annuus.  k85 Chloramin T NA.  k86 Trimellitic anhydride, TMA NA.  k87 Asp o 21, alpha-amylase  Aspergillus oryzae.  k89 Orris root  Iris florentina.  k99 HSA (Human Serum Albumin) (Hom s HSA)  Homo sapiens.  k201 Car p 1, Papain  Carica papaya.  k202 Ana c 2, Bromelain  Ananas comosus.  k204 Maxatase  Bacillus licheniformis.  k205 Alcalase  Bacillus spp. k206 Savinase, Protease 1 (Bac l Subtilisin)  Bacillus spp. k208 Gal d 4, Lysozyme  Gallus domesticus (Gallus gallus domesticus; Gallus spp.). k209 Hexahydrophtalic anhydrid NA.  k210 Maleic anhydride NA.  k211 Methyltetrahydrophtalic anhydrid NA.  k212 Abachi wood dust  Triplochiton scleroxylon.  k213 Pepsin (Sus s Pepsin)  Sus scrofa (Sus scrofa domesticus; Sus spp.). k213 TCPA NA.  k214 Bougainvillea  Bougainvillea spp. k225 Horse radish peroxidase (Arm r HRP)  Armoracia rusticana.  k226 Ascorbate oxidase (Cuc p ascorbate oxidase)  Cucurbita pepo.  k301 Flour dust  Triticum spp. k501 Savinase customer specific Proprietary knowledge of customer.  k502 Lipolase customer specific Proprietary knowledge of customer.  k503 Termamyl customer specific Proprietary knowledge of customer.  k504 Clazinase customer specific Proprietary knowledge of customer.

## Predicate Devices

- ImmunoCAP Specific IgE Assay and ImmunoCAP Specific IgE Conjugate 100 and Conjugate 400 ([K051218](/device/K051218.md))

## Submission Summary (Full Text)

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>
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{0}

FDA U.S. FOOD & DRUG ADMINISTRATION

April 23, 2025

Hycor Biomedical
Aashrey Kaul
Regulatory Affairs Manager
7272 Chapman Avenue
Garden Grove, California 92841

Re: K242531

Trade/Device Name: NOVEOS Specific IgE (sIgE) Assay
Capture Reagent G010, Johnson Grass (Sorghum halepense);
Capture Reagent T007, Oak (Quercus alba);
Capture Reagent G002, Bermuda Grass (Cynodon dactylon);
Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia);
Capture Reagent E005, Dog Dander (Canis familiaris);
Capture Reagent T003, Common Silver Birch (Betula verrucosa);
Capture Reagent F001, Egg White (Gallus gallus);
Capture Reagent F002, Cow's Milk (Bos taurus)

Regulation Number: 21 CFR 866.5750
Regulation Name: Radioallergosorbent (RAST) Immunological Test System
Regulatory Class: Class II
Product Code: DHB
Dated: March 21, 2025
Received: March 24, 2025

Dear Aashrey Kaul:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

{1}

K242531 - Aashrey Kaul
Page 2

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

{2}

K242531 - Aashrey Kaul
Page 3

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Ying Mao -S

Ying Mao, Ph.D.
Branch Chief
Division of Immunology and Hematology Devices
OHT7: Office of In Vitro Diagnostics
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

{3}

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known)
K242531

## Device Name

NOVEOS Specific IgE (sIgE) Assay
Capture Reagent G010, Johnson Grass (Sorghum halepense);
Capture Reagent T007, Oak (Quercus alba);
Capture Reagent G002, Bermuda Grass (Cynodon dactylon);
Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia);
Capture Reagent E005, Dog Dander (Canis familiaris);
Capture Reagent T003, Common Silver Birch (Betula verrucosa);
Capture Reagent F001, Egg White (Gallus gallus);
Capture Reagent F002, Cow's Milk (Bos taurus)

## Indications for Use (Describe)

The NOVEOS Specific IgE Assay is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum. NOVEOS Specific IgE Assay is to be used with the NOVEOS Immunoassay Analyzer. It is intended for use as an in vitro diagnostic aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings and is to be used in clinical laboratories.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

## NOVEOS Specific IgE

This 510(k) summary is prepared in accordance with the requirements of 21 CFR Part 807.92.

Date of Preparation: 21st April 2025

Manufacturer: Hycor Biomedical, LLC
7272 Chapman Avenue
Garden Grove, CA 92841

Contact Person: Aashrey Kaul
Regulatory Affairs Manager
7272 Chapman Ave
Garden Grove, CA 92841
(714) 933-3067
akaul@hycorbiomedical.com

## Device Name:

NOVEOS™ Specific IgE (sIgE) Assay
Capture Reagent G010, Johnson Grass (Sorghum halepense);
Capture Reagent T007, Oak (Quercus alba);
Capture Reagent G002, Bermuda Grass (Cynodon dactylon);
Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia);
Capture Reagent E005, Dog Dander (Canis familiaris);
Capture Reagent T003, Common Silver Birch (Betula verrucosa);
Capture Reagent F001, Egg White (Gallus gallus);
Capture Reagent F002, Cow's Milk (Bos taurus);

## Classification

NOVEOS™ Specific IgE (sIgE) Assay
Product Code: DHB
Class: II
CFR § 866.5750
Substantial Equivalence to: K051218
ImmunoCAP Specific IgE Assay
ImmunoCAP Allergens g10, t7, g2, w1, e5, t3, f1, and f2.

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## Indications for Use/ Intended Use

The NOVEOS™ Specific IgE Assay is an *in vitro* quantitative assay for the measurement of allergen specific IgE in human serum. NOVEOS Specific IgE Assay is to be used with the NOVEOS Immunoassay Analyzer. It is intended for use as an *in vitro* diagnostic aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings and is to be used in clinical laboratories.

## General Description

### Reagents

The IgE Common reagents includes: Diluent A, Conjugate IgE, Substrate A, Substrate B, Fluo Beads™. Other required and recommended reagents include the allergen specific Capture Reagent, IgE Calibrator Set (6 levels (kU/L) - Cal 0.07 IgE, Cal 0.35 IgE, Cal 0.70 IgE, Cal 3.5 IgE, Cal 17.5 IgE, Cal 100 IgE), Calibrator Antibody IgE, Probe Wash Pack, Wash Buffer Concentrate, Cuvette Wash Pack, IgE Negative Control Pack, and IgE Positive Control Pack.

### Assay Principle

The NOVEOS Specific IgE Assay is an immunometric, chemiluminescent procedure for the quantitative determination of IgE of known specificity in human serum samples. It employs fluorescent labelled magnetic, streptavidin coated microparticles which are incubated with a biotinylated allergenic capture reagent, patient sample and monoclonal anti-human IgE antibody: horseradish peroxidase conjugate. If present in the sample, IgE binds to the biotinylated allergen captured to the streptavidin-coated microparticles to form a complex. After a final wash, the resulting complex is incubated with the enzyme substrate and a chemiluminescent signal is generated, the magnitude of which is proportional to the concentration of IgE in the patient sample.

The concentration of allergen-specific IgE is determined from a standard curve, which is traceable to the World Health Organization (WHO) reference reagent serum Immunoglobulin E (IgE) 11/234.

### Device Comparison

NOVEOS Specific IgE Assay on the NOVEOS Immunoassay Analyzer is comparable to ImmunoCAP Specific IgE on the Phadia 100 or 250 Analyzer. Both are automated immunoassay systems that process all assay steps and automatically generate results. See the table on the next page.

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|  Similarities and Differences  |   |   |
| --- | --- | --- |
|  General Device Characteristic | NOVEOS sIgE Assay | ImmunoCAP Specific IgE  |
|  Intended Use | The NOVEOS Specific IgE Assay is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum. NOVEOS Specific IgE Assay is to be used with the NOVEOS Immunoassay Analyzer. It is intended for use as an in vitro diagnostic aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings and is to be used in clinical laboratories. | ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma (EDTA or Na-Heparin). ImmunoCAP Specific IgE is to be used with instruments Phadia 100, Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings, and is to be used in clinical laboratories.  |
|  Specimen Type | Serum | Serum or plasma (EDTA, Na Heparin)  |
|  Sample Volume | 4 μL | 40 μL  |
|  Assay Type | Quantitative | Same  |
|  Detection Antibody | Horseradish peroxidase conjugated mouse anti-human IgE monoclonal antibody | β-Galactosidase-anti-human IgE (mouse monoclonal antibody)  |
|  Detection Limit | G010, Johnson Grass: LoB: 0.03 kU/L LoD: 0.06 kU/L LoQ: 0.10 kU/L T007, Oak: LoB: 0.04 kU/L LoD: 0.05 kU/L LoQ: 0.10 kU/L G002, Bermuda Grass: LoB: 0.03 kU/L LoD: 0.05 kU/L LoQ: 0.010 kU/L | LoB: 0.001 kU/L LoD: 0.02 kU/L LoQ: 0.10 kU/L  |

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|   | W001, Common Ragweed:
LoB: 0.03 kU/L
LoD: 0.05 kU/L
LoQ: 0.10 kU/L

E005, Dog Dander:
LoB: 0.03 kU/L
LoD: 0.06 kU/L
LoQ: 0.16kU/L

T003, Common Silver Birch:
LoB: 0.04 kU/L
LoD: 0.08 kU/L
LoQ: 0.10 kU/L

F001, Egg White:
LoB: 0.02 kU/L
LoD: 0.04 kU/L
LoQ: 0.14 kU/L

F002, Cow’s Milk:
LoB: 0.03 kU/L
LoD: 0.05 kU/L
LoQ: 0.10 kU/L |   |
| --- | --- | --- |
|  Laboratory Setting | Clinical Laboratory | Same  |
|  Assay Principles | Fluorescence adjusted, immunometric, chemiluminescent assay | Fluoroenzyme-immunoassay  |
|  Solid Phase | Magnetic microparticles | Cellulose derivative  |
|  Calibrator Traceability | World Health Organization (WHO) reference reagent serum Immunoglobulin E (IgE) 11/234 | Same  |
|  Calibration Method | Heterologous interpolation based on Total IgE calibration curve | Same  |
|  Stored Calibration Curve | Yes, up to 28 days | Same  |
|  Number of Calibrators | Six | Same  |
|  Calibrator Levels | 0, 0.35, 0.7, 3.5, 17.5 and 100 kU/L | Same  |

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|  Assay Range | G010, Johnson Grass: 0.10 – 100 kU/L
T007, Oak: 0.10 – 100 kU/L
G002, Bermuda Grass: 0.10- 100 kU/L
W001, Common Ragweed: 0.10 – 100 kU/L
E005, Dog Dander: 0.16 – 100 Ku/L
T003, Common Silver Birch: 0.10 – 100 kU/L
F001, Egg White: 0.14 – 100 kU/L
F002, Cow’s Milk: 0.10 – 100 kU/L | Same  |
| --- | --- | --- |
|  Reaction Temperature | 37°C | Same  |
|  Instrument(s) | NOVEOS Immunoassay Analyzer | Phadia 100, Phadia 250/1000/2500/5000  |
|  Time to First Result | 1 hour 45 minutes | 1 hour 45 minutes to 2 hour 30 minutes depending on model  |

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# Clinical Performance

In addition to the ImmunoCAP comparison study, a clinical study that compares NOVEOS sIgE allergen results to the allergic status of 102 to 228 patients was performed to support the diagnostic performance of the NOVEOS sIgE allergens G010 (Johnson Grass), T007 (Oak), G002 (Bermuda Grass), W001 (Common Ragweed), E005 (Dog Dander), T003 (Common Silver Birch), F001 (Egg White), and F002 (Cow's Milk). A total of 32 to 88 samples with allergic status (atopic) was confirmed by skin-prick testing or oral food challenge, and the other 53 to 146 samples were deemed negative (non-atopic) by ImmunoCAP testing (result <0.35 kU/L).

Results are expressed as positive when a sample has an sIgE value greater than or equal to 0.35 kU/L, and negative when a sample has an sIgE value is less than 0.35 kU/L.

Clinical sensitivity and specificity for each allergen under evaluation are summarized in the following table:

|  NOVEOS sIgE Allergens | Clinical Diagnosis  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Atopic | Non-Atopic | Total  |
|  G010, Johnson Grass | Positive | 62 | 1 | 63  |
|   |  Negative | 23 | 132 | 155  |
|   |  Total | 85 | 133 | 218  |
|   |  Clinical sensitivity: 72.9% (62/85) 95% CI 62.7% to 81.2%
Clinical specificity: 99.2% (132/133) 95% CI 95.9% to 99.9%  |   |   |   |
|  T007, Oak | Positive | 38 | 2 | 40  |
|   |  Negative | 15 | 91 | 106  |
|   |  Total | 53 | 93 | 146  |
|   |  Clinical sensitivity: 71.7% (38/53) 95% CI 58.4% to 82.0%
Clinical specificity: 97.8% (91/93) 95% CI 92.5% to 99.4%  |   |   |   |
|  G002, Bermuda Grass | Positive | 67 | 4 | 71  |
|   |  Negative | 21 | 136 | 157  |
|   |  Total | 88 | 140 | 228  |
|   |  Clinical sensitivity: 76.1% (67/88) 95% CI 66.3% to 83.8%
Clinical specificity: 97.1% (136/140) 95% CI 92.9% to 98.9%  |   |   |   |
|  W001, Common Ragweed | Positive | 44 | 6 | 50  |
|   |  Negative | 27 | 88 | 115  |
|   |  Total | 71 | 94 | 165  |
|   |  Clinical sensitivity: 62.0% (44/71) 95% CI 50.3% to 72.4%
Clinical specificity: 93.6% (88/94) 95% CI 86.8% to 97.0%  |   |   |   |
|  E005, Dog Dander | Positive | 23 | 0 | 23  |
|   |  Negative | 9 | 77 | 86  |
|   |  Total | 32 | 77 | 109  |
|   |  Clinical sensitivity: 71.9% (23/32) 95% CI 54.6% to 84.4%
Clinical specificity: 100.0% (77/77) 95% CI 95.2% to 100.0%  |   |   |   |

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|  NOVEOS sIgE Allergens | Clinical Diagnosis  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Atopic | Non-Atopic | Total  |
|  T003, Common Silver Birch | Positive | 27 | 0 | 27  |
|   |  Negative | 22 | 53 | 75  |
|   |  Total | 49 | 53 | 102  |
|   |  Clinical sensitivity: 55.1% (27/49) 95% CI 41.3% to 68.1%
Clinical specificity: 100.0% (53/53) 95% CI 93.2% to 100.0%  |   |   |   |
|  F001, Egg White | Positive | 19 | 0 | 19  |
|   |  Negative | 17 | 146 | 163  |
|   |  Total | 36 | 146 | 182  |
|   |  Clinical sensitivity: 52.8% (19/36) 95% CI 37.0% to 68.0%
Clinical specificity: 100.0% (146/146) 95% CI 97.4% to 100.0%  |   |   |   |
|  F002, Cow's Milk | Positive | 17 | 0 | 17  |
|   |  Negative | 17 | 132 | 149  |
|   |  Total | 34 | 132 | 166  |
|   |  Clinical sensitivity: 50.0% (17/34) 95% CI 34.1% to 65.9%
Clinical specificity: 100.0% (132/132) 95% CI 97.2% to 100.0%  |   |   |   |

The following literature was published to support the observed low performance, especially sensitivity, from the NOVEOS sIgE Assay, T003, F001, and F002:

|  NOVEOS sIgE Assay | Literature Citation(s) | Prevalence | Reported Performance  |
| --- | --- | --- | --- |
|  T003, Oak Sensitivity: 55.1%
Specificity: 100% | Knight, V., et al., (2018). Journal of Immunological Methods, 462, 9-12. | Not reported | 53% (95 CI: 29% to 76%) - concordance of SPT vs. sIgE  |
|   |  Salo, P. M., et al., (2014). The Journal of Allergy and Clinical Immunology, 134(2), 350-359. | ~12% in subjects ≥6 years old in US | Not reported  |
|  F001, Egg White
Sensitivity: 52.8%
Specificity: 100% | Nacaroglu HT, et al. (2017) Allergol Immunopathol (Madr). | Not reported | Sensitivity: 41.3%
Specificity: 86.67%  |
|   |  Salo, P. M., et al., (2014). The Journal of Allergy and Clinical Immunology, 134(2), 350-359. | 3.5% in subjects ≥6 years old in US | Not reported  |
|   |  Min, T. K., et al. (2013). Allergy, Asthma & Immunology Research, 5(3), 138-142. | Not reported (study done in subjects <2 years old in Korea) | Sensitivity: 60.0%
Specificity: 62.5% (with 2 kUA/L as cut-off)  |
|  F002, Cow's Milk
Sensitivity: 50.0%
Specificity: 100% | Sampson H. A. (2001). The Journal of Allergy and Clinical Immunology, 107(5), 891-896. | Not reported | Sensitivity: 51%
PPV: 95%  |
|   |  Salo, P. M., et al., (2014). The Journal of Allergy and Clinical Immunology, 134(2), 350-359. | 5.7% (in 8203 subjects between 1 to >60 years old in US) | Not reported  |
|   |  Mehl, A., et al. (2012). Journal of the British Society for Allergy and Clinical Immunology, 42(8), 1266-1272. | Not reported | "low" between sIgE vs SPT on an individual basis  |

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# Method Comparison to ImmunoCAP

Method comparison studies to evaluate the performance of the NOVEOS sIgE allergens to ImmunoCAP were completed using 175 to 268 patient samples. Results for NOVEOS sIgE and ImmunoCAP allergens are expressed as positive when a sample has a value greater than or equal to  $0.35\mathrm{kU / L}$ , and negative when a sample has an sIgE value is less than  $0.35\mathrm{kU / L}$ . Percent positive and negative agreement for each allergen under evaluation are summarized in the following table:

|  NOVEOS sIgE Allergens | ImmunoCAP sIgE  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Positive | Negative | Total  |
|  G010, Johnson Grass | Positive | 100 | 1 | 101  |
|   |  Negative | 18 | 134 | 152  |
|   |  Total | 118 | 135 | 253  |
|   |  Positive Agreement: 84.7% (100/118) 95% CI: 77.2% to 90.1% Negative Agreement: 99.3% (134/135) 95% CI: 95.9% to 99.9% Total Agreement: 92.5% (234/253) 95% CI: 88.6% to 95.1%  |   |   |   |
|  T007, Oak | Positive | 124 | 6 | 130  |
|   |  Negative | 24 | 106 | 130  |
|   |  Total | 148 | 112 | 260  |
|   |  Positive Agreement: 83.8% (124/148) 95% CI: 77.0% to 88.9% Negative Agreement: 94.6% (106/112) 95% CI: 88.8% to 97.5% Total Agreement: 88.5% (230/260) 95% CI: 84.0% to 91.8%  |   |   |   |
|  G002, Bermuda Grass | Positive | 93 | 5 | 98  |
|   |  Negative | 11 | 150 | 161  |
|   |  Total | 104 | 155 | 259  |
|   |  Positive Agreement: 89.4% (93/104) 95% CI: 82.0% to 94.0% Negative Agreement: 96.8% (150/155) 95% CI: 92.7% to 98.6% Total Agreement: 93.8% (243/259) 95% CI: 90.2% to 96.2%  |   |   |   |
|  W001, Common Ragweed | Positive | 99 | 5 | 104  |
|   |  Negative | 37 | 95 | 132  |
|   |  Total | 136 | 100 | 236  |
|   |  Positive Agreement: 72.8% (99/136) 95% CI: 64.8% to 79.6% Negative Agreement: 95.0% (95/100) 95% CI: 88.8% to 97.8% Total Agreement: 82.2% (194/236) 95% CI: 76.8% to 86.6%  |   |   |   |

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|  NOVEOS sIgE Allergens | ImmunoCAP sIgE  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Positive | Negative | Total  |
|  E005, Dog Dander | Positive | 88 | 3 | 91  |
|   |  Negative | 8 | 88 | 96  |
|   |  Total | 96 | 91 | 187  |
|   |  Positive Agreement: 91.7% (88/96) 95% CI 84.4% to 95.7%
Negative Agreement: 96.7% (88/91) 95% CI 90.8% to 98.9%
Total Agreement: 94.1% (176/187) 95% CI: 89.8% to 96.7%  |   |   |   |
|  T003, Common Silver Birch | Positive | 95 | 3 | 98  |
|   |  Negative | 4 | 73 | 77  |
|   |  Total | 99 | 76 | 175  |
|   |  Positive Agreement: 96.0% (95/99) 95% CI: 90.1% to 98.4%
Negative Agreement: 96.1% (73/76) 95% CI: 89.0% to 98.6%
Total Agreement: 96.0% (168/175) 95% CI: 92% to 98%  |   |   |   |
|  F001, Egg White | Positive | 69 | 7 | 76  |
|   |  Negative | 8 | 179 | 187  |
|   |  Total | 77 | 186 | 263  |
|   |  Positive Agreement: 89.6% (69/77) 95% CI: 80.8% to 94.6%
Negative Agreement: 96.2% (179/186) 95% CI: 92.4% to 98.2%
Total Agreement: 94.3% (248/263) 95% CI: 90.8% to 96.5%  |   |   |   |
|  F002, Cow's Milk | Positive | 60 | 2 | 62  |
|   |  Negative | 33 | 173 | 206  |
|   |  Total | 93 | 175 | 268  |
|   |  Positive Agreement: 64.5% (60/93) 95% CI: 54.5% to 73.5%
Negative Agreement: 98.9% (173/175) 95% CI: 95.9% to 99.7%
Total Agreement: 86.9% (233/268) 95% CI: 82.4% to 90.5%  |   |   |   |

## Precision/Reproducibility

Repeatability and within-laboratory precision of NOVEOS sIgE allergens were determined in accordance with CLSI guideline EP05-A3: Evaluation of Precision of Quantitative Measurement Procedures – 3rd Edition and CLSI guideline EP15-A3: User Verification of Precision and Estimation of Bias – 3rd Edition. A panel of four to five samples (two negative and two to three positive patient samples) was assayed in duplicate for two runs per day, over at least 20 days, on one NOVEOS Immunoassay Analyzer for a total of at least 80 replicates per sample. One lot of NOVEOS sIgE allergens were used for testing of each sample. The SD and % CV of the within-run, between-run, between-day, and total imprecision were calculated for each sample and results are summarized in the following table:

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|  Sample | N | Mean (kU/L) | Within-Run (Repeatability) |   | Between-Run |   | Between-Day |   | Total  |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |   |   |  SD | CV | SD | CV | SD | CV | SD | CV  |
|  NOVEOS G010, Johnson Grass  |   |   |   |   |   |   |   |   |   |   |
|  1 | 80 | 0.20 | 0.02 | 8.9% | 0.01 | 6.9% | 0.04 | 19.0% | 0.05 | 22.1%  |
|  2 | 80 | 0.36 | 0.01 | 4.0% | 0.02 | 6.0% | 0.03 | 9.4% | 0.04 | 11.8%  |
|  3 | 80 | 7.76 | 0.35 | 4.6% | 0.16 | 2.0% | 0.61 | 7.8% | 0.72 | 9.3%  |
|  4 | 80 | 34.56 | 1.19 | 3.5% | 1.07 | 3.1% | 3.09 | 8.9% | 3.48 | 10.1%  |
|  5 | 84* | 43.17 | 2.07 | 4.8% | 0.67 | 1.6% | 1.46 | 3.4% | 2.62 | 6.1%  |
|  * Sample 5 was done with 2 replicates/run x 2 runs/day x 22 days with exclusion of 2 outliers for Day 21 and only 1 run at Day 22  |   |   |   |   |   |   |   |   |   |   |
|  NOVEOS T007, Oak  |   |   |   |   |   |   |   |   |   |   |
|  1 | 80 | 0.20 | 0.01 | 5.8% | 0.01 | 4.7% | 0.01 | 6.3% | 0.02 | 9.8%  |
|  2 | 80 | 0.25 | 0.01 | 4.5% | 0.02 | 8.2% | 0.00 | 0.0% | 0.02 | 9.4%  |
|  3 | 80 | 1.72 | 0.07 | 4.2% | 0.13 | 7.8% | 0.12 | 6.9% | 0.19 | 11.2%  |
|  4 | 80 | 11.80 | 0.46 | 3.9% | 0.70 | 6.0% | 0.84 | 7.1% | 1.19 | 10.1%  |
|  5 | 84* | 96.20 | 4.74 | 4.9% | 4.35 | 4.5% | 4.40 | 4.6% | 7.79 | 8.1%  |
|  * Sample 5 was done with 2 replicates/run x 2 runs/day x 22 days with exclusion of 2 outliers for Day 21 and only 1 run at Day 22  |   |   |   |   |   |   |   |   |   |   |
|  NOVEOS G002, Bermuda Grass  |   |   |   |   |   |   |   |   |   |   |
|  1 | 80 | 0.14 | 0.01 | 7.5% | 0.01 | 4.0% | 0.01 | 7.4% | 0.02 | 11.3%  |
|  2 | 80 | 0.22 | 0.01 | 6.0% | 0.01 | 5.6% | 0.02 | 8.0% | 0.02 | 11.4%  |
|  3 | 80 | 9.14 | 0.38 | 4.1% | 0.53 | 5.8% | 0.64 | 7.0% | 0.91 | 10.0%  |
|  4 | 80 | 51.34 | 2.14 | 4.2% | 4.07 | 7.9% | 4.70 | 9.2% | 6.58 | 12.8%  |
|  NOVEOS W001, Common Ragweed  |   |   |   |   |   |   |   |   |   |   |
|  1 | 80 | 0.17 | 0.01 | 8.1% | 0.01 | 8.2% | 0.02 | 10.7% | 0.03 | 15.7%  |
|  2 | 80 | 0.29 | 0.02 | 7.4% | 0.01 | 3.8% | 0.02 | 6.5% | 0.03 | 10.6%  |
|  3 | 80 | 1.28 | 0.07 | 5.5% | 0.06 | 4.4% | 0.08 | 6.7% | 0.12 | 9.7%  |
|  4 | 80 | 6.28 | 0.22 | 3.5% | 0.22 | 3.5% | 0.37 | 5.9% | 0.48 | 7.7%  |
|  5 | 86* | 70.33 | 4.15 | 5.9% | 2.90 | 4.1% | 1.36 | 1.9% | 5.25 | 7.5%  |
|  * Sample 5 was done with 2 replicates/run x 2 runs/day x 22 days with only 1 run at Day 22  |   |   |   |   |   |   |   |   |   |   |
|  NOVEOS E005, Dog Dander  |   |   |   |   |   |   |   |   |   |   |
|  1 | 80 | 0.16 | 0.01 | 6.7% | 0.00 | 3.0% | 0.01 | 5.5% | 0.01 | 9.2%  |
|  2 | 80 | 0.34 | 0.01 | 3.9% | 0.02 | 6.0% | 0.01 | 4.2% | 0.03 | 8.3%  |
|  3 | 80 | 0.86 | 0.04 | 4.4% | 0.05 | 5.8% | 0.03 | 3.8% | 0.07 | 8.2%  |
|  4 | 80 | 9.14 | 0.40 | 4.4% | 0.69 | 7.5% | 0.31 | 3.4% | 0.85 | 9.3%  |
|  5 | 86* | 81.48 | 4.68 | 5.7% | 2.62 | 3.2% | 2.60 | 3.2% | 5.96 | 7.3%  |
|  * Sample 5 was done with 2 replicates/run x 2 runs/day x 22 days with only 1 run at Day 22  |   |   |   |   |   |   |   |   |   |   |

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|  Sample | N | Mean (kU/L) | Within-Run (Repeatability) |   | Between-Run |   | Between-Day |   | Total  |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |   |   |  SD | CV | SD | CV | SD | CV | SD | CV  |
|  NOVEOS T003, Common Silver Birch  |   |   |   |   |   |   |   |   |   |   |
|  1 | 80 | 0.21 | 0.02 | 10.6% | 0.00 | 0.0% | 0.02 | 9.9% | 0.03 | 14.5%  |
|  2 | 80 | 0.29 | 0.01 | 4.2% | 0.01 | 5.0% | 0.03 | 8.7% | 0.03 | 10.9%  |
|  3 | 80 | 1.31 | 0.10 | 7.7% | 0.02 | 1.5% | 0.06 | 4.6% | 0.12 | 9.1%  |
|  4 | 80 | 10.37 | 0.38 | 3.7% | 0.61 | 5.9% | 0.38 | 3.6% | 0.81 | 7.8%  |
|  5 | 86* | 92.31 | 7.05 | 7.6% | 5.01 | 5.4% | 1.70 | 1.8% | 8.82 | 9.6%  |
|  * Sample 5 was done with 2 replicates/run x 2 runs/day x 22 days with only 1 run at Day 22  |   |   |   |   |   |   |   |   |   |   |
|  NOVEOS F001, Egg White  |   |   |   |   |   |   |   |   |   |   |
|  1 | 80 | 0.14 | 0.01 | 4.2% | 0.01 | 4.8% | 0.00 | 0.0% | 0.01 | 6.4%  |
|  2 | 80 | 0.31 | 0.01 | 2.9% | 0.01 | 3.1% | 0.00 | 1.5% | 0.01 | 4.5%  |
|  3 | 80 | 1.21 | 0.03 | 2.4% | 0.04 | 3.6% | 0.02 | 1.8% | 0.06 | 4.7%  |
|  4 | 80 | 1.49 | 0.05 | 3.4% | 0.04 | 2.4% | 0.03 | 2.0% | 0.07 | 4.7%  |
|  5 | 83* | 78.75 | 4.30 | 5.5% | 1.95 | 2.5% | 3.33 | 4.2% | 5.77 | 7.3%  |
|  * Sample 5 was done with 2 replicates/run x 2 runs/day x 22 days with exclusion of 1 dropped test on Day 20 and only 1 run at Day 22  |   |   |   |   |   |   |   |   |   |   |
|  NOVEOS F002 (Cow's Milk)  |   |   |   |   |   |   |   |   |   |   |
|  1 | 80 | 0.18 | 0.02 | 9.7% | 0.00 | 2.6% | 0.01 | 3.4% | 0.02 | 10.6%  |
|  2 | 80 | 0.33 | 0.01 | 3.4% | 0.01 | 3.1% | 0.01 | 4.1% | 0.02 | 6.2%  |
|  3 | 80 | 3.91 | 0.11 | 2.9% | 0.14 | 3.6% | 0.10 | 2.6% | 0.21 | 5.3%  |
|  4 | 80 | 22.51 | 0.72 | 3.2% | 0.73 | 3.2% | 0.23 | 1.0% | 1.05 | 4.7%  |
|  5 | 86* | 59.43 | 3.34 | 5.6% | 2.02 | 3.4% | 4.93 | 8.3% | 6.29 | 10.6%  |
|  * Sample 5 was done with 2 replicates/run x 2 runs/day x 22 days with 1 run at Day 22  |   |   |   |   |   |   |   |   |   |   |

## Lot-to-lot imprecision

Lot-to-lot imprecision was evaluated using a panel of four serum samples tested with two to three different lots of each NOVEOS sIgE allergen. For NOVEOS sIgE allergens G002 (Bermuda Grass), F001 (Egg White), and F002 (Cow's Milk), the samples were tested in duplicate for two runs per day, over 20 days, for a total of 240 replicates per sample. For NOVEOS sIgE allergens T007 (Oak), W001 (Common Ragweed), E005 (Dog Dander), and T003 (Common Silver Birch), the samples were tested in replicates of five for one run per day, over at least 5 days, for a total of at least 50 replicates per sample. For NOVEOS sIgE allergen G010 (Johnson Grass), the samples were tested in duplicate for two runs per day, over 5 days, for a total of 60 replicates per sample. The results are summarized in the following table:

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|  Sample | N | Mean (kU/L) | Within-Run (Repeatability) |   | Between-Day |   | Between-Lot |   | Total  |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |   |   |  SD | CV | SD | CV | SD | CV | SD | CV  |
|  NOVEOS G010, Johnson Grass  |   |   |   |   |   |   |   |   |   |   |
|  1 | 60 | 0.18 | 0.02 | 11.6% | 0.03 | 14.9% | 0.01 | 6.3% | 0.04 | 19.9%  |
|  2 | 60 | 0.37 | 0.02 | 6.6% | 0.01 | 1.7% | 0.01 | 3.2% | 0.03 | 7.5%  |
|  3 | 60 | 8.15 | 0.46 | 5.7% | 0.14 | 1.7% | 0.00 | 0.0% | 0.48 | 5.9%  |
|  4 | 60 | 38.12 | 1.86 | 4.9% | 0.57 | 1.5% | 0.00 | 0.0% | 1.95 | 5.1%  |
|  NOVEOS T007, Oak  |   |   |   |   |   |   |   |   |   |   |
|  1 | 75 | 0.20 | 0.02 | 8.2% | 0.03 | 14.5% | 0.00 | 0.0% | 0.03 | 16.7%  |
|  2 | 75 | 0.44 | 0.02 | 5.6% | 0.04 | 8.2% | 0.00 | 0.0% | 0.04 | 9.9%  |
|  3 | 75 | 1.46 | 0.06 | 4.4% | 0.14 | 9.5% | 0.08 | 5.2% | 0.17 | 11.7%  |
|  4 | 75 | 10.07 | 0.37 | 3.7% | 0.51 | 5.1% | 0.38 | 3.7% | 0.73 | 7.3%  |
|  NOVEOS G002, Bermuda Grass  |   |   |   |   |   |   |   |   |   |   |
|  1 | 240 | 0.14 | 0.02 | 13.9% | 0.01 | 6.9% | 0.01 | 6.9% | 0.02 | 17.1%  |
|  2 | 240 | 0.23 | 0.03 | 11.8% | 0.02 | 9.0% | 0.02 | 7.4% | 0.04 | 16.8%  |
|  3 | 240 | 9.14 | 0.38 | 4.2% | 0.64 | 7.0% | 0.00 | 0.0% | 0.88 | 9.6%  |
|  4 | 240 | 51.00 | 2.46 | 4.8% | 4.67 | 9.1% | 0.00 | 0.0% | 6.43 | 12.6%  |
|  NOVEOS W001, Common Ragweed  |   |   |   |   |   |   |   |   |   |   |
|  1 | 75 | 0.18 | 0.01 | 8.0% | 0.01 | 5.7% | 0.01 | 7.9% | 0.02 | 12.6%  |
|  2 | 75 | 0.48 | 0.03 | 5.7% | 0.02 | 4.5% | 0.02 | 4.0% | 0.04 | 8.3%  |
|  3 | 75 | 1.27 | 0.05 | 4.3% | 0.06 | 4.8% | 0.00 | 0.0% | 0.08 | 6.5%  |
|  4 | 75 | 6.16 | 0.29 | 4.7% | 0.02 | 3.7% | 0.00 | 0.0% | 0.37 | 6.0%  |
|  NOVEOS E005, Dog Dander  |   |   |   |   |   |   |   |   |   |   |
|  1 | 75 | 0.14 | 0.01 | 8.2% | 0.01 | 9.0% | 0.01 | 4.2% | 0.02 | 12.9%  |
|  2 | 75 | 0.43 | 0.02 | 5.4% | 0.02 | 4.2% | 0.03 | 5.9% | 0.04 | 9.0%  |
|  3 | 75 | 0.79 | 0.04 | 5.1% | 0.04 | 4.7% | 0.03 | 3.6% | 0.06 | 7.8%  |
|  4 | 75 | 8.25 | 0.30 | 3.6% | 0.45 | 5.5% | 0.00 | 0.0% | 0.54 | 6.6%  |
|  NOVEOS T003, Common Silver Birch  |   |   |   |   |   |   |   |   |   |   |
|  1 | 50 | 0.11 | 0.01 | 8.6% | 0.01 | 10.6% | 0.00 | 0.0% | 0.01 | 13.6%  |
|  2 | 50 | 0.55 | 0.02 | 3.6% | 0.05 | 9.2% | 0.00 | 0.0% | 0.05 | 9.9%  |
|  3 | 50 | 1.54 | 0.06 | 3.7% | 0.05 | 3.2% | 0.00 | 0.0% | 0.08 | 4.9%  |
|  4 | 50 | 8.89 | 0.38 | 4.3% | 0.1 | 1.1% | 0.00 | 0.0% | 0.39 | 4.4%  |
|  NOVEOS F001, Egg White  |   |   |   |   |   |   |   |   |   |   |
|  1 | 240 | 0.15 | 0.02 | 15.0% | 0.00 | 0.0% | 0.01 | 4.5% | 0.02 | 16.0%  |
|  2 | 240 | 0.31 | 0.01 | 3.1% | 0.00 | 0.9% | 0.00 | 0.0% | 0.02 | 5.1%  |
|  3 | 240 | 1.20 | 0.03 | 2.8% | 0.02 | 1.5% | 0.01 | 1.2% | 0.06 | 4.8%  |
|  4 | 240 | 1.47 | 0.05 | 3.3% | 0.02 | 1.1% | 0.01 | 0.7% | 0.08 | 5.2%  |

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|  Sample | N | Mean (kU/L) | Within-Run (Repeatability) |   | Between-Day |   | Between-Lot |   | Total  |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |   |   |  SD | CV | SD | CV | SD | CV | SD | CV  |
|  NOVEOS F002, Cow's Milk  |   |   |   |   |   |   |   |   |   |   |
|  1 | 240 | 0.18 | 0.01 | 6.4% | 0.00 | 1.6% | 0.00 | 0.3% | 0.01 | 7.5%  |
|  2 | 240 | 0.35 | 0.01 | 3.1% | 0.01 | 2.7% | 0.01 | 4.2% | 0.02 | 6.4%  |
|  3 | 240 | 4.05 | 0.10 | 2.4% | 0.16 | 4.0% | 0.11 | 2.8% | 0.24 | 5.9%  |
|  4 | 240 | 22.35 | 0.62 | 2.8% | 0.76 | 3.4% | 0.04 | 0.2% | 1.04 | 4.7%  |

# Linearity

Linearity of NOVEOS sIgE allergens was evaluated in accordance with CLSI guideline I/LA20-3rd Edition, Analytical Performance Characteristics, Quality Assurance, and Clinical Utility of Immunological Assays for Human Immunoglobulin E Antibodies of Defined Allergen Specificities. Three sets of linearity dilution panels consisting of three neat positive human serum samples (low, mid, and high) were used for testing. One negative sample below the assay detection limit was used as the diluent. Each sample was serially diluted in a two-fold scheme (1/2, 1/4, 1/8, 1/16, and 1/32) to create the full dilution panel. Testing was performed using one lot of each NOVEOS sIgE allergen. The linear regression statistics calculated using the weighted least squares with intercept analysis per CLSI guideline EP06-2nd Edition, Evaluation of Linearity of Quantitative Measurement Procedures, are shown in the following tables:

|  NOVEOS Specific IgE Assay, G010, Johnson Grass  |   |   |   |   |
| --- | --- | --- | --- | --- |
|  Dilution Series | Dilution Range (kU/L) | Slope (95% CI) | Intercept (95% CI) | R²  |
|  1 | 0.10 – 3.26 | 0.99 (0.92 to 1.07) | -0.00 (-0.03 to 0.02) | 0.997  |
|  2 | 1.94 - 56.15 | 0.91 (0.85 to 0.97) | 0.23 (-0.00 to 0.46) | 0.998  |
|  3 | 3.16 - 111.01 | 0.90 (0.81 to 0.97) | -0.10 (-0.67 to 0.97) | 0.997  |
|  All | 0.10 - 111.01 | 0.95 (0.92 to 0.97) | 0.01 (-0.01 to 0.02) | 0.997  |
|  NOVEOS Specific IgE Assay, T007, Oak  |   |   |   |   |
| --- | --- | --- | --- | --- |
|  Dilution Series | Dilution Range (kU/L) | Slope (95% CI) | Intercept (95% CI) | R²  |
|  1 | 0.05 - 1.99 | 1.00 (0.86 to 1.13) | -0.01 (-0.02 to -0.00) | 0.987  |
|  2 | 0.63 - 42.05 | 0.95 (0.91 to 0.99) | -0.07 (-0.13 to 0.00) | 0.999  |
|  3 | 1.41 - 113.95 | 0.86 (0.80 to 0.91) | -0.19 (-0.48 to 0.10) | 0.997  |
|  All | 0.05 - 113.95 | 0.90 (0.86 to 0.94) | -0.01 (-0.01 to -0.00) | 0.991  |

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|  NOVEOS Specific IgE Assay, G002, Bermuda Grass  |   |   |   |   |
| --- | --- | --- | --- | --- |
|  Dilution Series | Dilution Range (kU/L) | Slope (95% CI) | Intercept (95% CI) | R²  |
|  1 | 0.06 - 2.94 | 0.96 (0.89 to 1.03) | -0.03 (-0.04 to -0.01) | 0.996  |
|  2 | 1.50 - 51.58 | 0.96 (0.90 to 1.01) | -0.25 (-0.53 to 0.03) | 0.998  |
|  3 | 2.90 - 111.89 | 1.00 (0.92 to 1.07) | -0.70 (-1.28 to -0.12) | 0.997  |
|  All | 0.06 - 111.89 | 0.93 (0.91 to 0.96) | -0.02 (-0.04 to -0.01) | 0.997  |
|  NOVEOS Specific IgE Assay, W001, Common Ragweed  |   |   |   |   |
| --- | --- | --- | --- | --- |
|  Dilution Series | Dilution Range (kU/L) | Slope (95% CI) | Intercept (95% CI) | R²  |
|  1 | 0.09 - 1.60 | 0.96 (0.92 to 1.00) | -0.01 (-0.02 to 0.01) | 0.999  |
|  2 | 0.74 - 49.27 | 0.96 (0.94 to 0.99) | -0.01 (-0.02 to 0.01) | 0.998  |
|  3 | 1.44 - 94.04 | 0.91 (0.85 to 0.97) | 0.06 (-0.10 to 0.22) | 0.997  |
|  All | 0.09 - 94.04 | 0.95 (0.93 to 0.97) | 0.00 (-0.02 to 0.01) | 0.998  |
|  NOVEOS Specific IgE Assay, E005, Dog Dander  |   |   |   |   |
| --- | --- | --- | --- | --- |
|  Dilution Series | Dilution Range (kU/L) | Slope (95% CI) | Intercept (95% CI) | R²  |
|  1 | 0.16 - 3.31 | 1.12 (1.00 to 1.24) | -0.00 (-0.03 to 0.06) | 0.994  |
|  2 | 0.37 - 19.3 | 1.06 (0.97 to 1.14) | 0.03 (-0.03 to 0.09) | 0.995  |
|  3 | 1.47 - 102.41 | 0.99 (0.97 to 1.01) | -0.15 (-0.22 to -0.08) | 1.000  |
|  All | 0.16 - 102.41 | 1.06 (1.01 to 1.11) | 0.03 (0.01 to 0.05) | 0.990  |
|  NOVEOS Specific IgE Assay, T003, Common Silver Birch  |   |   |   |   |
| --- | --- | --- | --- | --- |
|  Dilution Series | Dilution Range (kU/L) | Slope (95% CI) | Intercept (95% CI) | R²  |
|  1 | 0.08 - 3.28 | 1.00 (0.96 to 1.04) | -0.01 (-0.02 to -0.00) | 0.999  |
|  2 | 0.67 - 42.74 | 0.94 (0.87 to 1.02) | -0.06 (-0.26 to 0.13) | 0.995  |
|  3 | 1.30 - 92.17 | 0.99 (0.89 to 1.10) | -0.38 (-0.80 to 0.03) | 0.992  |
|  All | 0.08 - 92.17 | 0.93 (0.90 to 0.96) | 0.00 (-0.02 to 0.02) | 0.995  |
|  NOVEOS Specific IgE Assay, F001, Egg White  |   |   |   |   |
| --- | --- | --- | --- | --- |
|  Dilution Series | Dilution Range (kU/L) | Slope (95% CI) | Intercept (95% CI) | R²  |
|  1 | 0.14 - 3.73 | 1.05 (0.97 to 1.05) | -0.02 (-0.07 to 0.08) | 0.999  |
|  2 | 0.92 - 33.82 | 1.01 (0.99 to 1.02) | -0.18 (-0.41 to 0.04) | 1.000  |
|  3 | 3.40 - 105.97 | 1.01 (0.88 to 1.13) | 2.47 (-3.79 to 8.73) | 0.992  |
|  All | 0.14 - 105.97 | 1.01 (0.98 to 1.05) | -0.01 (-0.02 to 0.01) | 0.995  |

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|  NOVEOS Specific IgE Assay, F002, Cow’s Milk  |   |   |   |   |
| --- | --- | --- | --- | --- |
|  Dilution Series | Dilution Range (kU/L) | Slope (95% CI) | Intercept (95% CI) | R²  |
|  1 | 0.05 - 1.78 | 0.94 (0.85 to 1.02) | -0.01 (-0.02 to 0.00) | 0.993  |
|  2 | 0.78 - 45.83 | 1.08 (1.01 to 1.14) | -0.01 (-0.32 to 0.12) | 0.997  |
|  3 | 1.37 - 96.86 | 0.98 (0.95 to 1.01) | -0.26 (-0.42 to -0.11) | 0.999  |
|  All | 0.05 - 96.86 | 0.98 (0.94 to 1.01) | -0.01 (-0.02 to -0.00) | 0.995  |

## Endogenous Substance Interference

Interference testing by endogenous substances of NOVEOS sIgE allergens was carried out in accordance with CLSI guideline EP07, Interference Testing in Clinical Chemistry – Third Edition. The effect of the presence of elevated levels of human serum albumin, hemoglobin, triglyceride, conjugated bilirubin, and unconjugated bilirubin in serum samples was evaluated by testing three serum sample pools (one negative, one near the cut-off, and one positive) spiked with varying levels of each interferent. To mimic the dilution effect caused by the spiked interferent, the same amount of respective solvent was spiked into each of the sample pools and tested as control samples.

For NOVEOS sIgE allergens G010 (Johnson Grass), G002 (Bermuda Grass), F001 (Egg White), and F002 (Cow’s Milk), the samples were tested in replicates of 12 in one assay run with three different allergen lots. For NOVEOS sIgE allergens T007 (Oak), W001 (Common Ragweed), E005 (Dog Dander), and T003 (Common Silver Birch), the samples were tested in replicates of seven in one assay run with one lot of Capture Reagent.

The % recovery for each sample spiked with the potential interfering substance was calculated by comparing its result to that of the corresponding control sample. The substances listed in the table below show no significant interference at the indicated test concentrations for all allergens under evaluation.

|  Substance | Concentration  |
| --- | --- |
|  Hemoglobin | 200 mg/dL  |
|  Conjugated Bilirubin | 30 mg/dL  |
|  Unconjugated Bilirubin | 20 mg/dL  |
|  Intralipid | 3002 mg/dL  |
|  Human Serum Albumin | 120 g/L  |

Interference testing with rheumatoid factor (RF) was previously performed for NOVEOS sIgE allergens and found no significant interference at 513 IU/mL. For RF interference testing, refer to cleared 510(k) submissions K200825.

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# Exogenous Substance Interference

Interference testing with potentially interfering exogenous substances biotin, diphenhydramine, methylprednisolone, ranitidine, and omalizumab was previously performed for NOVEOS sIgE allergens and found no significant interference at the concentrations listed in the table below. Refer to previously cleared 510(k) submission K200825.

|  Substance | Concentration  |
| --- | --- |
|  Biotin | 3500 ng/mL  |
|  Diphenhydramine | 19.5 μmol/L  |
|  Methylprednisolone | 1000 ng/mL  |
|  Ranitidine | 19.1 μmol/L  |
|  Omalizumab | 0.12 mg/mL  |

# Cross-Reactivity

Cross-reactivity testing with other human immunoglobulins (IgA, IgD, IgG, and IgM) was previously performed for NOVEOS sIgE allergens that utilize the same universal anti-IgE conjugate reagent as those currently under evaluation and found no significant interference at physiological concentrations of IgA, IgG, IgM (14.86 mg/mL), and IgG (0.173 mg/mL). Refer to previously cleared 510(k) submission K200825.

# Competitive Inhibition (Analytical Specificity)

Immunological specificity of NOVEOS sIgE allergens was demonstrated through competitive inhibition in accordance with CLSI I/LA20-3rd Edition, Analytical Performance Characteristics, Quality Assurance, and Clinical Utility of Immunological Assays for Human Immunoglobulin E Antibodies of Defined Allergen Specificities.

For each NOVEOS sIgE allergen, a positive sample was tested with specific IgE concentrations shown in the table below:

|  NOVEOS sIgE Allergen | Concentration (kU/L)  |
| --- | --- |
|  G010, Johnson Grass | 1.52  |
|  T007, Oak | 12.12  |
|  G002, Bermuda Grass | 2.79  |
|  W001, Common Ragweed | 4.88  |
|  E005, Dog Dander | 3.65  |
|  T003, Common Silver Birch | 2.27  |
|  F001, Egg White | 2.04  |
|  F002, Cow’s Milk | 8.51  |

The allergen solution (inhibitor) was diluted 1:1 into the positive sample and subsequently

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serially diluted five times in two-fold increments. Each diluted sample was evaluated for dose-dependent inhibition in replicates of four using three lots of NOVEOS sIgE allergens G010 (Johnson Grass), G002 (Bermuda Grass), F001 (Egg White), and F002 (Cow's Milk), and one lot of NOVEOS sIgE allergens T007 (Oak), W001 (Common Ragweed), E005 (Dog Dander), and T003 (Common Silver Birch).

Related and unrelated allergen inhibitors were tested for each NOVEOS sIgE allergen in a single-dose competitive inhibition study. The related and unrelated allergen inhibitors were tested at a concentration at least 10 times the final concentration that achieved &gt;50% inhibition for the allergen under evaluation. The related and unrelated allergens used for each NOVEOS sIgE allergen are shown in the table below:

|  NOVEOS sIgE Allergen | Related Inhibitor | Unrelated Inhibitors  |
| --- | --- | --- |
|  G010, Johnson Grass | G006, Timothy Grass | • E085, Chicken Feathers
• F203, Pistachio Nut
• T008, Elm  |
|  T007, Oak | T006, Mountain Cedar | • E003, Horse Epithelia
• F004, Whole Wheat
• M003, Aspergillus fumigatus  |
|  G002, Bermuda Grass | G202, Maize, Corn | • F203, Pistachio Nut
• T008, Elm
• W001, Short Ragweed  |
|  W001, Common Ragweed | W014, Rough Redroot Pigweed | • E003, Horse Epithelia
• F004, Whole Wheat
• T003, White Birch  |
|  E005, Dog Dander | E003, Horse Epithelia | • M003, Aspergillus fumigatus
• T006, Mountain Cedar
• W006, Mugwort  |
|  T003, Common Silver Birch | T083, Mango Blossom | • E003, Horse Epithelia
• F202, Cashew Nut
• W006, Common Mugwort
• W012, Goldenrod
• W017, Firebush  |
|  F001, Egg White | F002, Cow's Milk | • G010, Johnson Grass
• M006, Alternaria alternata
• W006, Common Mugwort  |

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F002, Cow's Milk | F001, Egg White | • E085, Chicken Feathers<br/>• G002, Bermuda Grass<br/>• T008, Elm |

Inhibitor concentrations used for testing of the NOVEOS sIgE allergens are shown in the table below:

|  NOVEOS sIgE Allergen | Dose-Dependent Inhibition |   | Single-Dose Inhibition  |   |
| --- | --- | --- | --- | --- |
|   |  Highest Tested Inhibitor Conc. (μg/mL) | Final Conc. at >50% Inhibition (μg/mL) | Final Conc. of Related Inhibitor (μg/mL) | Final Conc. of Unrelated Inhibitors (μg/mL)  |
|  G010, Johnson Grass | 148.0 | 18.5 | 1480 | 1480  |
|  T007, Oak | 100 | 3.125 | 31.25 | 31.25  |
|  G002, Bermuda Grass | 285.5 | 17.8 | 2855 | 2855  |
|  W001, Common Ragweed | 3.125 | 0.78 | 7.8 | 7.8  |
|  E005, Dog Dander | 25 | 0.78 | 7.8 | 7.8  |
|  T003, Common Silver Birch | 100 | 6.25 | 62.5 | 62.5  |
|  F001, Egg White | 100 | 3.125 | 125 | 125  |
|  F002, Cow's Milk | 100 | 6.25 | 62.5 | 62.5  |

Greater than 50% inhibition was achieved in the dose-dependent inhibition studies and no inhibition was observed for the related and unrelated inhibitors for all NOVEOS sIgE allergens. The inhibition studies indicate that the NOVEOS sIgE allergens contain their respective immunologically relevant allergens.

## Detection Limit

Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantitation (LoQ) of NOVEOS sIgE allergens were estimated in accordance with CLSI guideline EP17-A2, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline – Second Edition.

## Limit of Blank

For G010, Johnson Grass; G002, Bermuda Grass; F001, Egg White; F002, Cow's Milk, the study was done by using three lots of capture reagent on three NOVEOS Immunoassay Analyzers. Five analyte-free human serum samples were tested in replicates of two per run, over six runs, with no more than one run per instrument per day, for a total of 60 replicates per lot.

For T007, Oak; W001, Common Ragweed; E005, Dog Dander; T003, Common Silver Birch, the study was done using two lots of capture reagent and one NOVEOS Immunoassay Analyzer. Four analyte-free human serum samples were tested in replicates of five per run, over three runs, with no more than one run per day, for a total of 60 replicates per lot.

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The value at the 95th percentile of the 60 measurements for each of the lots tested was estimated.

## Limit of Detection

LoD for each assay was determined by testing multiple human serum samples with low IgE concentrations using 2-3 lots of capture reagents and on NOVEOS Immunoassay Analyzers. The study protocol is summarized in the table below:

|  NOVEOS sIgE Assay | No. of Sample | No. of Lot | No. of Analyzer | Testing Protocol  |
| --- | --- | --- | --- | --- |
|  E005 | 5 | 2 | 1 | 5 samples x 5 replicates/run x 3 runs = 75/Lot  |
|  F001 | 4 | 3 | 2 | 4 samples x 10 replicates/run x 6 runs = 240/Lot  |
|  F002 | 4 | 3 | 2 | 4 samples x 10 replicates/run x 6 runs = 240/Lot  |
|  G002 | 5 | 3 | 3 | 5 samples x 10 replicates/run x 6 runs = 300/Lot  |
|  G010 | 5 | 3 | 3 | 5 samples x 10 replicates/run x 6 runs = 300/Lot  |
|  T003 | 5 | 2 | 2 | 5 samples x 5 replicates/run x 3 runs = 75/Lot  |
|  T007 | 4 | 2 | 2 | 4 samples x 5 replicates/run x 3 runs = 60/Lot  |
|  W010 | 4 | 2 | 1 | 4 samples x 5 replicates/run x 3 runs = 60/Lot  |

The LoD was calculated for each lot using a non-parametric analysis.

## Limit of Quantitation

LoQ was evaluated as a functional sensitivity-based approach with no bias component to LoQ. Functional sensitivity for NOVEOS sIgE allergens G010 (Johnson Grass), T007 (Oak), G002 (Bermuda Grass), W001 (Common Ragweed), E005 (Dog Dander), T003 (Common Silver Birch), F001 (Egg White), and F002 (Cow's Milk), was determined using a set of at least four samples with low IgE concentrations and two lots of NOVEOS sIgE allergen. The samples were tested with replicates of three, over at least three testing days resulting in a total of at least 36 replicates. Data analysis was performed according to the precision profile method using within-lab precision results. The LoQ is defined as the mean value of the lowest sample which fulfills the specification for the total within-laboratory imprecision (&lt;20%CV).

The claimed LoB, LoD, and LoQ are based on the highest value obtained from the lots tested and are summarized in the table below:

|  NOVEOS sIgE Allergen | LoB (kU/L) | LoD (kU/L) | LoQ (kU/L)  |
| --- | --- | --- | --- |
|  G010, Johnson Grass | 0.03 | 0.06 | 0.10  |
|  T007, Oak | 0.04 | 0.05 | 0.10  |
|  G002, Bermuda Grass | 0.03 | 0.05 | 0.10  |
|  W001, Common Ragweed | 0.03 | 0.05 | 0.10  |
|  E005, Dog Dander | 0.03 | 0.06 | 0.16  |
|  T003, Common Silver Birch | 0.04 | 0.08 | 0.10  |

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|  NOVEOS sIgE Allergen | LoB (kU/L) | LoD (kU/L) | LoQ (kU/L)  |
| --- | --- | --- | --- |
|  F001, Egg White | 0.02 | 0.04 | 0.14  |
|  F002, Cow’s Milk | 0.03 | 0.05 | 0.10  |

## Reference Range

The expected value is negative (&lt;0.35 kU/L) for a specific allergen in a non-atopic person. Each laboratory should establish its own expected value.

The expected value/reference range of NOVEOS sIgE assays for G010 (Johnson Grass), T007 (Oak), G002 (Bermuda Grass), W001 (Common Ragweed), E005 (Dog Dander), T003 (Common Silver Birch), F001 (Egg White), and F002 (Cow’s Milk) in a normal population was verified in accordance with CLSI EP28-A3c, *Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory – 3rd Edition*. The 95% reference range was calculated by ordering the dose recoveries from 121 to 137 non-atopic samples in ascending order of concentration and identifying the dose recovery that fell at the 95th percentile rank. The 95% reference range for each allergen under evaluation was below the established NOVEOS sIgE cutoff of 0.35 kU/L.

## Stability

### Shelf-Life Stability

Both an ongoing real-time stability study and an accelerated stability study were performed for NOVEOS sIgE assays for G010 (Johnson Grass), T007 (Oak), G002 (Bermuda Grass), W001 (Common Ragweed), E005 (Dog Dander), T003 (Common Silver Birch), F001 (Egg White), and F002 (Cow’s Milk) in accordance with CLSI EP25-A2 *Evaluation of Stability of In Vitro Diagnostic Reagents – First Edition*. The accelerated stability study and ongoing real-time stability study were performed with two positive and one negative sample using three lots of NOVEOS Allergen (Capture Reagent).

The accelerated stability data supports the manufacturer’s claim of up to 36-month unopened shelf-life stability for the capture reagents listed in the table below. Stability of common assay reagents (reagents except the Capture Reagent) has been established previously in prior submission K182479.

|   |   | Shelf-life Stability (2-8°C)  |
| --- | --- | --- |
|  Specific IgE Capture Reagent G010* |   | 36 months  |
|  Specific IgE Capture Reagent T007* |   | 36 months  |
|  Specific IgE Capture Reagent G002* |   | 36 months  |
|  Specific IgE Capture Reagent W001* |   | 9 months  |
|  Specific IgE Capture Reagent E005* |   | 36 months  |
|  Specific IgE Capture Reagent T003* |   | 36 months  |
|  Specific IgE Capture Reagent F001* |   | 36 months  |
|  Specific IgE Capture Reagent F002* |   | 28 months  |
|   | Diluent A | 48 months  |

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|   |   | Shelf-life Stability (2-8°C)  |
| --- | --- | --- |
|  IgE Common Kit | Conjugate IgE | 18 months  |
|   | Substrate A and Substrate B | 24 months  |
|   |  Fluo Beads™ | 24 months  |
|  IgE Calibrator Set |   | 24 months  |
|  Calibrator Antibody IgE |   | 24 months  |
|  Others | Probe Wash Pack | 24 months  |
|   |  Wash Buffer Concentrate | 48 months  |
|   |  Cuvette Wash Pack | 12 months  |
|  Controls | IgE Negative Control Pack | 48 months  |
|   |  IgE Positive Control Pack | 24 months  |
|  *Based on accelerated stability data  |   |   |

Real-time stability studies of the NOVEOS sIgE allergens are on-going to further support the manufacturer's claim of up to 36-months unopened shelf-life stability when stored at 2-8°C per the manufacturer's instructions for use.

## On-Board Stability (OBS)

Real-time OBS stability studies using three lots (per previous protocol) of NOVEOS sIgE allergens G010 (Johnson Grass), G002 (Bermuda Grass), F001 (Egg White), and F002 (Cow's Milk), and one lot (per updated protocol) of NOVEOS sIgE allergens T007 (Oak), W001 (Common Ragweed), E005 (Dog Dander), and T003 (Common Silver Birch), support the on-board stability claim of 15 days for capture reagents as summarized in the table below. The real-time on-board stability study was performed with at least 3 samples, including at least two positive samples and one negative or low-level sample using one lot of NOVEOS Allergen (Capture Reagent) stored on-board the instrument. OBS of common assay reagents (reagents except the Capture Reagent) has been established previously in prior submission K182479.

|   | On-board Stability (2-8°C)  |
| --- | --- |
|  Specific IgE Capture Reagent G010 | 15 days  |
|  Specific IgE Capture Reagent T007 | 15 days  |
|  Specific IgE Capture Reagent G002 | 15 days  |
|  Specific IgE Capture Reagent W001 | 15 days  |
|  Specific IgE Capture Reagent E005 | 15 days  |
|  Specific IgE Capture Reagent T003 | 15 days  |
|  Specific IgE Capture Reagent F001 | 15 days  |

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|   |   | On-board Stability (2-8°C)  |
| --- | --- | --- |
|  Specific IgE Capture Reagent F002 |   | 15 days  |
|  IgE Common Kit | Diluent A | 14 days  |
|   |  Conjugate IgE | 14 days  |
|   |  Substrate A and Substrate B | 14 days  |
|   |  Fluo Beads™ | 14 days  |
|  IgE Calibrator Set |   | 48 hours  |
|  Others | Probe Wash Pack | N/A  |
|   |  Wash Buffer Concentrate | 28 days  |
|   |  Cuvette Wash Pack | 28 days  |
|  Controls | IgE Negative Control Pack | 48 hours  |
|   |  IgE Positive Control Pack | 48 hours  |

# Open-Vial Stability (OVS)

Both an ongoing real-time stability study and an accelerated stability study were performed for the NOVEOS sIgE allergens in accordance with CLSI EP25-A Evaluation of Stability of In Vitro Diagnostic Reagents – First Edition. The accelerated stability data supports the manufacturer's claim of up to 365-day open-vial shelf-life stability for the individual assay components listed in the table below. OVS of common assay reagents (reagents except the Capture Reagent) has been established previously in prior submission K182479.

|   |   | Open-Vial Stability (2-8°C)  |
| --- | --- | --- |
|  Specific IgE Capture Reagent G010* |   | 365 days  |
|  Specific IgE Capture Reagent T007* |   | 365 days  |
|  Specific IgE Capture Reagent G002* |   | 365 days  |
|  Specific IgE Capture Reagent W001* |   | 365 days  |
|  Specific IgE Capture Reagent E005* |   | 365 days  |
|  Specific IgE Capture Reagent T003* |   | 365 days  |
|  Specific IgE Capture Reagent F001* |   | 365 days  |
|  Specific IgE Capture Reagent F002* |   | 365 days  |
|  IgE Common Kit | Diluent A | 28 days  |
|   | Conjugate IgE | 28 days  |
|   |  Substrate A and Substrate B | 28 days  |
|   |  Fluo Beads™ | 28 days  |

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|   |   | Open-Vial Stability (2-8°C)  |
| --- | --- | --- |
|  IgE Calibrator Set |   | N/A  |
|  Others | Probe Wash Pack | N/A  |
|   |  Wash Buffer Concentrate | 28 days (15 – 28°C)  |
|   |  Cuvette Wash Pack | 28 days (2 – 28°C)  |
|  Controls | IgE Negative Control Pack | N/A  |
|   |  IgE Positive Control Pack | N/A  |
|  *Based on accelerated stability data  |   |   |

Real-time stability studies of the NOVEOS sIgE allergens are on-going to further support the manufacturer's claim of up to 365-day open-vial shelf-life stability when stored per the manufacturer's instructions for use.

## Stored Calibration Curve

The stored calibration curve interval was established by testing the six NOVEOS IgE calibrators and serum samples against previously cleared representative allergens. The testing met the acceptance criteria and established the use of stored curve for up to 28 days.

## NOVEOS Software

Software testing up to version 1.1.0 was conducted, and documentation was provided per 2005 FDA Guidance- "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device is considered as a "Moderate" level of concern. Software standard - "IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical device software - Software life cycle processes" and risk management standard - "ISO 14971 Third Edition 2019-12, Medical devices - Application of risk management to medical devices" were also applied to the design.

## NOVEOS Cybersecurity

Patient safety, security, and privacy risks have been addressed in this submission including a Security Risk Assessment, Threat model, and Cybersecurity testing. This includes system necessary cybersecurity controls which address the general principles and security capabilities outlined in the 2023 FDA guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions". Additionally, in accordance with the FDA's Policy, Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&amp;C Act ", a plan to monitor, identify and address, in a reasonable time, post market vulnerabilities and exploits, and an SBOM is provided.

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## Proposed Labeling:
The labeling supports the finding of substantial equivalence for this device.

## Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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---

**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHB/K242531](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHB/K242531)

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