NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenaria); Capture Reagent F256, Walnut (Juglans spp.) ; Capture Reagent I006, German Cockroach (Blatella germanica)

K252493 · Hycor Biomedical · DHB · Dec 23, 2025 · Immunology

Device Facts

• Record ID: K252493
• Device Name: NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenaria); Capture Reagent F256, Walnut (Juglans spp.) ; Capture Reagent I006, German Cockroach (Blatella germanica)
• Applicant: Hycor Biomedical
• Product Code: DHB · Immunology
• Decision Date: Dec 23, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5750
• Device Class: Class 2

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 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 automated, in vitro, quantitative, chemiluminescent immunoassay used in clinical laboratories to detect allergen-specific IgE in human serum. The device utilizes fluorescent-labeled magnetic, streptavidin-coated microparticles incubated with a biotinylated allergenic capture reagent (shrimp, clam, walnut, or German cockroach), the patient sample, and a horseradish peroxidase-conjugated monoclonal anti-human IgE antibody. If IgE is present, it forms a complex with the biotinylated allergen on the microparticles. After washing, an enzyme substrate is added to generate a chemiluminescent signal proportional to the IgE concentration. Results are calculated via a standard curve traceable to WHO reference reagent 11/234. The assay is performed on the NOVEOS Immunoassay Analyzer. Clinicians use these results alongside other clinical findings to diagnose IgE-mediated allergic disorders, potentially benefiting patients by identifying specific allergen sensitivities.

Clinical Evidence

Clinical study compared NOVEOS sIgE results to allergic status in 163-179 patients. Atopic status confirmed by oral food challenge, physician diagnosis, or skin-prick testing; non-atopic status confirmed by ImmunoCAP (<0.35 kU/L). Clinical sensitivity: Shrimp 70.3%, Clam 68.2%, Walnut 92.5%, German Cockroach 35.3%. Clinical specificity: Shrimp 100%, Clam 100%, Walnut 99.2%, German Cockroach 100%.

Technological Characteristics

Immunometric, chemiluminescent assay using fluorescent-labeled magnetic, streptavidin-coated microparticles. Energy source: NOVEOS Immunoassay Analyzer. Connectivity: Standalone analyzer. Software: Embedded firmware. Calibration: 6-level curve, traceable to WHO 11/234. Reaction temperature: 37°C.

Indications for Use

Indicated for the quantitative measurement of allergen-specific IgE in human serum to aid in the clinical diagnosis of IgE-mediated allergic disorders in patients suspected of having allergies to shrimp, clam, walnut, or German cockroach.

Regulatory Classification

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)

Submission Summary (Full Text)

{0}

FDA

U.S. FOOD &amp; DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

ASSAY ONLY

## I Background Information:

A 510(k) Number

K252493

B Applicant

Hycor Biomedical

C Proprietary and Established Names

NOVEOS Specific IgE (sIgE), Capture Reagent F024, Shrimp (Shrimp spp.)
NOVEOS Specific IgE (sIgE), Capture Reagent F207, Clam (Mercenaria mercenaria)
NOVEOS Specific IgE (sIgE), Capture Reagent F256, Walnut (Juglans spp.)
NOVEOS Specific IgE (sIgE), Capture Reagent I006, German Cockroach (Blatella germanica)

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:

Four new devices

B Measurand:

Allergen specific IgE to Shrimp - F024, Shrimp spp.
Allergen specific IgE to Clam - F207, Mercenaria mercenaria
Allergen specific IgE to Walnut - F256, Juglans spp.
Allergen specific IgE to German Cockroach - I006, Blatella germanica

C Type of Test:

Chemiluminescent, Quantitative

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

{1}

K252493 - Page 2 of 15

## 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 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
- Shrimp - F024, Shrimp spp.
- Clam - F207, Mercenaria mercenaria
- Walnut - F256, Juglans spp.
- German Cockroach - I006, Blatella germanica

- 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)

{2}

- 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)

## B Principle of Operation:

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 labeled with horseradish peroxidase (Conjugate IgE). 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 chemiluminescent signal detected by the instrument, the higher the amount of sIgE detected in the sample tested. 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.

## 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):

K252493 - Page 3 of 15

{3}

K252493 - Page 4 of 15
| Device & Predicate Device(s): | K252493
(Candidate Device) | K051218
(Predicate Device) |
| --- | --- | --- |
| Device Trade Name | NOVEOS Specific IgE (sIgE) | 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 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. |
| Assay Type | Quantitative | Same |
| 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 |
| Cut-off | 0.35 kU/L | Same |
| Reaction Temperature | 37°C | Same |
| **General Device Characteristic Differences** | | |
| Solid Phase | Magnetic microparticles | Cellulose derivative |
| Assay Principle | Chemiluminescent assay | Fluoroenzyme-immunoassay |
| Instrument(s) | NOVEOS Immunoassay Analyzer | Phadia 100
Phadia 250/1000/2500/5000 |
| Specimen Type | Serum | Serum or plasma (EDTA, Na-Heparin) |
| Specimen Volume | 4 μL | 40 μL |
| Detection Antibody | HRP conjugated mouse anti-human IgE monoclonal antibody | β-Galactosidase-anti-human IgE (mouse monoclonal antibody) |
| Calibrator levels | 6 levels:
0.07, 0.35, 0.7, 3.5, 17.5, 100 kU/L | 6 levels:
0, 0.35, 0.7, 3.5, 17.5, 100 kU/L |
| Time to First Result | 1 hour and 45 minutes | 1 hour 45 minutes to 2 hours and 30 minutes depending on model |

{4}

| Detection Limit | F024, Shrimp:
LoB: 0.06 kU/L
LoD: 0.08 kU/L
LoQ: 0.10 kU/L

F207, Clam:
LoB: 0.04 kU/L
LoD: 0.09 kU/L
LoQ: 0.10 kU/L

F256, Walnut:
LoB: 0.07 kU/L
LoD: 0.10 kU/L
LoQ: 0.10 kU/L

I006, German Cockroach:
LoB: 0.03 kU/L
LoD: 0.06 kU/L
LoQ: 0.10 kU/L | LoB: 0.001 kU/L
LoD: 0.02 kU/L
LoQ: 0.10 kU/L |
| --- | --- | --- |

VI Standards/Guidance Documents Referenced:

The following Clinical and Laboratory Standards Institute (CLSI) guidelines were used:

- 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 EP12-A2: User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline – Second Edition
- CLSI EP06, 2nd ed.: Evaluation of Linearity of Quantitative Measurement, Approved Guideline – Second Edition
- CLSI EP07, 3rd ed.: Interference Testing in Clinical Chemistry; Approved Guideline – Third Edition
- CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline – Second Edition
- CLSI EP25, 2nd ed: Evaluation of Stability of In Vitro Medical Laboratory Test Reagent Reagents– Second Edition
- CLSI EP28-A3c: Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline – Third Edition
- CLSI EP37, Supplemental Tables for Interference Testing in Clinical Chemistry – First Edition

K252493 - Page 5 of 15

{5}

VII Performance Characteristics (if/when applicable):

A Analytical Performance:

1. Precision/Reproducibility:

a. Within-laboratory imprecision

The within-laboratory precision study was conducted per the CLSI EP05-A3 for each of five NOVEOS Specific IgE assays. A panel of five human sera that include one or two negative samples were tested in duplicate 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 except for the highest sample). The standard deviation (SD) and %CV of the within-run, between-run, between-day, and total within-laboratory imprecision were calculated for each sample. The results for each NOVEOS Specific IgE assay are summarized in the following tables:

| NOVEOS Specific IgE, F024, Shrimp | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Sample | Mean (kU/L) | N | Within-Run | | Between Run | | Between Day | | Total | |
| | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| 1 | 0.19 | 80 | 0.01 | 4.0 | 0.01 | 4.1 | 0.01 | 5.8 | 0.02 | 8.1 |
| 2 | 0.29 | 80 | 0.01 | 4.8 | 0.01 | 4.6 | 0.02 | 5.5 | 0.03 | 8.6 |
| 3 | 1.52 | 80 | 0.07 | 4.3 | 0.06 | 3.7 | 0.03 | 2.0 | 0.09 | 6.0 |
| 4 | 6.61 | 80 | 0.23 | 3.4 | 0.09 | 1.4 | 0.33 | 5.0 | 0.41 | 6.2 |
| 5 | 84.11 | 92* | 5.29 | 6.3 | 4.98 | 5.9 | 3.21 | 3.8 | 7.94 | 9.4 |

* Sample 5 was tested in five replicates for 1st run and two replicates for 2nd run for four days, and in two replicates/run with two runs per day for 16 days, yielding N=92 datapoints

| NOVEOS Specific IgE, F207, Clam | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Sample | Mean (kU/L) | N | Within-Run | | Between Run | | Between Day | | Total | |
| | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| 1 | 0.18 | 80 | 0.01 | 8.0 | 0.03 | 14.3 | 0.00 | 0.0 | 0.03 | 16.3 |
| 2 | 0.30 | 80 | 0.01 | 4.8 | 0.03 | 9.8 | 0.01 | 4.1 | 0.03 | 11.6 |
| 3 | 1.65 | 80 | 0.08 | 4.6 | 0.01 | 0.6 | 0.05 | 2.8 | 0.09 | 5.5 |
| 4 | 8.24 | 80 | 0.26 | 3.2 | 0.16 | 1.9 | 0.25 | 3.0 | 0.39 | 4.8 |
| 5 | 82.32 | 95* | 5.81 | 7.1 | 5.03 | 6.1 | 1.71 | 2.1 | 7.87 | 9.6 |

* Sample 5 was tested in five replicates/1st run and two replicates/2nd run for 5 days and in two replicates/run with two runs per day for 15 days, yielding N=95 datapoints

| NOVEOS Specific IgE, F256, Walnut | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Sample | Mean (kU/L) | N | Within-Run | | Between Run | | Between Day | | Total | |
| | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| 1 | 0.29 | 80 | 0.01 | 5.1 | 0.02 | 6.7 | 0.01 | 2.8 | 0.03 | 8.9 |
| 2 | 0.32 | 80 | 0.02 | 6.2 | 0.04 | 11.7 | 0.02 | 6.9 | 0.05 | 14.9 |
| 3 | 1.20 | 80 | 0.05 | 4.1 | 0.05 | 4.1 | 0.03 | 2.1 | 0.07 | 6.1 |
| 4 | 3.62 | 80 | 0.12 | 3.4 | 0.00 | 0.0 | 0.12 | 3.3 | 0.17 | 4.8 |
| 5 | 83.90 | 95* | 5.72 | 6.8 | 7.55 | 9.0 | 0.00 | 0.0 | 9.47 | 11.3 |

* Sample 5 was tested in five replicates/1st run and two replicates/2nd run for 5 days and in two replicates/run with two runs per day for 15 days, yielding N=95 datapoints

K252493 - Page 6 of 15

{6}

K252493 - Page 7 of 15

| NOVEOS Specific IgE, I006, German Cockroach | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Sample | Mean (kU/L) | N | Within-Run | | Between Run | | Between Day | | Total | |
| | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| 1 | 0.21 | 80 | 0.02 | 10.4 | 0.00 | 0.0 | 0.02 | 9.1 | 0.03 | 13.8 |
| 2 | 0.43 | 80 | 0.02 | 5.1 | 0.02 | 4.1 | 0.03 | 7.7 | 0.04 | 10.1 |
| 3 | 1.51 | 80 | 0.05 | 3.3 | 0.08 | 5.3 | 0.06 | 4.1 | 0.11 | 7.4 |
| 4 | 21.12 | 80 | 0.84 | 4.0 | 1.29 | 6.1 | 1.12 | 5.3 | 1.90 | 9.0 |
| 5 | 62.86 | 82* | 2.18 | 3.5 | 3.42 | 5.4 | 2.06 | 3.3 | 4.55 | 7.2 |

* Sample 5 was tested in two replicates/run with two runs per day for 21 days with exclusion of two outliers for Day 11, yielding N=82 datapoints

## b. Lot-to-lot imprecision

A panel of four to five serum samples were tested with three different lots of each NOVEOS Specific IgE assay. The samples were tested in replicates of five per run, one run per day, for five days, to generate a total of 75 replicates per sample for all three lots. The results are summarized in the following tables:

| NOVEOS Specific IgE, F024, Shrimp | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Sample | Mean (kU/L) | N | Within-Run | | Between-Day | | Between-Lot | | Total | |
| | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| 1 | 0.19 | 75 | 0.01 | 5.1 | 0.01 | 6.1 | 0.01 | 6.1 | 0.01 | 6.1 |
| 2 | 0.54 | 75 | 0.02 | 3.6 | 0.03 | 4.9 | 0.03 | 5.7 | 0.03 | 5.7 |
| 3 | 1.58 | 75 | 0.05 | 3.0 | 0.06 | 3.7 | 0.06 | 3.9 | 0.06 | 3.9 |
| 4 | 81.84 | 75 | 5.32 | 6.5 | 6.52 | 8.0 | 0.00 | 0.0 | 8.42 | 10.3 |
| NOVEOS Specific IgE, F207, Clam | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Sample | Mean (kU/L) | N | Within-Run | | Between-Day | | Between-Lot | | Total | |
| | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| 1 | 0.21 | 75 | 0.02 | 9.2 | 0.02 | 8.0 | 0.00 | 0.0 | 0.03 | 12.1 |
| 2 | 0.54 | 79* | 0.02 | 4.5 | 0.04 | 7.5 | 0.00 | 0.0 | 0.05 | 8.7 |
| 3 | 1.65 | 75 | 0.06 | 3.7 | 0.02 | 1.3 | 0.01 | 0.5 | 0.07 | 4.0 |
| 4 | 8.27 | 75 | 0.34 | 4.1 | 0.09 | 1.1 | 0.03 | 0.3 | 0.35 | 4.2 |
| 5 | 85.43 | 75 | 7.01 | 8.2 | 5.99 | 7.0 | 0.00 | 0.0 | 9.22 | 10.8 |

* Sample 2 was tested in five replicates/run with one run per day for six days with exclusion of one outlier for Day 1 using Lot 1, yielding N=79 datapoints

| NOVEOS Specific IgE, F256, Walnut | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Sample | Mean (kU/L) | N | Within-Run | | Between-Day | | Between-Lot | | Total | |
| | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| 1 | 0.14 | 75 | 0.02 | 11.8 | 0.01 | 10.2 | 0.00 | 0.0 | 0.02 | 15.6 |
| 2 | 0.46 | 75 | 0.03 | 7.3 | 0.02 | 4.6 | 0.00 | 0.0 | 0.04 | 8.6 |
| 3 | 1.19 | 75 | 0.05 | 4.4 | 0.04 | 3.0 | 0.05 | 3.8 | 0.08 | 6.6 |
| 4 | 21.43 | 75 | 0.79 | 3.7 | 0.39 | 1.8 | 0.30 | 1.4 | 0.93 | 4.4 |
| 5 | 91.83 | 75 | 6.28 | 6.8 | 3.49 | 3.8 | 2.09 | 2.3 | 7.48 | 8.1 |

{7}

K252493 - Page 8 of 15

| NOVEOS Specific IgE, I006, German Cockroach | | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Sample | Mean (kU/L) | N | Within-Run | | Between-Day | | Between-Lot | | Total | |
| | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| 1 | 0.12 | 75 | 0.01 | 10.5 | 0.02 | 13.6 | 0.00 | 0.0 | 0.02 | 17.2 |
| 2 | 0.47 | 75 | 0.02 | 4.9 | 0.02 | 3.3 | 0.01 | 1.5 | 0.03 | 6.0 |
| 3 | 1.14 | 75 | 0.06 | 5.0 | 0.02 | 2.1 | 0.10 | 8.9 | 0.12 | 10.4 |
| 4 | 21.32 | 75 | 0.69 | 3.3 | 0.75 | 3.5 | 0.45 | 2.1 | 1.11 | 5.2 |
| 5 | 83.67 | 75 | 5.15 | 6.2 | 5.41 | 6.5 | 0.00 | 0.0 | 7.47 | 8.9 |

## 2. Linearity:

Linearity of each NOVEOS Specific IgE assay was evaluated in accordance with the CLSI guideline I/LA20-A3. Three sets of linearity dilution panels including six levels were prepared by using three positive human serum samples (low, mid, and high) diluted with one negative serum sample. Three dilution panels overlapped and created the full dilution panel. Testing was performed using one lot of each NOVEOS Specific IgE Assay in four replicates of each sample. The linearity data analysis was performed individually for each NOVEOS Specific IgE Assay in accordance with the CLSI EP06, 2nd Edition. For each sample level in the dilution panels, the mean value of the measured values, the predicted value and the % deviation from linearity were calculated. The results for each NOVEOS Specific IgE Assay are shown in the tables below:

| NOVEOS Specific IgE, F024, Shrimp | | | | | |
| --- | --- | --- | --- | --- | --- |
| Dilution Panel | Range (kU/L) | Slope (95% CI) | Intercept (95% CI) | R² | % Deviation from Linearity |
| 1 | 0.03–3.80 | 0.92 (0.85–0.99) | 0.02 (0.01–0.03) | 0.996 | -4.9%–9.1% |
| 2 | 1.01–55.93 | 0.89 (0.80–0.98) | 0.18 (-0.04–0.40) | 0.992 | -3.2%–11.8%* |
| 3 | 1.95–130.70 | 0.87 (0.82–0.91) | 0.05 (-0.17–0.28) | 0.998 | -9.5%–9.6% |
| All | 0.03–130.70 | 0.91 (0.88–0.94) | 0.02 (0.01–0.03) | 0.995 | -9.5%–11.8% |

* % Deviation from linearity of 11.8% for sample level with IgE concentration of 1.91 kU/L

| NOVEOS Specific IgE, F207, Clam | | | | | |
| --- | --- | --- | --- | --- | --- |
| Dilution Panel | Range (kU/L) | Slope (95% CI) | Intercept (95% CI) | R² | % Deviation from Linearity |
| 1 | 0.08–3.92 | 1.02 (0.98–1.06) | -0.01 (-0.02–0.00) | 0.999 | 2%–14%* |
| 2 | 0.34–24.70 | 0.95 (0.87–1.04) | -0.06 (-0.11– -0.01) | 0.994 | -14%**–3% |
| 3 | 1.45–95.09 | 1.08 (0.99–1.17) | -0.43 (-0.80– -0.06) | 0.995 | -10%–12%*** |
| All | 0.08–95.09 | 0.99 (0.93–1.04) | -0.02 (-0.04–0.01) | 0.987 | -14%–14% |

* % Deviation from linearity of 14% for sample level with IgE concentration of 0.08 kU/L
** % Deviation from linearity of -14% for sample levels with IgE concentrations of 0.34, 0.67, and 1.32 kU/L
*** % Deviation from linearity of 12% for sample level with IgE concentration of 52.74 kU/L

| NOVEOS Specific IgE, F256, Walnut | | | | | |
| --- | --- | --- | --- | --- | --- |
| Dilution Panel | Range (kU/L) | Slope (95% CI) | Intercept (95% CI) | R² | % Deviation from Linearity |
| 1 | 0.06–2.22 | 0.99 (0.96–1.02) | -0.00 (-0.02–0.02) | 0.999 | -4%–9% |
| 2 | 1.06–69.05 | 0.91 (0.82–1.00) | -0.17 (-0.56–0.21) | 0.992 | -14%*–4% |
| 3 | 1.46–88.83 | 1.00 (0.99–1.02) | -0.03 (-0.12–0.05) | 1.000 | 0%–7% |
| All | 0.06–88.83 | 0.97 (0.93–1.00) | 0.00 (-0.04–0.04) | 0.995 | -14%–9% |

* % Deviation from linearity of -14% for sample level with IgE concentration of 3.65 kU/L

{8}

| NOVEOS Specific IgE Assay, I006, German Cockroach | | | | | |
| --- | --- | --- | --- | --- | --- |
| Dilution Panel | Range (kU/L) | Slope (95% CI) | Intercept (95% CI) | R² | % Deviation from Linearity |
| 1 | 0.09–1.02 | 0.97 (0.91–1.03) | -0.25 (-0.51–0.02) | 0.999 | -9%-4% |
| 2 | 0.89–53.98 | 0.99 (0.96–1.02) | -0.05 (-0.13–0.04) | 0.999 | -1%-6% |
| 3 | 1.54–110.48 | 1.00 (0.97–1.03) | -0.01 (-0.01–0.00) | 0.997 | -15%*–4% |
| All | 0.09–110.48 | 0.96 (0.93–0.99) | 0.00 (-0.01–0.01) | 0.996 | -15%-6% |

* % Deviation from linearity of -15% for sample level with IgE concentration of 2.88 kU/L

The linear range and the claimed analytical meaning range for each NOVEOS Specific IgE are shown in the table below:

| NOVEOS Specific IgE | Tested Linear Range | Analytical Measuring Range |
| --- | --- | --- |
| F024, Shrimp | 0.03 – 130.70 kU/L | 0.10 – 100.0 kU/L |
| F207, Clam | 0.08 – 95.09 kU/L | 0.10 – 95.0 kU/L |
| F256, Walnut | 0.06 – 88.83 kU/L | 0.10 – 88.0 kU/L |
| I006, German Cockroach | 0.09 – 110.48 kU/L | 0.10 – 100.0 kU/L |

## 3. Analytical Specificity/Interference:

### a. Inhibition study:

Immunological specificity of each NOVEOS Specific IgE Assay was verified through competitive inhibition study according to the CLSI I/LA20-A3. Positive samples with specific IgE concentration used in the study include: 7.64 kU/L for F024, Shrimp; 13.33 kU/L for F207, Clam; 1.39 kU/L for F256, Walnut; and 1.62 kU/L for I006, German Cockroach.

The allergen solution (inhibitor) was diluted 1:1 into the positive serum sample to achieve a starting concentration of 50 µg/mL for F024 and for F207, 100 µg/mL for F256 and for I006. The sample solution was serially diluted five times in two-fold increments and each diluted sample was evaluated for dose-dependent inhibition in four replicates using one lot of NOVEOS sIgE for F207, F256, and I006, and two lots for F024. The results of the dose-dependent inhibition study showed that ≥85% inhibition was achieved at a final µg/mL inhibitor concentration of 12.5 µg/mL for F024, 50 µg/mL for F207, 100 µg/mL for F256, and 25 µg/mL for I006.

For the NOVEOS Specific IgE assays, F024, F207, F256, and I006, the related and unrelated allergens tested were as follows:

- For F024, Shrimp, the related allergen F202 (Cashew Nut) and the unrelated allergens D070 (Acarus Siro), M012 (Aureobasidium pullulans), T009 (Olive Pollen), and W006 (Mugwort) were tested as potential inhibitors at a final concentration of at least ten times the concentration of F024 at which ≥85% inhibition was achieved. All allergen inhibitors were spiked into the positive serum sample at a 1:1 dilution and evaluated with one lot of NOVEOS Specific IgE, F024. The results of the single-dose inhibition studies did not show inhibition at a test concentration of 125 µg/mL for the

K252493 - Page 9 of 15

{9}

related allergen and unrelated allergens. The inhibition studies indicate that the NOVEOS Specific IgE, F024 contains the immunologically relevant allergen.

- For F207, Clam, the related allergen F040 (Yellowfin Tuna) and the unrelated allergens M006 (Alternaria Alternata), E070 (Goose Feathers), W013 (Cocklebur Pollen), and G010 (Johnson Grass) were tested as potential inhibitors at a final concentration of at least ten times the highest concentration of F207 at which ≥85% inhibition was achieved. All allergen inhibitors were spiked into the positive serum sample at a 1:1 dilution and evaluated with one lot of NOVEOS Specific IgE, F207. The results of the single-dose inhibition studies did not show inhibition at a test concentration of 1335 μg/mL for the related allergen and at 830 μg/mL (M006), 3975 μg/mL (E070), 1080 μg/mL (W013), and 850 μg/ml (G010) for unrelated allergens. The inhibition studies indicate that the NOVEOS Specific IgE, F207 contains the immunologically relevant allergen.

- For F256, Walnut, the related allergen F020 (Almond) and the unrelated allergens D201 (Blomia tropicalis), T014 (Eastern Cottonwood Pollen), and W001 (Short Ragweed) were tested as potential inhibitors at a final concentration of at least ten times the final concentration of F256 that achieved ≥85% inhibition. All allergen inhibitors were spiked into the positive serum sample at a 1:1 dilution and evaluated with one lot of NOVEOS Specific IgE, F256. The results of the single-dose inhibition studies did not show inhibition at a test concentration of 2565 μg/mL for the related allergen and at 2850 μg/ml (D201), 1080 μg/ml (T014) and 1150 μg/ml (W001) for unrelated allergens. The inhibition studies indicate that the NOVEOS Specific IgE, F256 contains the immunologically relevant allergen.

- For I006, German Cockroach, the related allergen I070 (Fire Ant) and the unrelated allergens F018 (Brazil Nut), T010 (California Black Walnut), and W006 (Common Mugwort) were tested as potential inhibitors at a final concentration of at least ten times the concentration of I006 at which ≥85% inhibition was achieved. All allergen inhibitors were spiked into the positive serum sample at a 1:1 dilution and evaluated with one lot of NOVEOS Specific IgE, I006. The results of the single-dose inhibition studies did not show inhibition at a test concentration of 250 μg/mL for the related allergen and unrelated allergens. The inhibition studies indicate that the NOVEOS Specific IgE, I006 contains the immunologically relevant allergen.

b. Interference:

i. Endogenous Substance Interference:

The effect of the presence of elevated levels of human serum albumin, hemoglobin, triglycerides, 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. Testing was conducted with seven replicates in one assay run using one lot each of the NOVEOS sIgE assays for F024 (Shrimp), F207 (Clam), F256 (Walnut), and I006 (German Cockroach). The % Interference for each sample spiked with the potential interfering substance was calculated by comparing its result to that of the corresponding control sample spiked

K252493 - Page 10 of 15

{10}

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, and unconjugated bilirubin up to 20 mg/dL.

ii. Exogenous Substance Interference:

Refer to K200825.

c. Cross-reactivity:

The potential cross-reactivity of non-IgE (IgA, IgD, IgG, and IgM) to the NOVEOS sIgE Assays was evaluated in K200825.

4. Assay Reportable Range:

The assay reportable range is the same as the claimed analytical measuring range for each NOVEOS Specific IgE as shown in the table below:

| NOVEOS Specific IgE Assay | Assay Reportable Range/ Analytical Measuring Range |
| --- | --- |
| F024, Shrimp | 0.10 – 100.0 kU/L |
| F207, Clam | 0.10 – 95.0 kU/L |
| F256, Walnut | 0.10 – 88.0 kU/L |
| I006, German Cockroach | 0.10 – 100.0 kU/L |

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

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

b. Kit stability:

The stability study was conducted in accordance with CLSI EP25-A2.

Shelf-life stability: A real-time stability study for the NOVEOS Specific sIgE Capture Reagent Pack of F024, F207, F256, and I006 stored at 2–8°C is ongoing using three lots. The test was planned by testing two positive samples and one negative sample. An accelerated stability study was conducted with two positive samples and one negative sample using three lots of each Capture Reagent stored at 37°C. The result for each NOVEOS Specific sIgE Capture Reagent is summarized in the table below:

| | Shelf-life Stability (2–8°C) |
| --- | --- |
| Capture Reagent Pack F024* | 36 months |
| Capture Reagent Pack F207* | 36 months |
| Capture Reagent Pack F256* | 36 months |
| Capture Reagent Pack I006** | 2 months |

* Results based on accelerated stability data, while the real-time stability is on-going
** Results based on ongoing real time stability study

K252493 - Page 11 of 15

{11}

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 and K191510 (for the Fluo Beads reagent).

**On-board stability:** A study was performed on one instrument using three samples (two positive and one negative or low-level sample) on at least one lot of each NOVEOS Specific IgE Capture Reagent Pack F024, F207, F256, and I006 stored on the NOVEOS Immunoassay Analyzer. The test was planned by testing each sample in three replicates at Day 0 and scheduled timepoints of 15, 28, and 29 days. The timepoints were chosen to at minimum have a penultimate (Tn) and ultimate (Tn+1) timepoint. The result supports that the allergen specific capture reagent is stable for 15 days stored on-board. The result supports that the allergen specific capture reagent is stable for 15 days on-board.

The on-board stability for all the other assay components has been previously established per K182479.

**Open-vial stability:** Accelerated open vial stability studies were performed using one lot for F024, F207, F256, and I006 capture reagents. The studies evaluated opened capture reagent vials filled to 100% and 50% fill volume, stored at 37°C for up to 10 days to simulate the stress of real-time aging. The allergen specific capture reagent is stable for 15 days once opened and stored at 2-8°C.

## 6. Detection Limit:

The limit of blank (LoB), limit of detection (LoD), and limit of quantitation (LoQ) of each NOVEOS sIgE assay, i.e., F024 (Shrimp), F207 (Clam), F256 (Walnut), and I006 (German Cockroach), on the NOVEOS Immunoassay Analyzer were determined according to CLSI guideline EP17-A2.

**LoB:** The LoB was determined by testing four analyte-free human serum samples in replicates of five per run, over three runs, with no more than one run per day, using two lots of each capture reagent on one or two NOVEOS Immunoassay Analyzers. Only the NOVEOS Specific IgE Assay for F256 was evaluated on two NOVEOS Immunoassay Analyzers. The LoB was estimated as the 95th percentile of the 60 measurements for each of the two lots tested.

**LoD:** The LoD was determined by testing protocol summarized in the table below:

| NOVEOS sIgE | No. of Samples | No. of Lots | No. of Analyzers | Testing Protocol |
| --- | --- | --- | --- | --- |
| F024 | 4 | 2 | 1 | 4 samples x 5 replicates/run x 3 runs = 60/Lot |
| F207 | 5 | 2 | 1 | 5 samples x 5 replicates/run x 3 runs = 75/Lot |
| F256* | 5 | 2 | 2 | 5 samples x 5 replicates/run x 3 runs = 75/Lot |
| I006 | 4 | 2 | 1 | 4 samples x 5 replicates/run x 3 runs = 60/Lot |

* LoD study was evaluated on two NOVEOS Immunoassay Analyzers.

K252493 - Page 12 of 15

{12}

The LoD was calculated and determined to be the highest value across two lots tested for each NOVEOS sIgE assay.

LoQ: The LoQ was determined by testing four low IgE samples with three replicates per run over three testing days using two lots of each capture reagent on one NOVEOS Immunoassay Analyzer resulting in a total of 36 replicates across all samples per lot. 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 two lots tested and are summarized in the table below.

| NOVEOS Specific IgE | LoB (kU/L) | LoD (kU/L) | LoQ (kU/L) |
| --- | --- | --- | --- |
| F024, Shrimp | 0.06 | 0.08 | 0.10 |
| F207, Clam | 0.04 | 0.09 | 0.10 |
| F256, Walnut | 0.07 | 0.10 | 0.10 |
| I006, German Cockroach | 0.03 | 0.06 | 0.10 |

7. Assay Cut-Off:

See clinical cut-off.

B Comparison Studies:

1. Method Comparison with Predicate Device:

Refer to clinical study section below.

2. Matrix Comparison:

Not Applicable

C Clinical Studies:

1. Clinical Sensitivity and Specificity:

For each NOVEOS Specific IgE assay, the clinical performance was evaluated by comparing the test results from a cohort of atopic and non-atopic samples to the clinical diagnosis of allergy. The atopic samples were from different U.S. and EU vendors with a clinical history of allergy-like symptoms and identified as positive by skin prick testing (SPT results with certificate of analysis), oral food challenge (OFC), or diagnosed positive by a physician. The non-atopic samples were from donors with no reported allergy and were deemed negative by ImmunoCAP testing (&lt;0.35 kU/L). The sIgE test results are expressed as positive or negative using a cut-off of 0.35 kU/L. The clinical sensitivity and clinical specificity for each NOVEOS Specific IgE Assay are summarized in the following tables:

K252493 - Page 13 of 15

{13}

| | Clinical Diagnosis | | | |
| --- | --- | --- | --- | --- |
| | | Atopic | Non-atopic | Total |
| NOVEOS Specific IgE, F024, Shrimp | Positive | 26 | 0 | 26 |
| | Negative | 11 | 122 | 133 |
| | Total | 37 | 122 | 159 |
| | Sensitivity: 70.3% (26/37) (95% CI: 54.2% to 82.5%) Specificity: 100.0% (122/122) (95% CI: 96.9% to 100.0%) | | | |
| | Clinical Diagnosis | | | |
| --- | --- | --- | --- | --- |
| | | Atopic | Non-atopic | Total |
| NOVEOS Specific IgE, F207, Clam | Positive | 30 | 0 | 28 |
| | Negative | 14 | 120 | 147 |
| | Total | 44 | 120 | 175 |
| | Sensitivity: 68.2% (30/44) (95% CI: 53.4% to 80.0%) Specificity: 100.0% (120/120) (95% CI: 96.9% to 100.0%) | | | |
| | Clinical Diagnosis | | | |
| --- | --- | --- | --- | --- |
| | | Atopic | Non-atopic | Total |
| NOVEOS Specific IgE, F256, Walnut | Positive | 37 | 1 | 32 |
| | Negative | 3 | 121 | 125 |
| | Total | 40 | 122 | 157 |
| | Sensitivity: 92.5% (37/40) (95% CI: 80.1% to 97.4%) Specificity: 99.2% (121/122) (95% CI: 95.5% to 99.9%) | | | |
| | Clinical Diagnosis | | | |
| --- | --- | --- | --- | --- |
| | | Atopic | Non-atopic | Total |
| NOVEOS Specific IgE, I006, German Cockroach* | Positive | 12 | 0 | 12 |
| | Negative | 22 | 129 | 151 |
| | Total | 34 | 129 | 163 |
| | Sensitivity: 35.3% (12/34) (95% CI: 21.5% to 52.1%) Specificity: 100.0% (129/129) (95% CI: 97.1% to 100.0%) | | | |

* All atopic samples are only SPT positive

The following literature was published related to the observed low performance:

| NOVEOS sIgE | Literature Citation(s) | Prevalence | Reported Performance |
| --- | --- | --- | --- |
| F024, Shrimp Sensitivity: 70.3% Specificity: 100.0% | Ye, YM, et al. Allergy Asthma Immunol Res. 2025;17:359–370 | Not reported | Serum IgE Test (Shrimp Extract) - concordance of 67.1%. |
| F207, Clam Sensitivity: 68.2% Specificity: 100.0% | Maldonado, S. et al. Journal of Allergy and Clinical Immunology, Volume 125, Issue 2, AB203 (2010) | 0.05–0.15% | An overall agreement of 86% with clinical diagnosis (atopic and non-atopic) |
| F256, Walnut Sensitivity: 92.5% Specificity: 99.2% | • Weinberger T and Sicherer S. J Asthma Allergy. 2018;11:41–51. • Fleischer DM, et al. J Allergy Clin Immunol. 2005;116(5):1087–1093 | ~0.5% | OFC: Sensitivity: 87% to 95% Specificity:60% to 75% |

K252493 - Page 14 of 15

{14}

K252493 - Page 15 of 15

| 1006, Cockroach
Sensitivity: 35.3%
Specificity: 100.0% | • Sohn MH, Kim K-E. Allergy Asthma Immunol Res.
2012;4(5):264-269
• Alimuddin S et al. Acta Medica Indonesiana. 2018;50:125–131 | ~17–41% | SPT:
Sensitivity: 24%
Specificity: 98% |
| --- | --- | --- | --- |

2. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):

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 | 3.50 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 &lt; 0.35 kU/L (negative) for a specific allergen in an apparently healthy (non-atopic) person. Each laboratory should establish its own expected value/reference range.

The reference range of NOVEOS Specific IgE Assay for F024 (Shrimp), F207 (Clam), F256 (Walnut), and I006 (German Cockroach), in the normal population was evaluated based on the data collected in clinical studies which were used to test samples from apparently healthy subjects including: 122 non-atopic samples for F024; 120 non-atopic samples for F207; 122 non-atopic samples for F256; and 129 non-atopic samples for I006, tested by corresponding NOVEOS Specific IgE Assay. All samples tested with the NOVEOS Specific IgE Assay for F024 (Shrimp), F207 (Clam), and I006 (German Cockroach) were below &lt;0.35 kU/L. Of the 122 non-atopic samples, one tested positive (IgE =0.40 kU/L) with the NOVEOS Specific IgE Assay for F256 (Walnut).

## 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.