NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus

K182479 · Hycor Biomedical · DHB · Dec 4, 2018 · Immunology

Device Facts

• Record ID: K182479
• Device Name: NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus
• Applicant: Hycor Biomedical
• Product Code: DHB · Immunology
• Decision Date: Dec 4, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5750
• Device Class: Class 2

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. The NOVEOS™ Immunoassay Analyzer is an automated chemiluminescent immunoassay analyzer for measurement of analyte concentration in human specimens. It is intended for in vitro diagnostic use in the clinical laboratory.

Device Story

The NOVEOS system is a high-throughput, automated chemiluminescent immunoassay analyzer for clinical laboratories. It processes human serum samples to quantify allergen-specific IgE. The system uses magnetic, streptavidin-coated microparticles as a solid phase, incubated with biotinylated allergenic capture reagents, patient samples, and monoclonal anti-human IgE horseradish peroxidase conjugate. After washing, an enzyme substrate is added to generate a chemiluminescent signal proportional to the IgE concentration. The analyzer performs all processing steps, including liquid handling via robotic pipettors and signal detection. Results are calculated against a standard curve traceable to WHO reference reagent 11/234. Clinicians use these quantitative results alongside other clinical findings to diagnose IgE-mediated allergic disorders. The system benefits patients by providing standardized, automated allergy testing.

Clinical Evidence

Clinical performance evaluated in 236 subjects (117 atopic, 119 healthy). Atopic status confirmed via skin prick testing (SPT). Sensitivity 76.9% (95% CI: 68.5%–83.6%); Specificity 100.0% (95% CI: 96.9%–100.0%). Method comparison with predicate (n=234) showed 91.49% positive agreement, 98.57% negative agreement, and 95.73% total agreement at 0.35 kU/L cut-off.

Technological Characteristics

Automated chemiluminescent immunoassay analyzer. Uses magnetic, streptavidin-coated microparticles as solid phase. Reagents include biotinylated allergenic capture reagents and monoclonal anti-human IgE-HRP conjugate. Detection via chemiluminescence and fluorescence. High-throughput, robotic liquid handling. Traceable to WHO reference reagent 11/234. Software-controlled processing.

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, specifically to House Dust Mite (Dermatophagoides pteronyssinus).

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)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number:
K182479

B. Purpose for Submission:
New assay and new instrument

C. Measurand:
Allergen specific IgE

D. Type of Test:
Chemiluminescent, Quantitative

E. Applicant:
Hycor Biomedical, LLC

F. Proprietary and Established Names:
NOVEOS™ Specific IgE (sIgE) Assay, Capture Reagent House Dust Mite D001, Dermatophagoides pteronyssinus
NOVEOS™ Immunoassay Analyzer

G. Regulatory Information:

1. Regulation section:
21 CFR §866.5750 – Radioallergosorbent (RAST) immunological test system
21 CFR §862.2160 – Discrete photometric chemistry analyzer for clinical use

2. Classification:
Class II – Assay
Class I – Instrument

3. Product code:
DHB – System, test, radioallergosorbent (RAST), immunological
JJE – Analyzer, chemistry (photometric, discrete), for clinical use

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4. Panel:

Immunology (82)

Chemistry (75)

H. Intended Use:

1. Intended uses:

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.

The NOVEOS™ Immunoassay Analyzer is an automated chemiluminescent immunoassay analyzer for measurement of analyte concentration in human specimens. It is intended for in vitro diagnostic use in the clinical laboratory.

2. Indications for use:

Same as intended use

3. Special conditions for use statement:

For prescription use only

4. Special instrument requirement:

For use on the NOVEOS™ Immunoassay Analyzer

I. Device Description:

The NOVEOS™ 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
- House Dust Mite D001, Dermatophagoides pteronyssinus
- 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)

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- IgE Positive Control Pack (known to be >0.35 kU/L)
- IgE Negative Control Packs (known to be <0.35 kU/L)
- 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)
- Sample 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.

# J. Substantial Equivalence Information:

1. Predicate device name and 510(k) number:

ImmunoCAP Specific IgE Assay and ImmunoCAP Specific IgE Conjugate 100 and Conjugate 400 (K051218)

2. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device NOVEOS™ sIgE Assay | Predicate ImmunoCAP Specific IgE Assay (K051218) |
| Intended Use | The NOVEOS™ Specific IgE 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 |

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| Similarities | | |
| --- | --- | --- |
| Item | Device NOVEOSTM sIgE Assay | Predicate ImmunoCAP Specific IgE Assay (K051218) |
| Allergen | Whole extract of allergen material: House Dust Mite, Dermatophagoides pteronyssinus | 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 |
| Differences | | |
| --- | --- | --- |
| Item | Device NOVEOSTM sIgE Assay | Predicate ImmunoCAP Specific IgE Assay (K051218) |
| Specimen Type | Serum | Serum and plasma (EDTA, Na-Heparin) |
| Solid Phase | Magnetic microbeads | Cellulose derivative |
| Instrument(s) | NOVEOSTM Immunoassay Analyzer | Phadia 100, Phadia 250/1000/2500/5000 |
| Assay Principle | Chemiluminescent assay | Fluoroenzymeimmunoassay |
| 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 | LoB: 0.03 kU/L LoD: 0.07 kU/L LoQ: 0.17 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 |

# K. Standard/Guidance Document Referenced (if applicable):

- CLSI I/LA20-A3, Performance Characteristics, Quality Assurance, and Clinical Utility of Immunological Assays for Human Immunoglobulin E Antibodies and Defined Allergen

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Specificities, Approved Guideline–Third Edition

- CLSI EP05-A3, Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline–Third Edition.
- CLSI EP6-A, Evaluation of Linearity of Quantitative Measurement, Approved Guideline
- CLSI EP17-A2, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline – Second Edition
- CLSI EP25-A, Evaluation of Stability of In Vitro Diagnostic Reagents, Approved Guideline

L. Test Principle:

The NOVEOS™ 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.

M. Performance Characteristics:

1. Analytical performance: All results presented below met the manufacturer’s pre-determined acceptance criteria.

a. Precision/Reproducibility:

i) Within-laboratory imprecision:

Imprecision of the NOVEOS™ sIgE Assay, D001 was evaluated by testing a panel of eight (two negative and six positive) serum samples with concentrations that cover the assay range. Samples were tested in two replicates per run, two runs per day for 20 days using one reagent lot on two NOVEOS™ Immunoassay Analyzers for a total of 80 replicates per sample. The SD and %CV of the within-run, between-run, between-day, and total imprecision were calculated for each sample and results are summarized in the following table:

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| Sample | Mean (kU/L) | Within-Run | | Between-Run | | Between-Day | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | SD | CV (%) | SD | CV (%) | SD | CV (%) | SD | CV (%) |
| LOQ1 | 0.17 | 0.01 | 8.4 | 0.03 | 16.3 | 0.01 | 7.1 | 0.03 | 19.7 |
| PP02 | 0.32 | 0.02 | 6.6 | 0.02 | 5.1 | 0.02 | 5.1 | 0.03 | 9.8 |
| PP03 | 1.70 | 0.07 | 4.0 | 0.09 | 5.1 | 0.04 | 2.6 | 0.12 | 7.0 |
| PP04 | 9.20 | 0.48 | 5.2 | 0.11 | 1.2 | 0.34 | 3.7 | 0.60 | 6.5 |
| PP05 | 0.50 | 0.02 | 3.4 | 0.03 | 5.2 | 0.02 | 4.0 | 0.04 | 7.3 |
| PP7 | 0.47 | 0.02 | 5.3 | 0.03 | 6.1 | 0.02 | 3.3 | 0.04 | 8.7 |
| PP08 | 15.05 | 0.91 | 6.0 | 0.00 | 0.0 | 1.06 | 7.0 | 1.39 | 9.3 |
| PP10E | 79.98 | 3.51 | 4.4 | 3.68 | 4.6 | 3.50 | 4.4 | 6.17 | 7.7 |

ii) Lot-to-lot imprecision:

Three different lots of the NOVEOS™ sIgE Assay, D001 were evaluated using a panel of five (one negative and four positive) serum samples in five replicates per run, one run per day for five days (for a total of 75 replicates per sample). The results are summarized in the following table:

| Sample | Mean (kU/L) | Within-Run | | Between-Day | | Between-Lot | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | SD | CV (%) | SD | CV (%) | SD | CV (%) | SD | CV (%) |
| LOQ 3 | 0.21 | 0.01 | 4.7 | 0.01 | 4.6 | 0.01 | 3.7 | 0.02 | 7.6 |
| PP2 | 0.37 | 0.02 | 5.2 | 0.02 | 5.1 | 0.04 | 9.6 | 0.05 | 12.1 |
| PP4 | 11.02 | 0.49 | 4.5 | 0.34 | 3.1 | 1.30 | 11.8 | 1.43 | 13.0 |
| PP40 | 27.41 | 1.43 | 5.2 | 0.97 | 3.5 | 3.26 | 11.9 | 3.69 | 13.5 |
| PP12 | 80.02 | 3.98 | 5.0 | 3.85 | 4.8 | 6.69 | 8.4 | 8.69 | 10.9 |

iii) Site-to-site reproducibility:

A panel of six patient (one negative and five positive) serum samples and two controls (LYP and NOV) was assayed 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 replicates per sample). The results are summarized in the following table:

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| Sample | Mean (kU/L) | Within-Run | | Between-Day | | Between-Site | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | SD | CV (%) | SD | CV (%) | SD | CV (%) | SD | CV (%) |
| LOQ3 | 0.19 | 0.01 | 5.3 | 0.00 | 0.0 | 0.00 | 0.0 | 0.01 | 5.3 |
| PP05* | 0.50 | 0.08 | 15.9 | 0.00 | 0.0 | 0.05 | 10.0 | 0.10 | 19.9 |
| PP03^ | 1.83 | 0.14 | 7.6 | 0.04 | 2.2 | 0.09 | 4.9 | 0.17 | 9.3 |
| PP04 | 9.79 | 0.44 | 4.5 | 0.16 | 1.6 | 0.50 | 5.1 | 0.69 | 7.0 |
| PP14 | 30.29 | 1.49 | 4.9 | 0.55 | 1.8 | 1.02 | 3.4 | 1.88 | 6.2 |
| PP13 | 73.78 | 3.86 | 5.2 | 0.00 | 0.0 | 2.89 | 3.9 | 4.82 | 6.5 |
| LYP | 10.51 | 0.58 | 5.5 | 0.17 | 1.6 | 0.65 | 6.2 | 0.89 | 8.5 |
| NOV | 29.85 | 1.80 | 6.9 | 0.77 | 2.6 | 0.91 | 3.0 | 2.16 | 7.2 |
| * includes an outliner with a value of 1.20 kU/L^ includes an outliner with a value of 2.67 kU/L | | | | | | | | | |

b. Linearity/assay reportable range:

Linearity of the assay was evaluated following CLSI guideline EP6-A by preparing four dilution series. Four positive serum samples were each diluted in negative serum pool generating at least five 2-fold consecutive dilutions. Each diluted sample was tested in replicates of four in one assay run using three lots of reagents. Results of the replicates for all four samples were analyzed for linearity. Regression statistics comparing the observed results (y) to expected results (x) of all samples in the four-dilution series are presented in the table below for one representative lot.

| Dilution Range (kU/L) | Regression Equation | Slope (95% CI) | Intercept (95% CI) | R² |
| --- | --- | --- | --- | --- |
| 0.03–133.27 | y=1.01x + 0.18 | 0.99–1.04 | -0.82–1.19 | 1.00 |

The data summarized in the table above support linearity throughout the claimed measuring range from $0.17\mathrm{kU / L}$ to $100\mathrm{kU / L}$ .

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

i. Traceability:

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

ii. 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 NOVEOSTM sIgE Assay, D001. The accelerated stability data support the manufacturer's claim of 24 to 48 month unopened shelf-life stability for the individual assay components listed in the table below. The real-time stability

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study is on-going and available data supports six-month unopened shelf-life stability when stored at 2–8 °C per the manufacturer’s instruction for use:

| | | Shelf-life Stability* (2–8 °C) |
| --- | --- | --- |
| Specific IgE Capture Reagent D001 | | 24 months |
| IgE Common Kit | Diluent A | 48 months |
| | Conjugate IgE | 18 months |
| | Substrate A and B | 24 months |
| | Fluo Beads | 12 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 |
| | Sample Wash Pack | 48 months |
| | Cuvette Wash Pack | 24 months |
| | Probe Wash Pack | 24 months |
| *Results based on accelerated stability data | | |

On-board stability: A real-time stability study using three lots of NOVEOS™ sIgE Assay, D001 support the on-board stability claim of 48 hours to 28 days for the individual assay components as summarized in the table below.

| | | On-board Stability* (2–8°C) |
| --- | --- | --- |
| Specific IgE Capture Reagent D001 | | 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 |
| | Sample Wash Pack | 5 days |
| | Cuvette Wash Pack | 28 days |
| | Probe Wash Pack | Not applicable |
| *Results based on real-time stability data | | |

d. Detection limit:

The limit of blank (LoB), limit of detection (LoD), and limit of Quantitation (LoQ) of the NOVEOS™ sIgE Assay, D001 on the NOVEOS™ Immunoassay Analyzer were

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determined according to CLSI guideline EP17-A2.

LoB was determined by testing three IgE-free human serum samples in ten replicates per run, one run per day, for three days on two analyzers using two lots of NOVEOS™ sIgE Assay, D001. The LoB was estimated as the 95th percentile of 90 measurements for each of the lots tested.

LoD was determined using five serum samples with low IgE concentrations. Each sample was tested in replicates of ten per run, two runs per day, for three days on two analyzers using three lots of NOVEOS™ sIgE Assay, D001. The LoD was determined for each lot based on 900 measurements 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 15 samples with low IgE concentrations. Each sample was tested in replicates of two per run, one run per day, for 20 days with three reagent lots on two instruments 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 (<20%CV).

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

| | LoB | LoD | LoQ |
| --- | --- | --- | --- |
| NOVEOS sIgE Assay, D001 | 0.03 kU/L | 0.08 kU/L | 0.17 kU/L |

e. Analytical specificity:

i. Inhibition study:

Immunological specificity of D001 (Dermatophagoides pteronyssinus) allergen was verified through competitive inhibition according to CLSI guideline I/LA20-A3. A positive sample with specific IgE concentration of 43.2 kU/L was used in the study.

The D001 allergen solution (inhibitor) was diluted into the positive serum sample to achieve a starting concentration of 100 µg/mL. The D001 sample solution was serially diluted five times in two folds and each diluted sample was evaluated for dose-dependent inhibition in five replicates with three lots of NOVEOS™ sIgE Assay, D001. The results of the dose-dependent inhibition study showed that 83% inhibition was achieved with D001 at a final inhibitor concentration of 3.1 µg/mL. The related allergen D070 (Storage mite), and the unrelated allergen, E006 (Guinea pig epithelium), E085 (Chicken feathers), F001 (Egg white), G006 (Timothy grass) and W003 (Giant ragweed) were also tested as potential inhibitors at a final concentration of at least ten times the concentration of D001 at which >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

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NOVEOS™ sIgE Assay, D001. The results of the single-dose inhibition studies using one related allergen (D007) and five unrelated allergens (E006, E085, F001, G006 and W003) did not show inhibition (<15%) at a test concentration of 31.3 μg/mL for the related allergen and 1.2 mg/mL for the five unrelated allergens. The inhibition studies indicate that the NOVEOS™ sIgE Assay, D001 contains the immunologically relevant allergen.

ii. Interference

a) Endogenous Substance Interference:

The effect of the presence of elevated level of human albumin, hemoglobin, triglyceride, conjugated bilirubin, and rheumatoid factor in serum samples was evaluated by testing four (one negative, three positive including one near 0.35 kU/L) serum samples spiked with varying levels of each interferent and analyzed in ten replicates in one assay run with three lots of NOVEOS™ sIgE Assay, D001. The % recovery for each sample spiked with the interference substance was calculated by comparing its result to that of the corresponding reference sample spiked with an equal volume of the solvent without the interference substance. No interference was noted for samples containing human serum albumin up to 120 mg/mL, hemoglobin up to 200 mg/dL, triglyceride up to 584 mg/dL, conjugated bilirubin up to 30 mg/dL, and rheumatoid factor up to 513 IU/mL.

b) 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 up to 1200 μg/L, diphenhydramine at 19.6 μmol/L, methylprednisolone at 1000 ng/mL, omalizumab at 0.12 mg/mL and ranitidine at 6.0 μg/L.

iii. Cross-reactivity:

The potential cross-reactivity of non-IgE (IgA, IgD, IgG, and IgM) to the NOVEOS™ sIgE Assay, D001 was evaluated by mixing serum samples spiked with the immunoglobulin stock solutions containing IgA, IgG, and IgM at 77.2 mg/mL and IgD at 81.24 mg/mL with immunoglobulin stripped serum to obtain a series of six two-fold serially diluted samples containing target levels of non-IgE within or above the physiological range. The control samples were prepared by serially diluting equal volumes of distilled water into stripped serum. No cross reactivity was noted up to 20.4 mg/mL for IgA, IgG and IgM, and up to 2.4 mg/mL for IgD.

f. Assay cut-off:

See clinical cut-off

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2. Comparison studies:

a. Method comparison with predicate device:

A total of 234 serum samples spanning the measuring range were tested with the NOVEOS™ sIgE Assay, D001 (candidate) and the ImmunoCAP Specific IgE, ImmunoCAP Allergen d1, House dust mite (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 table:

| | ImmunoCAP sIgE, Allergen d1 | | | |
| --- | --- | --- | --- | --- |
| | | Positive | Negative | Total |
| NOVEOS™ sIgE Assay, D001 | Positive | 86 | 2 | 88 |
| | Negative | 8 | 138 | 146 |
| | Total | 94 | 130 | 234 |

Positive Agreement: 91.49% (86/94) (95% CI: 84.10–95.62%)
Negative Agreement: 98.57% (138/140) (95% CI: 94.94–99.61%)
Total Agreement: 95.73% (220/234) (95% CI: 92.31–97.66%)

b. Matrix comparison:

Not Applicable

3. Clinical studies:

a. Clinical Sensitivity and Specificity:

To demonstrate the clinical performance of the NOVEOS™ sIgE Assay, D001, test results of the clinical samples from 117 atopic and 119 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 the non-atopic donors with no reported allergy. The clinical sensitivity and specificity in this study cohort are summarized in the following table:

| | Clinical Diagnosis | | | |
| --- | --- | --- | --- | --- |
| | | Atopic | Non-atopic | Total |
| NOVEOS™ sIgE Assay, D001 | Positive | 90 | 0 | 90 |
| | Negative | 27 | 119 | 146 |
| | Total | 117 | 119 | 236 |

Sensitivity = 76.9% (90/117) (95% CI: 68.5%–83.6%)
Specificity = 100.0% (117/119) (95% CI: 96.9%–100.0%)

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b. Other clinical supportive data (when a. and b. are not applicable):

# 4. Clinical cut-off:

The clinical cut-off of the assay is $0.35\mathrm{kU / L}$ . 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 | |

# 5. Expected values/Reference range:

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

The expected value/reference range of NOVEOSTM sIgE, D001 in the normal population was verified by testing samples from 119 apparently healthy subjects in clinical study. All 119 samples were tested below $&lt; 0.35\mathrm{kU / L}$ .

# N. Instrument Name:

The NOVEOSTM Immunoassay Analyzer

# O. System Descriptions:

# 1. Modes of Operation:

Does the applicant's device contain the ability to transmit data to a computer, webserver, or mobile device?

Yes X or No

Does the applicant's device transmit data to a computer, webserver, or mobile device using wireless transmission?

Yes or No X

# 2. Software:

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FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types:

Yes ☐ X ☐ or No ☐

3. Specimen Identification:

A barcode scanner is part of the instrument system and is used to identify specimens.

4. Specimen Sampling and Handling:

The instrument system has automated specimen sampling and handling - the Sample Arm transfers samples from tubes in the Sample Rotor to cuvettes in the Reaction Rotor.

5. Calibration:

All assays use a calibration curve which is generated from six level calibrators. A calibration curve is run with each batch of samples.

6. Quality Control:

Controls are processed exactly the same as patient samples, but yield known expected results. The manufacturer suggests that quality control specimens be run with each calibration curve to monitor assay performance. The value assigned for the positive control are with a lot-specific 2D barcode that lists what the expected values are for each test that the control supports. Negative Controls for allergy is also coded into the 2D barcode.

P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above:

Carryover:

Evaluation of instrument carryover was conducted using one lot of reagent of NOVEOS sIgE, D001 on three NOVEOS Immunoassay Analyzers. The carryover assessment is based on 11 cycle counts split over two runs per instrument. Pooled high-level patient samples with sIgE concentration of 73 kU/L were aliquoted into 11 tubes and pooled low-level patient samples with sIgE concentration of 0.24 kU/L were aliquoted into 55 tubes. During each cycle one high sample is tested followed by five low samples. 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 kU/L. Low Samples 3-5 is denoted as "very probably unaffected" and therefore should not have elevated kU/L signal. Carryover assessment is done by measuring the change (Δ) of [mean concentration of Low Sample 1] and [mean concentration of Low Samples 3-5]. The results are summarized in the table below:

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| NOVEOS Immunoassay Analyzers | Mean Conc. of Low Sample 1 (kU/L) | Mean Conc. of Low Sample 3-5 (kU/L) | Δ Carryover (kU/L) |
| --- | --- | --- | --- |
| 1 | 0.245 | 0.243 | 0.002 |
| 2 | 0.265 | 0.259 | 0.006 |
| 3 | 0.216 | 0.219 | -0.003 |

# Q. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 801 and 809, as applicable.

# R. Conclusion:

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