← Product Code [DHB](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHB) · K200825

# NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum pratense (K200825)

_Hycor Biomedical · DHB · Jun 26, 2020 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHB/K200825

## Device Facts

- **Applicant:** Hycor Biomedical
- **Product Code:** [DHB](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHB.md)
- **Decision Date:** Jun 26, 2020
- **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 performed on the NOVEOS Immunoassay Analyzer in clinical laboratories. It uses human serum samples to detect allergen-specific IgE. The assay employs fluorescent-labeled, streptavidin-coated magnetic microparticles incubated with a biotinylated allergenic capture reagent, the patient sample, and a horseradish peroxidase-conjugated monoclonal anti-human IgE antibody. After washing, an enzyme substrate is added to generate a chemiluminescent signal proportional to the IgE concentration. Results are calculated against a standard curve traceable to WHO reference reagent 11/234. Healthcare providers use these quantitative results, alongside clinical history and other findings, to diagnose IgE-mediated allergic disorders. The device provides a standardized, automated method for allergy testing, potentially improving diagnostic accuracy and efficiency compared to manual or less sensitive methods.

## Clinical Evidence

Clinical performance was evaluated by comparing NOVEOS sIgE results to allergic status (confirmed by skin-prick testing and clinical history) in 200 samples for Cat Dander (E001) and 188 samples for Timothy Grass (G006). For E001, clinical sensitivity was 75.7% and specificity was 100%. For G006, clinical sensitivity was 76.2% and specificity was 99.2%. Method comparison studies against the predicate ImmunoCAP showed high agreement (PPA 91.8% for E001; 86.4% for G006). Analytical performance included imprecision (total CV <12%), linearity (R2 >0.99), and interference testing showing <15% interference for common substances.

## Technological Characteristics

Immunometric, chemiluminescent assay using fluorescent-labeled magnetic microparticles. Energy source: NOVEOS Immunoassay Analyzer. Dimensions/form factor: Liquid ready-to-use reagents. Connectivity: Integrated with NOVEOS Immunoassay Analyzer. Calibration: 6-level heterologous interpolation. Traceability: WHO reference reagent 11/234. Reaction temperature: 37°C.

## 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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FDA

U.S. FOOD &amp; DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K200825

B Applicant

Hycor Biomedical

C Proprietary and Established Names

NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus
NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass - G006, Phleum pratense

D Regulatory Information

|  Product Code(s) | Classification | Regulation Section | Panel  |
| --- | --- | --- | --- |
|  DHB | Class II | 21 CFR 866.5750 - Radioallergosorbent (Rast) Immunological Test System | IM - Immunology  |

## II Submission/Device Overview:

A Purpose for Submission:

Two new devices

B Measurand:

Allergen specific IgE to Cat Dander E001, Felis domesticus
Allergen specific IgE to Timothy Grass G006, Phleum pratense

C Type of Test:

Chemiluminescent, Quantitative

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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K200825 - Page 2 of 16

## III Intended Use/Indications for Use:

### A Intended Use(s):

See Indications for Use below.

### B Indication(s) for 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.

### C Special Conditions for Use Statement(s):

Rx - For Prescription Use Only

### D Special Instrument Requirements:

For use on the NOVEOS Immunoassay Analyzer

## IV Device/System Characteristics:

### A Device Description:

The NOVEOS specific IgE (sIgE) Assay consists of the following reagents:

- IgE Common Kit:
- Diluent A (human serum albumin in buffer with preservative)
- Conjugate IgE (horse radish peroxidase labeled mouse monoclonal anti-IgE antibody with preservative)
- Substrate A
- Substrate B
- Fluo Beads (streptavidin coated magnetic particles with preservative)

- Capture Reagent Pack
- Cat Dander E001, Felis domesticus
- Timothy Grass G006, Phleum pretense

- IgE Calibrator Set (six levels: 0.07, 0.35, 0.70, 3.5, 17.5, 100 kU/L)
- IgE Calibrator Antibody Pack (mouse monoclonal anti-human IgE with preservative)
- IgE Positive Control Pack (known to be &gt;0.35 kU/L)
- IgE Negative Control Packs (known to be &lt;0.35 kU/L)

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- Others:
- Probe Wash Pack (phosphate buffered citric acid solution with preservative)
- Wash Buffer Concentrate Pack (10X phosphate buffer saline solution with preservative)
- Cuvette Wash Pack (citric acid solution with preservative)

The NOVEOS Immunoassay Analyzer is a high-throughput, highly automated immunoassay platform that employs magnetic microbeads as the solid phase. The immunoassay reaction takes place in individual reaction chambers in the reaction rotor, with other rotors containing patient samples and reagents. Liquids are moved by robotic pipettors. The reaction is quantitated by a combination of chemiluminescence and fluorescence measurements compared to a calibration curve, all performed by the analyzer with the NOVEOS software.

## B Principle of Operation:

The NOVEOS specific IgE (sIgE) Assay is an immunometric, chemiluminescent assay for the quantitative determination of IgE of known specificity in human serum samples. Magnetic beads coated with streptavidin and fluorescent dye are incubated with a biotinylated allergen that binds to the streptavidin molecule on the surface of the beads. The beads are collected by use of a magnetic field to remove the liquid, and then undergo a wash step to remove unbound biotinylated allergen prior to incubation with the sample. If present in the sample, sIgE binds to the captured biotinylated allergen. After incubation, the beads are washed and subsequently incubated with an HRP-labeled anti-IgE monoclonal antibody (Conjugate IgE) to form an antibody-conjugate complex that is bound to the captured biotinylated allergen. After washing away the non-bound conjugate, a chemiluminescent substrate is added to the assay mixture resulting in light generation in proportion to the amount of antibody-conjugate that has been bound to the beads. The fluorescence is used to correct for any bead loss during the assay, and the (corrected) chemiluminescence is compared to a calibration curve to provide quantification of bound sIgE. The higher the value of chemilumiscent signal detected by the instrument, the higher the amount of sIgE detected in the sample tested.

## V Substantial Equivalence Information:

### A Predicate Device Name(s):

ImmunoCAP Specific IgE Assay and ImmunoCAP Specific IgE Conjugate 100 and Conjugate 400

### B Predicate 510(k) Number(s):

K051218

### C Comparison with Predicate(s):

K200825 - Page 3 of 16

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K200825 - Page 4 of 16
|  Device & Predicate Device(s): | K200825 | K051218  |
| --- | --- | --- |
|  Device Trade Name | NOVEOS sIgE Assay | ImmunoCAP Specific IgE  |
|  General Device Characteristic Similarities |  |   |
|  Intended Use/Indications For 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 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.  |
|  Assay Type | Quantitative | Same  |
|  Allergen | Whole extract of allergen material:
• Cat Dander E001, Felis domesticus
• Timothy Grass G006, Phleum pratense | Same  |
|  Traceability | World Health Organization (WHO) reference reagent serum Immunoglobulin E (IgE) 11/234 | Same  |
|  Number of Calibrators | Six | Same  |
|  Reaction Temperature | 37 °C | Same  |
|  General Device Characteristic Differences |  |   |
|  Specimen Type | Serum | Serum and Plasma (EDTA, Na-Heparin)  |
|  Solid Phase | Magnetic microparticles | Cellulose derivative  |
|  Instrument(s) | NOVEOS Immunoassay Analyzer | Phadia 100, Phadia 250/1000/2500/5000  |

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|  Assay Principle | Chemiluminescent assay | Fluoroenzyme-immunoassay  |
| --- | --- | --- |
|  General Device Characteristic Differences |  |   |
|  Detection Antibody | HRP conjugated mouse anti-human IgE monoclonal antibody | β-Galactosidase conjugated mouse anti-human IgE monoclonal antibody  |
|  Sample Volume | 4 μL | 40 μL  |
|  Detection Limit | E001:
LoB: 0.02 kU/L
LoD: 0.06 kU/L
LoQ: 0.14 kU/L
G006:
LoB: 0.03 kU/L
LoD: 0.06 kU/L
LoQ: 0.14 kU/L | LoB: 0.001 kU/L
LoD: 0.02 kU/L
LoQ: 0.10 kU/L  |
|  Assay Range | 0.17 – 100 kU/L | 0.10 – 100 kU/L  |
|  Assay Duration | 1 hour and 45 minutes | Phadia 100: 2 hours and 30 minutes
Phadia 250/1000/2500/5000: 1 hour and 45 minutes from entering the first sample  |

VI Standards/Guidance Documents Referenced:

- CLSI I/LA20-A3, Performance Characteristics, Quality Assurance, and Clinical Utility of Immunological Assays for Human Immunoglobulin E Antibodies and Defined Allergen Specificities, Approved Guideline–Third Edition
- CLSI EP05-A3, Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline–Third Edition.
- CLSI EP17-A2, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline – Second Edition
- CLSI EP6-A, Evaluation of Linearity of Quantitative Measurement, Approved Guideline
- CLSI EP25-A, Evaluation of Stability of In Vitro Diagnostic Reagents, Approved Guideline – Second Edition
- CLSI EP07-A2, Interference Testing in Clinical Chemistry; Approved Guideline – Second Edition
- CLSI EP15-A3, User Verification of Precision and Estimation of Bias; Approved Guideline - Third Edition
- CLSI EP28-A3c, Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline – Third Edition

VII Performance Characteristics (if/when applicable):

A Analytical Performance:

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All results presented below met the manufacturer's pre-determined acceptance criteria.

1. Precision/Reproducibility:

i) Within-laboratory imprecision

A study was conducted per CLSI guideline EP05-A3 to evaluate the imprecision of the NOVEOS sIgE Assay, E001 and the NOVEOS sIgE Assay, G006. Two separate panels, one consisting of five samples (one negative and two positive human serum samples for E001 plus two controls) and the other consisting of six samples (one negative and three positive human serum samples for G006 plus two controls), were tested at one site, in two replicates per run, two runs per day for 20 days using one reagent lot on one NOVEOS Immunoassay Analyzer (for a total of 80 measurements per sample). The standard deviation (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 tables:

|  NOVEOS sIgE Assay, E001  |   |   |   |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Sample | Mean (kU/L) | Within-Run |   | Between-Run |   | Between-Day |   | Total  |   |
|   |   |  SD (kU/L) | CV (%) | SD (kU/L) | CV (%) | SD (kU/L) | CV (%) | SD (kU/L) | CV (%)  |
|  LoQ18 | 0.26 | 0.02 | 7.1 | 0.01 | 5.0 | 0.02 | 5.9 | 0.03 | 10.5  |
|  PP46 | 8.63 | 0.31 | 3.6 | 0.18 | 2.1 | 0.49 | 5.7 | 0.61 | 7.0  |
|  LYP | 12.59 | 0.45 | 3.6 | 0.63 | 5.0 | 0.67 | 5.3 | 1.02 | 8.1  |
|  NOV | 13.62 | 0.59 | 4.3 | 0.68 | 5.0 | 0.82 | 6.0 | 1.22 | 8.9  |
|  PP28 | 40.81 | 1.37 | 3.4 | 1.67 | 4.1 | 2.47 | 6.0 | 3.28 | 8.0  |
|  LYP: Lyphochek Positive Control Sample
NOV: NOVEOS Positive Control Sample  |   |   |   |   |   |   |   |   |   |
|  NOVEOS sIgE Assay, G006  |   |   |   |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Sample | Mean (kU/L) | Within-Run |   | Between-Run |   | Between-Day |   | Total  |   |
|   |   |  SD (kU/L) | CV (%) | SD (kU/L) | CV (%) | SD (kU/L) | CV (%) | SD (kU/L) | CV (%)  |
|  LoQ50 | 0.19 | 0.01 | 7.0 | 0.01 | 7.1 | 0.01 | 3.2 | 0.02 | 10.4  |
|  PP48 | 0.37 | 0.01 | 4.0 | 0.01 | 3.9 | 0.01 | 3.1 | 0.02 | 6.4  |
|  PP25 | 6.36 | 0.19 | 3.0 | 0.21 | 3.3 | 0.15 | 2.4 | 0.32 | 5.0  |
|  LYP | 8.86 | 0.24 | 2.7 | 0.40 | 4.5 | 0.38 | 4.3 | 0.60 | 6.8  |
|  NOV | 27.50 | 1.15 | 4.2 | 1.86 | 6.8 | 2.13 | 7.7 | 3.05 | 11.1  |
|  PP06 | 44.04 | 2.01 | 4.6 | 2.19 | 5.0 | 3.72 | 8.4 | 4.76 | 10.8  |
|  LYP: Lyphochek Positive Control Sample
NOV: NOVEOS Positive Control Sample  |   |   |   |   |   |   |   |   |   |

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ii) Lot-to-lot imprecision:

The same two sample panels used in the within-laboratory precision study were also tested on two additional different lots of the respective NOVEOS sIgE Assay for a total of three reagent lots. Each sample was tested in two replicates per run, two runs per day for 20 days. The lot-to-lot imprecision was evaluated based on a total of 240 measurements per sample. The results are summarized in the following tables:

|  NOVEOS sIgE Assay, E001  |   |   |   |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Sample | Mean (kU/L) | Within-Run |   | Between-Day |   | Between-Lot |   | Total  |   |
|   |   |  SD (kU/L) | CV (%) | SD (kU/L) | CV (%) | SD (kU/L) | CV (%) | SD (kU/L) | CV (%)  |
|  LoQ18 | 0.26 | 0.02 | 6.5 | 0.01 | 5.2 | 0.00 | 0.0 | 0.03 | 9.5  |
|  PP46 | 8.51 | 0.30 | 3.5 | 0.51 | 5.9 | 0.10 | 1.2 | 0.65 | 7.6  |
|  LYP | 12.66 | 0.47 | 3.7 | 0.79 | 6.3 | 0.15 | 1.2 | 1.12 | 8.8  |
|  NOV | 13.65 | 0.54 | 4.0 | 0.78 | 5.7 | 0.00 | 0.0 | 1.26 | 9.2  |
|  PP28 | 41.07 | 1.53 | 3.7 | 2.56 | 6.2 | 0.48 | 1.2 | 3.35 | 8.2  |
|  LYP: Lyphochek Positive Control Sample
NOV: NOVEOS Positive Control Sample  |   |   |   |   |   |   |   |   |   |
|  NOVEOS sIgE Assay, G006  |   |   |   |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Sample | Mean (kU/L) | Within-Run |   | Between-Day |   | Between-Lot |   | Total  |   |
|   |   |  SD (kU/L) | CV (%) | SD (kU/L) | CV (%) | SD (kU/L) | CV (%) | SD (kU/L) | CV (%)  |
|  LoQ50 | 0.20 | 0.01 | 7.2 | 0.01 | 3.6 | 0.00 | 1.9 | 0.02 | 10.6  |
|  PP48 | 0.37 | 0.02 | 4.1 | 0.01 | 3.7 | 0.01 | 2.8 | 0.03 | 7.2  |
|  PP25 | 6.32 | 0.21 | 3.3 | 0.06 | 1.0 | 0.06 | 1.0 | 0.33 | 5.2  |
|  LYP | 8.83 | 0.29 | 3.3 | 0.48 | 5.4 | 0.14 | 1.6 | 0.69 | 7.8  |
|  NOV | 28.05 | 1.21 | 4.3 | 2.08 | 7.4 | 0.08 | 0.3 | 3.14 | 11.2  |
|  PP06 | 45.34 | 1.95 | 4.3 | 3.47 | 7.7 | 1.88 | 4.2 | 4.94 | 10.9  |
|  LYP: Lyphochek Positive Control Sample
NOV: NOVEOS Positive Control Sample  |   |   |   |   |   |   |   |   |   |

iii) Site-to-site reproducibility:

Reproducibility of the NOVEOS sIgE Assay, E001 and the NOVEOS sIgE Assay, G006 was evaluated by testing two separate six-member panels, one consisting of one negative and three positive human serum samples for E001 plus two controls and another consisting of one positive and three negative serum samples for G006 plus two controls, at three sites using the same lot of reagent. Each sample was tested in five replicates per run, one run per day for five days on one NOVEOS Immunoassay Analyzer at each site (for a total of 75 measurements per sample at all three sites). The results are summarized in the following tables:

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|  NOVEOS sIgE Assay, E001  |   |   |   |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Sample | Mean (kU/L) | Within-Run |   | Between-Day |   | Between-Site |   | Total  |   |
|   |   |  SD (kU/L) | CV (%) | SD (kU/L) | CV (%) | SD (kU/L) | CV (%) | SD (kU/L) | CV (%)  |
|  PP61 | 0.27 | 0.02 | 7.4 | 0.01 | 3.7 | 0.03 | 11.1 | 0.03 | 11.1  |
|  PP62 | 0.50 | 0.03 | 6.0 | 0.01 | 2.0 | 0.06 | 11.9 | 0.07 | 13.9  |
|  PP63 | 1.15 | 0.07 | 6.1 | 0.02 | 1.7 | 0.11 | 9.6 | 0.13 | 11.3  |
|  NOV | 10.64 | 0.56 | 5.3 | 0.22 | 2.1 | 0.46 | 4.3 | 0.76 | 7.1  |
|  LYP | 12.58 | 0.52 | 4.1 | 0.22 | 1.7 | 0.32 | 2.5 | 0.65 | 5.2  |
|  PP64 | 69.93 | 4.90 | 7.0 | 2.01 | 2.9 | 1.83 | 2.6 | 5.60 | 8.0  |
|  LYP: Lyphochek Positive Control Sample
NOV: NOVEOS Positive Control Sample  |   |   |   |   |   |   |   |   |   |
|  NOVEOS sIgE Assay, G006  |   |   |   |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Sample | Mean (kU/L) | Within-Run |   | Between-Day |   | Between-Site |   | Total  |   |
|   |   |  SD (kU/L) | CV (%) | SD (kU/L) | CV (%) | SD (kU/L) | CV (%) | SD (kU/L) | CV (%)  |
|  PP65* | 0.18 | 0.02 | 11.1 | 0.00 | 0.0 | 0.00 | 0.0 | 0.02 | 11.1  |
|  PP66 | 0.42 | 0.03 | 7.1 | 0.00 | 0.0 | 0.02 | 4.7 | 0.04 | 9.5  |
|  PP67 | 2.16 | 0.10 | 4.6 | 0.06 | 2.8 | 0.14 | 6.5 | 0.18 | 8.3  |
|  LYP | 8.46 | 0.36 | 4.3 | 0.25 | 3.0 | 0.26 | 3.1 | 0.51 | 6.0  |
|  NOV | 10.32 | 0.53 | 5.1 | 0.27 | 2.6 | 0.48 | 4.6 | 0.76 | 7.4  |
|  PP68 | 57.38 | 4.02 | 7.0 | 0.76 | 1.3 | 2.03 | 3.5 | 4.56 | 7.9  |
|  LYP: Lyphochek Positive Control Sample
NOV: NOVEOS Positive Control Sample
*One result was excluded from the final analysis dataset. The test result had an error flag for insufficient sample volume that was attributed to a bubble; the test was not repeated.  |   |   |   |   |   |   |   |   |   |

2. Linearity:

Linearity of each NOVEOS sIgE Assay was evaluated following CLSI guideline EP6-A by preparing three sets of dilution panel. Three positive serum samples (low, medium and high level) were each serially diluted in a two-fold scheme with a negative serum pool generating at least five consecutive dilutions. Each diluted sample was tested in replicates of five and each neat sample was tested in replicates of 15, all within one assay run using one reagent lot on one NOVEOS Immunoassay Analyzer. Results of the replicates for all three samples were analyzed for linearity. Regression statistics comparing the observed results (y) to expected results (x) of all samples in each and all three dilution panels are presented in the tables below.

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|  NOVEOS sIgE Assay, E001  |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- |
|  Dilution Series | Dilution Range (kU/L) | Regression Equation | Slope (95% CI) | Intercept (95% CI) | R²  |
|  1 | 0.03–4.90 | y = 1.00x - 0.04 | 0.99 - 1.02 | -0.08 - 0.00 | 1.000  |
|  2 | 0.03–49.36 | y = 1.01x - 0.34 | 0.97 - 1.05 | -1.17 - 0.49 | 0.999  |
|  3 | 0.03–101.62 | y = 1.01x - 1.11 | 0.97 -1.04 | -2.52 - 0.30 | 0.999  |
|  All | 0.03–101.62 | y = 1.00x - 0.37 | 0.98 - 1.01 | -0.79 - 0.05 | 0.999  |
|  NOVEOS sIgE Assay, G006  |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- |
|  Dilution Series | Dilution Range (kU/L) | Regression Equation | Slope (95% CI) | Intercept (95% CI) | R²  |
|  1 | 0.06–5.35 | y = 1.01x + 0.00 | 0.97 – 1.06 | -0.11 – 0.11 | 0.999  |
|  2 | 0.06–34.50 | y = 0.99x – 0.03 | 0.96 – 1.02 | -0.49 – 0.43 | 0.999  |
|  3 | 0.06–104.99 | y = 1.00x + 2.75 | 0.93 – 1.07 | -0.46 – 5.97 | 0.996  |
|  All | 0.06–104.99 | y = 1.02x + 0.58 | 0.99 – 1.05 | -0.36 – 1.51 | 0.997  |

The data summarized in the tables above support linearity throughout the claimed measuring range from 0.17 kU/L to 100 kU/L for both the NOVEOS sIgE Assay, E001 and NOVEOS sIgE Assay, G006.

## 3. Analytical Specificity/Interference:

### a) Inhibition study:

Immunological specificity of E001 (Cat Dander, *Felis domesticus*) and G006 (Timothy Grass, *Phleum pretense*) allergens was verified through competitive inhibition according to CLSI guideline I/LA20-A3. A positive sample with specific IgE concentration of ~7.6 kU/L for E001 and ~0.6 kU/L for G006 was used in the inhibition studies. The allergen solution (inhibitor) was diluted into the positive serum sample to achieve a starting concentration of 15 µg/mL for E001 and 50 µg/mL for G006. The sample solution was serially diluted five times in two-fold increments and each diluted sample was evaluated for dose-dependent inhibition in five replicates with one lot of reagent. The results of the dose-dependent inhibition study showed that &gt;50% inhibition was achieved with E001 and G006 at a final inhibitor concentration of 15 µg/mL and 25 µg/mL, respectively.

For the NOVEOS sIgE Assay, E001, the related allergen E006 (guinea pig epithelia, *Cavia porcellus*), and the unrelated allergens, G013 (velvet grass, *Holcus lanatus*), W011 (Russian thistle, *Salsola kali*) and M004 (*Mucor circinelloides f. lusitanicus*) were tested as potential inhibitors for at a final concentration of at least ten times the concentration of E001 at which &gt;50% inhibition was achieved. All allergen inhibitors were spiked into the positive serum sample at a 1:1 dilution and evaluated with three lots of NOVEOS sIgE Assay, E001. The results of the single-dose inhibition studies using one related allergen (E006) and three unrelated allergens (G013, W011 and M004) did not show inhibition at a test concentration of 150 µg/mL for the related allergen and 150 µg/mL for the three unrelated allergens. The inhibition studies indicate that the NOVEOS sIgE Assay, E001 contains the immunologically relevant allergen.

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For the NOVEOS sIgE Assay, G006, the related allergen G202 (cultivated corn, Zia mays), and the unrelated allergens, W043 (common sagebrush, Artemisia tridentata), F018 (brazil nut, Bertholletia excelsa) and M004 (Mucor circinelloides f. lusitanicus) were tested as potential inhibitors at a final concentration of at least ten times the concentration of G006 at which &gt;50% inhibition was achieved. All allergen inhibitors were spiked into the positive serum sample at a 1:1 dilution and evaluated with three lots of NOVEOS sIgE Assay, G006. The results of the single-dose inhibition studies using one related allergen (G202) and three unrelated allergens (W043, F018 and M004) did not show inhibition at a test concentration of 250 µg/mL for the related allergen and 250 µg/mL for the three unrelated allergens. The inhibition studies indicate that the NOVEOS sIgE Assay, G006 contains the immunologically relevant allergen.

b) Interference:

(1) Endogenous Substance Interference:

The effect of the presence of elevated level of human albumin, hemoglobin, triglyceride, conjugated bilirubin, unconjugated bilirubin, and rheumatoid factor in serum samples was evaluated by testing three (one negative, one near the cut-off and one positive) serum sample pools spiked with varying levels of each interferent and analyzed in 12 replicates in one assay run with three lots of each NOVEOS sIgE Assay. The % recovery for each sample spiked with the potential interfering substance was calculated by comparing its result to that of the corresponding reference sample spiked with an equal volume of the solvent without the interfering substance. No interference was noted for samples containing human serum albumin up to 120 g/L, hemoglobin up to 200 mg/dL, intralipid up to 3000 mg/dL, conjugated bilirubin up to 30 mg/dL, unconjugated bilirubin up to 20 mg/dL, and rheumatoid factor up to 513 IU/mL.

(2) Exogenous Substance Interference:

The same protocol used in the endogenous substance interference study was used to evaluate potentially interfering exogenous substances. No interference was noted for samples containing biotin at a concentration of 3500 ng/mL, diphenhydramine at 19.6 µmol/L, methylprednisolone at 1000 ng/mL, omalizumab at 0.12 mg/mL and ranitidine at 19.1 µmol/L.

c) Cross-reactivity:

The potential cross-reactivity of non-IgE (IgA, IgD, IgG, and IgM) to the NOVEOS sIgE Assay, E001 and NOVEOS sIgE Assay, G006 was evaluated by testing two separate panel, one consisting of three human serum samples (one negative and two positives including one near 0.35 kU/L for E001) and another consisting of five human serum samples (one negative and four positives including one near 0.35 kU/L for G006). Each serum sample was spiked with the immunoglobulin stock solutions containing IgA, IgG, and IgM (IgGAM) at 76.86 mg/mL and IgD at 77.25 mg/mL. The control samples were prepared by adding a solvent to mimic the IgGAM and IgD spiked volumes. Test and control samples were analyzed in replicates of three in one assay run with one lot of the reagent. The % recovery was calculated by comparing measurements of the test and

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control samples. No cross reactivity was noted up to 14.86 mg/mL for IgGAM and up to 0.173 mg/mL for IgD.

## 4. Assay Reportable Range:

The claimed measuring range is from 0.17 kU/L to 100 kU/L.

## 5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):

a) Traceability:

The IgE calibrators are traceable to the World Health Organization (WHO) third International Standard 11/234 of Human Serum Immunoglobulin E.

b) Kit Stability:

Shelf life stability: Both an ongoing real-time stability study and an accelerated stability study were performed in accordance with CLSI EP25-A using three lots of the NOVEOS E001 Capture Reagent and three lots of the NOVEOS G006 Capture Reagent. The accelerated stability data support the manufacturer's claim of 24-month unopened shelf-life stability for both the NOVEOS E001 Capture Reagent and NOVEOS G006 Capture Reagent. The real-time stability study is on-going and available data supports 16 months unopened shelf-life stability for both the NOVEOS E001 Capture Reagent and NOVEOS G006 Capture Reagent when stored at 2–8 °C per the manufacturer's instruction for use. All other reagents required to perform specific IgE testing on the NOVEOS system are not allergen specific and the shelf-life stability of these reagents has been previously established per K182479, with the exception of the Fluo Beads reagent which has an extended shelf-life stability of up to 24 months based on the real-time stability data per K191510. The claimed shelf-life for individual assay components is listed in the table below:

|   |   | Shelf-life Stability (2–8 °C)  |
| --- | --- | --- |
|  Specific IgE Capture Reagent E001* |   | 24 months  |
|  Specific IgE Capture Reagent G006* |   | 24 months  |
|  IgE Common Kit | Diluent A | 48 months  |
|   |  Conjugate IgE | 18 months  |
|   |  Substrate A and B | 24 months  |
|   |  Fluo Beads | 24 months  |
|  IgE Calibrator Set |   | 24 months  |
|  Calibrator Antibody IgE |   | 24 months  |
|  Controls | IgE Positive Control Pack | 24 months  |
|   |  IgE Negative Control Pack | 48 months  |
|  Others | Wash Buffer Concentrate | 48 months  |
|   |  Cuvette Wash Pack | 24 months  |
|   |  Probe Wash Pack | 24 months  |
|  *Results based on accelerated stability data  |   |   |

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On-board stability: A real-time stability study using three lots of the NOVEOS E001 Capture Reagent and three lots of the NOVEOS G006 Capture Reagent supports the on-board stability claim 28 days. The on-board stability for all the other assay components has been previously established per K182479 and are summarized in the table below.

|   |   | On-board Stability (2–8°C)  |
| --- | --- | --- |
|  Specific IgE Capture Reagent E001 |   | 28 days  |
|  Specific IgE Capture Reagent G006 |   | 28 days  |
|  IgE Common Kit | Diluent A | 14 days  |
|   |  Conjugate IgE | 14 days  |
|   |  Substrate A and B | 14 days  |
|   |  Fluo Beads | 14 days  |
|  IgE Calibrator Set |   | 48 hours  |
|  Controls | IgE Positive Control Pack | 48 hours  |
|   |  IgE Negative Control Pack | 48 hours  |
|  Others | 1x Wash Buffer | 28 days  |
|   |  Cuvette Wash Pack | 28 days  |
|   |  Probe Wash Pack | Not applicable  |

6. Detection Limit:

The limit of blank (LoB), limit of detection (LoD), and limit of Quantitation (LoQ) of the NOVEOS sIgE Assay, E001 and the NOVEOS sIgE Assay, G006 on the NOVEOS Immunoassay Analyzer were determined according to CLSI guideline EP17-A2.

LoB was determined by testing five IgE-free human serum samples in two replicates per run, one run per day, for six days using three lots of each NOVEOS sIgE Assay. The runs were spread out on three different NOVEOS Immunoassay Analyzers. The LoB was estimated as the 95th percentile of 60 measurements for each of the lots tested.

LoD was determined using five serum samples with low IgE concentrations with the NOVEOS sIgE Assay, E001 and six serum samples with low IgE concentrations with the NOVEOS sIgE Assay, G006. Each sample was tested in replicates of 10 replicates per run, one run per day, for six days using three lots of each NOVEOS sIgE Assay. The runs were spread out on three different NOVEOS Immunoassay Analyzers. The LoD was determined for each lot based on 300 measurements for E001 or 360 measurements for G006 as the mean concentration of the lowest sample with 95% or more of its replicates recovering above the LoB.

LoQ was determined as functional sensitivity using a set of five samples with low IgE concentrations. Each sample was tested in duplicates per run, two runs per day for 20 days with three lots of each NOVEOS sIgE Assay on one instrument for a total of 80 data points per sample per reagent lot. The LoQ is defined as the mean value of the sample which fulfills the specification for the total within-laboratory imprecision (&lt;20%CV).

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

|   | LoB | LoD | LoQ  |
| --- | --- | --- | --- |
|  NOVEOS sIgE Assay, E001 | 0.02 kU/L | 0.06 kU/L | 0.14 kU/L  |
|  NOVEOS sIgE Assay, G006 | 0.03 kU/L | 0.06 kU/L | 0.14 kU/L  |

# 7. Assay Cut-Off:

See clinical cut-off

# 8. Accuracy (Instrument):

Not applicable

# 9. Carry-Over:

Evaluation of instrument carryover was conducted using one lot of reagent of each NOVEOS sIgE Assay on three NOVEOS Immunoassay Analyzers. The carryover assessment is based on five cycle counts per instrument. Pooled high-level patient samples with sIgE concentrations ranging from 99.1 to  $100.0\mathrm{kU / L}$  for E001 and from 81.2 to 89.8 for G006 were aliquoted into five tubes and the pooled low-patient samples with sIgE concentrations of 0.04 and  $0.05\mathrm{kU / L}$  for E001 and of 0.05 and  $0.06\mathrm{kU / L}$  for G006, were aliquoted into 25 tubes. Each cycle consists of one high sample test followed by five low sample tests against the E001 or G006 capture reagent. Low Sample 1 following High Sample is denoted as "possibly affected" which has the highest chance of potential carryover thus leading to signal change  $&gt;0.10\mathrm{kU / L}$ . Low Samples 3-5 is denoted as "very probably unaffected" and therefore should not have elevated  $\mathrm{kU / L}$  signal. Carryover assessment is done by measuring the change  $(\Delta)$  of [mean concentration of Low Sample 1] and [mean concentration of Low Samples 3-5]. The results are summarized in the tables below:

|  NOVEOS sIgE Assay, E001  |   |   |   |   |
| --- | --- | --- | --- | --- |
|  NOVEOS Immunoassay Analyzer | Mean Conc. of High Sample (kU/L) | Mean Conc. of Low Sample 1 (kU/L) | Mean Conc. of Low Sample 3-5 (kU/L) | Δ Carryover (kU/L)  |
|  1 | 99.15 | 0.04 | 0.03 | 0.01  |
|  2 | 99.23 | 0.04 | 0.03 | 0.01  |
|  3 | 100.04 | 0.05 | 0.06 | -0.01  |
|  NOVEOS sIgE Assay, G006  |   |   |   |   |
| --- | --- | --- | --- | --- |
|  NOVEOS Immunoassay Analyzer | Mean Conc. of High Sample (kU/L) | Mean Conc. of Low Sample 1 (kU/L) | Mean Conc. of Low Sample 3-5 (kU/L) | Δ Carryover (kU/L)  |
|  1 | 81.19 | 0.06 | 0.05 | 0.01  |
|  2 | 82.38 | 0.06 | 0.05 | 0.01  |
|  3 | 89.84 | 0.05 | 0.05 | 0.00  |

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B Comparison Studies:

1. Method Comparison with Predicate Devices:

At least 200 serum samples spanning the measuring range were tested with each NOVEOS sIgE Assay (candidate) and the respective ImmunoCAP Specific IgE (predicate). Agreement between the candidate and predicate devices was evaluated using a clinical cut-off value of 0.35 kU/L. The results are summarized in the following tables:

|   | ImmunoCAP sIgE, Allergen e1, Cat dander  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Positive | Negative | Total  |
|  NOVEOS sIgE Assay, E001 | Positive | 89 | 2 | 91  |
|   |  Negative | 8 | 143 | 151  |
|   |  Total | 97 | 145 | 242  |
|   |  Positive Agreement: 91.8% (89/97) 95% CI: 84.6% – 95.8%
Negative Agreement: 98.6% (143/145) 95% CI: 95.1% – 99.6%
Total Agreement: 95.9% (232/242) 95% CI: 92.6% – 97.7%  |   |   |   |
|   | ImmunoCAP sIgE, Allergen g6, Timothy  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Positive | Negative | Total  |
|  NOVEOS sIgE Assay, G006 | Positive | 89 | 4 | 93  |
|   |  Negative | 14 | 131 | 145  |
|   |  Total | 103 | 135 | 238  |
|   |  Positive Agreement: 86.4% (89/103) 95% CI: 78.5% – 91.7%
Negative Agreement: 97.0% (131/135) 95% CI: 92.6% – 98.8%
Total Agreement: 92.4% (220/238) 95% CI: 88.4% – 95.2%  |   |   |   |

2. Matrix Comparison:

Not Applicable

C Clinical Studies:

1. Clinical Sensitivity/ Specificity:

To demonstrate the clinical performance of each NOVEOS sIgE Assay, test results of the clinical samples from atopic and healthy, non-atopic donors evaluated in the method comparison study were compared to a clinical diagnosis of allergy. The atopic donors with a clinical history of allergy-like symptoms were identified as positive by skin prick testing (SPT) and clinical history; and the non-atopic donors with no reported allergy. Results are expressed as positive when a sample with a sIgE value is greater than or equal to 0.35 kU/L or negative when a sample with a sIgE value is less than 0.35 kU/L. The clinical sensitivity and specificity in this study cohort are summarized in the following tables:

K200825 - Page 14 of 16

{14}

|   | Clinical Diagnosis  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Atopic | Non-atopic | Total  |
|  NOVEOS sIgE Assay, E001 | Positive | 53 | 0 | 53  |
|   |  Negative | 17 | 130 | 147  |
|   |  Total | 70 | 130 | 200  |
|   |  Sensitivity: 75.7% (53/70) 95% CI: 64.5% - 84.2%
Specificity: 100.0% (130/130) 95% CI: 97.1% - 100.0%  |   |   |   |
|   | Clinical Diagnosis  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Atopic | Non-atopic | Total  |
|  NOVEOS sIgE Assay, G006 | Positive | 48 | 1 | 49  |
|   |  Negative | 15 | 124 | 139  |
|   |  Total | 63 | 125 | 188  |
|   |  Sensitivity: 76.2% (48/63) 95% CI: 64.4% - 85.0%
Specificity: 99.2% (124/125) 95% CI: 95.6% - 99.9%  |   |   |   |

2. Other Clinical Supportive Data:

Not applicable

D Clinical Cut-Off:

The clinical cut-off of the assay is 0.35 kU/L. The interpretation of results of the assay uses the following classification system:

|  Class | Concentration (kU/L) | Interpretation  |
| --- | --- | --- |
|  0 | <0.35 | Negative  |
|  I | 0.35 to <0.70 | Positive with increasing sIgE concentration  |
|  II | 0.70 to <3.50  |   |
|  III | 0.35 to <17.50  |   |
|  IV | 17.50 to <50.00  |   |
|  V | 50.00 to <100.00  |   |
|  VI | ≥100  |   |

E Expected Values/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, E001 and NOVEOS sIgE, G006 in the normal population were evaluated by testing samples from 132 apparently healthy subjects in the clinical study for E001 and 127 apparently healthy subjects in the clinical study for G006. All samples were below &lt;0.35 kU/L.

K200825 - Page 15 of 16

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F Other Supportive Instrument Performance Characteristics Data:
Not Applicable

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

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

K200825 - Page 16 of 16

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHB/K200825](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHB/K200825)

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