(240 days)
No.
The device description focuses on a chemical immunometric assay for allergen-specific IgE measurement. There are no mentions of AI, DNN, or ML, and the description of data analysis for performance studies does not indicate the use of AI beyond standard statistical methods for calculating agreements, sensitivity, specificity, and limits of detection.
No.
The device is an in vitro quantitative assay for the measurement of allergen-specific IgE in human serum, intended for use as an in vitro diagnostic aid in the clinical diagnosis of IgE mediated allergic disorders. It provides diagnostic information but does not actively treat or mitigate a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assay "is intended for use as an in vitro diagnostic aid in the clinical diagnosis of IgE mediated allergic disorders".
No
This device is a hardware-based in vitro diagnostic (IVD) assay designed to detect allergen-specific IgE in human serum using an immunoassay analyzer. Its mechanism involves chemical reactions (chemiluminescence), magnetic microparticles, and an enzyme substrate to generate a signal, which are all physical components and processes. While it quantifies a result, the core technology is biochemical and hardware-dependent, not software-only. The mention of "NOVEOS Immunoassay Analyzer" further confirms its reliance on dedicated hardware.
Yes.
The "Intended Use / Indications for Use" section explicitly states that the device is an "in vitro quantitative assay" and "intended for use as an in vitro diagnostic aid in the clinical diagnosis". The "Device Description" also details an in vitro immunometric procedure using human serum.
N/A
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.
Product codes
DHB
Device Description
The NOVEOS Specific IgE Assay is an immunometric, chemiluminescent procedure for the quantitative determination of IgE of known specificity in human serum samples. It employs fluorescent labelled magnetic, streptavidin coated microparticles which are incubated with a biotinylated allergenic capture reagent, patient sample and monoclonal anti‐human IgE antibody: horseradish peroxidase conjugate. If present in the sample, IgE binds to the biotinylated allergen captured to the streptavidin‐coated microparticles to form a complex. After a final wash, the resulting complex is incubated with the enzyme substrate and a chemiluminescent signal is generated, the magnitude of which is proportional to the concentration of IgE in the patient sample. The concentration of allergen‐specific IgE is determined from a standard curve, which is traceable to the World Health Organization (WHO) reference reagent serum Immunoglobulin E (IgE) 11/234.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Performance: A clinical study comparing NOVEOS sIgE allergen results to the allergic status of 102 to 228 patients was performed. Samples with allergic status were confirmed by skin‐prick testing or oral food challenge (32 to 88 samples), and negative samples (53 to 146) were deemed non‐atopic by ImmunoCAP testing (result = 0.35 kU/L) or negative (= 0.35 kU/L) or negative (
§ 866.5750 Radioallergosorbent (RAST) immunological test system.
(a)
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.(b)
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.
FDA 510(k) Clearance Letter - NOVEOS Specific IgE (sIgE) Assay
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
April 23, 2025
Hycor Biomedical
Aashrey Kaul
Regulatory Affairs Manager
7272 Chapman Avenue
Garden Grove, California 92841
Re: K242531
Trade/Device Name: NOVEOS Specific IgE (sIgE) Assay
Capture Reagent G010, Johnson Grass (Sorghum halepense);
Capture Reagent T007, Oak (Quercus alba);
Capture Reagent G002, Bermuda Grass (Cynodon dactylon);
Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia);
Capture Reagent E005, Dog Dander (Canis familiaris);
Capture Reagent T003, Common Silver Birch (Betula verrucosa);
Capture Reagent F001, Egg White (Gallus gallus);
Capture Reagent F002, Cow's Milk (Bos taurus)
Regulation Number: 21 CFR 866.5750
Regulation Name: Radioallergosorbent (RAST) Immunological Test System
Regulatory Class: Class II
Product Code: DHB
Dated: March 21, 2025
Received: March 24, 2025
Dear Aashrey Kaul:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
Page 2
K242531 - Aashrey Kaul
Page 2
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
Page 3
K242531 - Aashrey Kaul
Page 3
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ying Mao -S
Ying Mao, Ph.D.
Branch Chief
Division of Immunology and Hematology Devices
OHT7: Office of In Vitro Diagnostics
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K242531
Device Name:
NOVEOS Specific IgE (sIgE) Assay
Capture Reagent G010, Johnson Grass (Sorghum halepense);
Capture Reagent T007, Oak (Quercus alba);
Capture Reagent G002, Bermuda Grass (Cynodon dactylon);
Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia);
Capture Reagent E005, Dog Dander (Canis familiaris);
Capture Reagent T003, Common Silver Birch (Betula verrucosa);
Capture Reagent F001, Egg White (Gallus gallus);
Capture Reagent F002, Cow's Milk (Bos taurus)
Indications for Use (Describe):
The NOVEOS Specific IgE Assay is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum. NOVEOS Specific IgE Assay is to be used with the NOVEOS Immunoassay Analyzer. It is intended for use as an in vitro diagnostic aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings and is to be used in clinical laboratories.
Type of Use (Select one or both, as applicable):
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
Page 5
510(k) Summary - NOVEOS Specific IgE
This 510(k) summary is prepared in accordance with the requirements of 21 CFR Part 807.92.
Date of Preparation: 21st April 2025
Manufacturer: Hycor Biomedical, LLC
7272 Chapman Avenue
Garden Grove, CA 92841
Contact Person: Aashrey Kaul
Regulatory Affairs Manager
7272 Chapman Ave
Garden Grove, CA 92841
(714) 933‐3067
akaul@hycorbiomedical.com
Device Name:
NOVEOS™ Specific IgE (sIgE) Assay
Capture Reagent G010, Johnson Grass (Sorghum halepense);
Capture Reagent T007, Oak (Quercus alba);
Capture Reagent G002, Bermuda Grass (Cynodon dactylon);
Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia);
Capture Reagent E005, Dog Dander (Canis familiaris);
Capture Reagent T003, Common Silver Birch (Betula verrucosa);
Capture Reagent F001, Egg White (Gallus gallus);
Capture Reagent F002, Cow's Milk (Bos taurus);
Classification
NOVEOS™ Specific IgE (sIgE) Assay
Product Code: DHB
Class: II
CFR § 866.5750
Substantial Equivalence to: K051218
ImmunoCAP Specific IgE Assay
ImmunoCAP Allergens g10, t7, g2, w1, e5, t3, f1, and f2.
Page 1 of 24
Page 6
Indications for Use/ Intended Use
The NOVEOS™ Specific IgE Assay is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum. NOVEOS Specific IgE Assay is to be used with the NOVEOS Immunoassay Analyzer. It is intended for use as an in vitro diagnostic aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings and is to be used in clinical laboratories.
General Description
Reagents
The IgE Common reagents includes: Diluent A, Conjugate IgE, Substrate A, Substrate B, Fluo Beads™. Other required and recommended reagents include the allergen specific Capture Reagent, IgE Calibrator Set (6 levels (kU/L) ‐ Cal 0.07 IgE, Cal 0.35 IgE, Cal 0.70 IgE, Cal 3.5 IgE, Cal 17.5 IgE, Cal 100 IgE), Calibrator Antibody IgE, Probe Wash Pack, Wash Buffer Concentrate, Cuvette Wash Pack, IgE Negative Control Pack, and IgE Positive Control Pack.
Assay Principle
The NOVEOS Specific IgE Assay is an immunometric, chemiluminescent procedure for the quantitative determination of IgE of known specificity in human serum samples. It employs fluorescent labelled magnetic, streptavidin coated microparticles which are incubated with a biotinylated allergenic capture reagent, patient sample and monoclonal anti‐human IgE antibody: horseradish peroxidase conjugate. If present in the sample, IgE binds to the biotinylated allergen captured to the streptavidin‐coated microparticles to form a complex. After a final wash, the resulting complex is incubated with the enzyme substrate and a chemiluminescent signal is generated, the magnitude of which is proportional to the concentration of IgE in the patient sample. The concentration of allergen‐specific IgE is determined from a standard curve, which is traceable to the World Health Organization (WHO) reference reagent serum Immunoglobulin E (IgE) 11/234.
Device Comparison
NOVEOS Specific IgE Assay on the NOVEOS Immunoassay Analyzer is comparable to ImmunoCAP Specific IgE on the Phadia 100 or 250 Analyzer. Both are automated immunoassay systems that process all assay steps and automatically generate results. See the table on the next page.
Page 2 of 24
Page 7
Similarities and Differences
| General Device Characteristic | NOVEOS sIgE Assay | ImmunoCAP Specific IgE |
|---|---|---|
| Intended Use | The NOVEOS Specific IgE Assay is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum. NOVEOS Specific IgE Assay is to be used with the NOVEOS Immunoassay Analyzer. It is intended for use as an in vitro diagnostic aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings and is to be used in clinical laboratories. | ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma (EDTA or Na‐Heparin). ImmunoCAP Specific IgE is to be used with instruments Phadia 100, Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings, and is to be used in clinical laboratories. |
| Specimen Type | Serum | Serum or plasma (EDTA, Na Heparin) |
| Sample Volume | 4 µL | 40 µL |
| Assay Type | Quantitative | Same |
| Detection Antibody | Horseradish peroxidase conjugated mouse anti‐human IgE monoclonal antibody | β‐Galactosidase‐anti‐human IgE (mouse monoclonal antibody) |
| Detection Limit | G010, Johnson Grass: LoB: 0.03 kU/L, LoD: 0.06 kU/L, LoQ: 0.10 kU/L | |
| T007, Oak: LoB: 0.04 kU/L, LoD: 0.05 kU/L, LoQ: 0.10 kU/L | ||
| G002, Bermuda Grass: LoB: 0.03 kU/L, LoD: 0.05 kU/L, LoQ: 0.010 kU/L | LoB: 0.001 kU/L, LoD: 0.02 kU/L, LoQ: 0.10 kU/L |
Page 3 of 24
Page 8
| General Device Characteristic | NOVEOS sIgE Assay | ImmunoCAP Specific IgE |
|---|---|---|
| Detection Limit (continued) | W001, Common Ragweed: LoB: 0.03 kU/L, LoD: 0.05 kU/L, LoQ: 0.10 kU/L | |
| E005, Dog Dander: LoB: 0.03 kU/L, LoD: 0.06 kU/L, LoQ: 0.16kU/L | ||
| T003, Common Silver Birch: LoB: 0.04 kU/L, LoD: 0.08 kU/L, LoQ: 0.10 kU/L | ||
| F001, Egg White: LoB: 0.02 kU/L, LoD: 0.04 kU/L, LoQ: 0.14 kU/L | ||
| F002, Cow's Milk: LoB: 0.03 kU/L, LoD: 0.05 kU/L, LoQ: 0.10 kU/L | ||
| Laboratory Setting | Clinical Laboratory | Same |
| Assay Principles | Fluorescence adjusted, immunometric, chemiluminescent assay | Fluoroenzyme‐immunoassay |
| Solid Phase | Magnetic microparticles | Cellulose derivative |
| Calibrator Traceability | World Health Organization (WHO) reference reagent serum Immunoglobulin E (IgE) 11/234 | Same |
| Calibration Method | Heterologous interpolation based on Total IgE calibration curve | Same |
| Stored Calibration Curve | Yes, up to 28 days | Same |
| Number of Calibrators | Six | Same |
| Calibrator Levels | 0, 0.35, 0.7, 3.5, 17.5 and 100 kU/L | Same |
Page 4 of 24
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| General Device Characteristic | NOVEOS sIgE Assay | ImmunoCAP Specific IgE |
|---|---|---|
| Assay Range | G010, Johnson Grass: 0.10 – 100 kU/L | |
| T007, Oak: 0.10 – 100 kU/L | ||
| G002, Bermuda Grass: 0.10‐ 100 kU/L | ||
| W001, Common Ragweed: 0.10 – 100 kU/L | ||
| E005, Dog Dander: 0.16 – 100 Ku/L | ||
| T003, Common Silver Birch: 0.10 – 100 kU/L | ||
| F001, Egg White: 0.14 – 100 kU/L | ||
| F002, Cow's Milk: 0.10 – 100 kU/L | Same | |
| Reaction Temperature | 37°C | Same |
| Instrument(s) | NOVEOS Immunoassay Analyzer | Phadia 100, Phadia 250/1000/2500/5000 |
| Time to First Result | 1 hour 45 minutes | 1 hour 45 minutes to 2 hour 30 minutes depending on model |
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Clinical Performance
In addition to the ImmunoCAP comparison study, a clinical study that compares NOVEOS slgE allergen results to the allergic status of 102 to 228 patients was performed to support the diagnostic performance of the NOVEOS sIgE allergens G010 (Johnson Grass), T007 (Oak), G002 (Bermuda Grass), W001 (Common Ragweed), E005 (Dog Dander), T003 (Common Silver Birch), F001 (Egg White), and F002 (Cow's Milk). A total of 32 to 88 samples with allergic status (atopic) was confirmed by skin‐prick testing or oral food challenge, and the other 53 to 146 samples were deemed negative (non‐atopic) by ImmunoCAP testing (result 60 years old in US) | Not reported |
| | Mehl, A., et al. (2012). Journal of the British Society for Allergy and Clinical Immunology, 42(8), 1266‐1272. | Not reported | "low" between sIgE vs SPT on an individual basis |
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Method Comparison to ImmunoCAP
Method comparison studies to evaluate the performance of the NOVEOS sIgE allergens to ImmunoCAP were completed using 175 to 268 patient samples. Results for NOVEOS sIgE and ImmunoCAP allergens are expressed as positive when a sample has a value greater than or equal to 0.35 kU/L, and negative when a sample has an sIgE value is less than 0.35 kU/L.
Percent positive and negative agreement for each allergen under evaluation are summarized in the following table:
| NOVEOS sIgE Allergens | ImmunoCAP sIgE | Total | |
|---|---|---|---|
| Positive | Negative | ||
| G010, Johnson Grass | |||
| Positive | 100 | 1 | 101 |
| Negative | 18 | 134 | 152 |
| Total | 118 | 135 | 253 |
| Positive Agreement: 84.7% (100/118) 95% CI: 77.2% to 90.1% | |||
| Negative Agreement: 99.3% (134/135) 95% CI: 95.9% to 99.9% | |||
| Total Agreement: 92.5% (234/253) 95% CI: 88.6% to 95.1% | |||
| T007, Oak | |||
| Positive | 124 | 6 | 130 |
| Negative | 24 | 106 | 130 |
| Total | 148 | 112 | 260 |
| Positive Agreement: 83.8% (124/148) 95% CI: 77.0% to 88.9% | |||
| Negative Agreement: 94.6% (106/112) 95% CI: 88.8% to 97.5% | |||
| Total Agreement: 88.5% (230/260) 95% CI: 84.0% to 91.8% | |||
| G002, Bermuda Grass | |||
| Positive | 93 | 5 | 98 |
| Negative | 11 | 150 | 161 |
| Total | 104 | 155 | 259 |
| Positive Agreement: 89.4% (93/104) 95% CI: 82.0% to 94.0% | |||
| Negative Agreement: 96.8% (150/155) 95% CI: 92.7% to 98.6% | |||
| Total Agreement: 93.8% (243/259) 95% CI: 90.2% to 96.2% | |||
| W001, Common Ragweed | |||
| Positive | 99 | 5 | 104 |
| Negative | 37 | 95 | 132 |
| Total | 136 | 100 | 236 |
| Positive Agreement: 72.8% (99/136) 95% CI: 64.8% to 79.6% | |||
| Negative Agreement: 95.0% (95/100) 95% CI: 88.8% to 97.8% | |||
| Total Agreement: 82.2% (194/236) 95% CI: 76.8% to 86.6% |
Page 8 of 24
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| NOVEOS sIgE Allergens | ImmunoCAP sIgE | Total | |
|---|---|---|---|
| Positive | Negative | ||
| E005, Dog Dander | |||
| Positive | 88 | 3 | 91 |
| Negative | 8 | 88 | 96 |
| Total | 96 | 91 | 187 |
| Positive Agreement: 91.7% (88/96) 95% CI 84.4% to 95.7% | |||
| Negative Agreement: 96.7% (88/91) 95% CI 90.8% to 98.9% | |||
| Total Agreement: 94.1% (176/187) 95% CI: 89.8% to 96.7% | |||
| T003, Common Silver Birch | |||
| Positive | 95 | 3 | 98 |
| Negative | 4 | 73 | 77 |
| Total | 99 | 76 | 175 |
| Positive Agreement: 96.0% (95/99) 95% CI: 90.1% to 98.4% | |||
| Negative Agreement: 96.1% (73/76) 95% CI: 89.0% to 98.6% | |||
| Total Agreement: 96.0% (168/175) 95% CI: 92% to 98% | |||
| F001, Egg White | |||
| Positive | 69 | 7 | 76 |
| Negative | 8 | 179 | 187 |
| Total | 77 | 186 | 263 |
| Positive Agreement: 89.6% (69/77) 95% CI: 80.8% to 94.6% | |||
| Negative Agreement: 96.2% (179/186) 95% CI: 92.4% to 98.2% | |||
| Total Agreement: 94.3% (248/263) 95% CI: 90.8% to 96.5% | |||
| F002, Cow's Milk | |||
| Positive | 60 | 2 | 62 |
| Negative | 33 | 173 | 206 |
| Total | 93 | 175 | 268 |
| Positive Agreement: 64.5% (60/93) 95% CI: 54.5% to 73.5% | |||
| Negative Agreement: 98.9% (173/175) 95% CI: 95.9% to 99.7% | |||
| Total Agreement: 86.9 % (233/268) 95% CI: 82.4% to 90.5% |
Precision/Reproducibility
Repeatability and within‐laboratory precision of NOVEOS sIgE allergens were determined in accordance with CLSI guideline EP05‐A3: Evaluation of Precision of Quantitative Measurement Procedures – 3rd Edition and CLSI guideline EP15‐A3: User Verification of Precision and Estimation of Bias – 3rdEdition. A panel of four to five samples (two negative and two to three positive patient samples) was assayed in duplicate for two runs per day, over at least 20 days, on one NOVEOS Immunoassay Analyzer for a total of at least 80 replicates per sample. One lot of NOVEOS sIgE allergens were used for testing of each sample. The SD and % CV of the within‐run, between‐run, between‐day, and total imprecision were calculated for each sample and results are summarized in the following table:
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| Sample | N | Mean (kU/L) | Within‐Run (Repeatability) | Between‐Run | Between‐Day | Total |
|---|---|---|---|---|---|---|
| SD | CV | SD | CV | |||
| NOVEOS G010, Johnson Grass | ||||||
| 1 | 80 | 0.20 | 0.02 | 8.9% | 0.01 | 6.9% |
| 2 | 80 | 0.36 | 0.01 | 4.0% | 0.02 | 6.0% |
| 3 | 80 | 7.76 | 0.35 | 4.6% | 0.16 | 2.0% |
| 4 | 80 | 34.56 | 1.19 | 3.5% | 1.07 | 3.1% |
| 5 | 84* | 43.17 | 2.07 | 4.8% | 0.67 | 1.6% |
*Sample 5 was done with 2 replicates/run x 2 runs/day x 22 days with exclusion of 2 outliers for Day 21 and only 1 run at Day 22
| NOVEOS T007, Oak |
| 1 | 80 | 0.20 | 0.01 | 5.8% | 0.01 | 4.7% | 0.01 | 6.3% | 0.02 | 9.8% |
| 2 | 80 | 0.25 | 0.01 | 4.5% | 0.02 | 8.2% | 0.00 | 0.0% | 0.02 | 9.4% |
| 3 | 80 | 1.72 | 0.07 | 4.2% | 0.13 | 7.8% | 0.12 | 6.9% | 0.19 | 11.2% |
| 4 | 80 | 11.80 | 0.46 | 3.9% | 0.70 | 6.0% | 0.84 | 7.1% | 1.19 | 10.1% |
| 5 | 84* | 96.20 | 4.74 | 4.9% | 4.35 | 4.5% | 4.40 | 4.6% | 7.79 | 8.1% |
*Sample 5 was done with 2 replicates/run x 2 runs/day x 22 days with exclusion of 2 outliers for Day 21 and only 1 run at Day 22
| NOVEOS G002, Bermuda Grass |
| 1 | 80 | 0.14 | 0.01 | 7.5% | 0.01 | 4.0% | 0.01 | 7.4% | 0.02 | 11.3% |
| 2 | 80 | 0.22 | 0.01 | 6.0% | 0.01 | 5.6% | 0.02 | 8.0% | 0.02 | 11.4% |
| 3 | 80 | 9.14 | 0.38 | 4.1% | 0.53 | 5.8% | 0.64 | 7.0% | 0.91 | 10.0% |
| 4 | 80 | 51.34 | 2.14 | 4.2% | 4.07 | 7.9% | 4.70 | 9.2% | 6.58 | 12.8% |
| NOVEOS W001, Common Ragweed |
| 1 | 80 | 0.17 | 0.01 | 8.1% | 0.01 | 8.2% | 0.02 | 10.7% | 0.03 | 15.7% |
| 2 | 80 | 0.29 | 0.02 | 7.4% | 0.01 | 3.8% | 0.02 | 6.5% | 0.03 | 10.6% |
| 3 | 80 | 1.28 | 0.07 | 5.5% | 0.06 | 4.4% | 0.08 | 6.7% | 0.12 | 9.7% |
| 4 | 80 | 6.28 | 0.22 | 3.5% | 0.22 | 3.5% | 0.37 | 5.9% | 0.48 | 7.7% |
| 5 | 86* | 70.33 | 4.15 | 5.9% | 2.90 | 4.1% | 1.36 | 1.9% | 5.25 | 7.5% |
*Sample 5 was done with 2 replicates/run x 2 runs/day x 22 days with only 1 run at Day 22
| NOVEOS E005, Dog Dander |
| 1 | 80 | 0.16 | 0.01 | 6.7% | 0.00 | 3.0% | 0.01 | 5.5% | 0.01 | 9.2% |
| 2 | 80 | 0.34 | 0.01 | 3.9% | 0.02 | 6.0% | 0.01 | 4.2% | 0.03 | 8.3% |
| 3 | 80 | 0.86 | 0.04 | 4.4% | 0.05 | 5.8% | 0.03 | 3.8% | 0.07 | 8.2% |
| 4 | 80 | 9.14 | 0.40 | 4.4% | 0.69 | 7.5% | 0.31 | 3.4% | 0.85 | 9.3% |
| 5 | 86* | 81.48 | 4.68 | 5.7% | 2.62 | 3.2% | 2.60 | 3.2% | 5.96 | 7.3% |
*Sample 5 was done with 2 replicates/run x 2 runs/day x 22 days with only 1 run at Day 22
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| Sample | N | Mean (kU/L) | Within‐Run (Repeatability) | Between‐Run | Between‐Day | Total |
|---|---|---|---|---|---|---|
| SD | CV | SD | CV | |||
| NOVEOS T003, Common Silver Birch | ||||||
| 1 | 80 | 0.21 | 0.02 | 10.6% | 0.00 | 0.0% |
| 2 | 80 | 0.29 | 0.01 | 4.2% | 0.01 | 5.0% |
| 3 | 80 | 1.31 | 0.10 | 7.7% | 0.02 | 1.5% |
| 4 | 80 | 10.37 | 0.38 | 3.7% | 0.61 | 5.9% |
| 5 | 86* | 92.31 | 7.05 | 7.6% | 5.01 | 5.4% |
*Sample 5 was done with 2 replicates/run x 2 runs/day x 22 days with only 1 run at Day 22
| NOVEOS F001, Egg White |
| 1 | 80 | 0.14 | 0.01 | 4.2% | 0.01 | 4.8% | 0.00 | 0.0% | 0.01 | 6.4% |
| 2 | 80 | 0.31 | 0.01 | 2.9% | 0.01 | 3.1% | 0.00 | 1.5% | 0.01 | 4.5% |
| 3 | 80 | 1.21 | 0.03 | 2.4% | 0.04 | 3.6% | 0.02 | 1.8% | 0.06 | 4.7% |
| 4 | 80 | 1.49 | 0.05 | 3.4% | 0.04 | 2.4% | 0.03 | 2.0% | 0.07 | 4.7% |
| 5 | 83* | 78.75 | 4.30 | 5.5% | 1.95 | 2.5% | 3.33 | 4.2% | 5.77 | 7.3% |
*Sample 5 was done with 2 replicates/run x 2 runs/day x 22 days with exclusion of 1dropped test on Day 20 and only 1 run at Day 22
| NOVEOS F002 (Cow's Milk) |
| 1 | 80 | 0.18 | 0.02 | 9.7% | 0.00 | 2.6% | 0.01 | 3.4% | 0.02 | 10.6% |
| 2 | 80 | 0.33 | 0.01 | 3.4% | 0.01 | 3.1% | 0.01 | 4.1% | 0.02 | 6.2% |
| 3 | 80 | 3.91 | 0.11 | 2.9% | 0.14 | 3.6% | 0.10 | 2.6% | 0.21 | 5.3% |
| 4 | 80 | 22.51 | 0.72 | 3.2% | 0.73 | 3.2% | 0.23 | 1.0% | 1.05 | 4.7% |
| 5 | 86* | 59.43 | 3.34 | 5.6% | 2.02 | 3.4% | 4.93 | 8.3% | 6.29 | 10.6% |
*Sample 5 was done with 2 replicates/run x 2 runs/day x 22 days with 1 run at Day 22
Lot‐to‐lot imprecision
Lot‐to‐lot imprecision was evaluated using a panel of four serum samples tested with two to three different lots of each NOVEOS sIgE allergen. For NOVEOS sIgE allergens G002 (Bermuda Grass), F001 (Egg White), and F002 (Cow's Milk), the samples were tested in duplicate for two runs per day, over 20 days, for a total of 240 replicates per sample. For NOVEOS sIgE allergens T007 (Oak), W001 (Common Ragweed), E005 (Dog Dander), and T003 (Common Silver Birch), the samples were tested in replicates of five for one run per day, over at least 5 days, for a total of at least 50 replicates per sample. For NOVEOS sIgE allergen G010 (Johnson Grass), the samples were tested in duplicate for two runs per day, over 5 days, for a total of 60 replicates per sample. The results are summarized in the following table:
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| Sample | N | Mean (kU/L) | Within‐Run (Repeatability) | Between‐Day | Between‐Lot | Total |
|---|---|---|---|---|---|---|
| SD | CV | SD | CV | |||
| NOVEOS G010, Johnson Grass | ||||||
| 1 | 60 | 0.18 | 0.02 | 11.6% | 0.03 | 14.9% |
| 2 | 60 | 0.37 | 0.02 | 6.6% | 0.01 | 1.7% |
| 3 | 60 | 8.15 | 0.46 | 5.7% | 0.14 | 1.7% |
| 4 | 60 | 38.12 | 1.86 | 4.9% | 0.57 | 1.5% |
| NOVEOS T007, Oak |
| 1 | 75 | 0.20 | 0.02 | 8.2% | 0.03 | 14.5% | 0.00 | 0.0% | 0.03 | 16.7% |
| 2 | 75 | 0.44 | 0.02 | 5.6% | 0.04 | 8.2% | 0.00 | 0.0% | 0.04 | 9.9% |
| 3 | 75 | 1.46 | 0.06 | 4.4% | 0.14 | 9.5% | 0.08 | 5.2% | 0.17 | 11.7% |
| 4 | 75 | 10.07 | 0.37 | 3.7% | 0.51 | 5.1% | 0.38 | 3.7% | 0.73 | 7.3% |
| NOVEOS G002, Bermuda Grass |
| 1 | 240 | 0.14 | 0.02 | 13.9% | 0.01 | 6.9% | 0.01 | 6.9% | 0.02 | 17.1% |
| 2 | 240 | 0.23 | 0.03 | 11.8% | 0.02 | 9.0% | 0.02 | 7.4% | 0.04 | 16.8% |
| 3 | 240 | 9.14 | 0.38 | 4.2% | 0.64 | 7.0% | 0.00 | 0.0% | 0.88 | 9.6% |
| 4 | 240 | 51.00 | 2.46 | 4.8% | 4.67 | 9.1% | 0.00 | 0.0% | 6.43 | 12.6% |
| NOVEOS W001, Common Ragweed |
| 1 | 75 | 0.18 | 0.01 | 8.0% | 0.01 | 5.7% | 0.01 | 7.9% | 0.02 | 12.6% |
| 2 | 75 | 0.48 | 0.03 | 5.7% | 0.02 | 4.5% | 0.02 | 4.0% | 0.04 | 8.3% |
| 3 | 75 | 1.27 | 0.05 | 4.3% | 0.06 | 4.8% | 0.00 | 0.0% | 0.08 | 6.5% |
| 4 | 75 | 6.16 | 0.29 | 4.7% | 0.02 | 3.7% | 0.00 | 0.0% | 0.37 | 6.0% |
| NOVEOS E005, Dog Dander |
| 1 | 75 | 0.14 | 0.01 | 8.2% | 0.01 | 9.0% | 0.01 | 4.2% | 0.02 | 12.9% |
| 2 | 75 | 0.43 | 0.02 | 5.4% | 0.02 | 4.2% | 0.03 | 5.9% | 0.04 | 9.0% |
| 3 | 75 | 0.79 | 0.04 | 5.1% | 0.04 | 4.7% | 0.03 | 3.6% | 0.06 | 7.8% |
| 4 | 75 | 8.25 | 0.30 | 3.6% | 0.45 | 5.5% | 0.00 | 0.0% | 0.54 | 6.6% |
| NOVEOS T003, Common Silver Birch |
| 1 | 50 | 0.11 | 0.01 | 8.6% | 0.01 | 10.6% | 0.00 | 0.0% | 0.01 | 13.6% |
| 2 | 50 | 0.55 | 0.02 | 3.6% | 0.05 | 9.2% | 0.00 | 0.0% | 0.05 | 9.9% |
| 3 | 50 | 1.54 | 0.06 | 3.7% | 0.05 | 3.2% | 0.00 | 0.0% | 0.08 | 4.9% |
| 4 | 50 | 8.89 | 0.38 | 4.3% | 0.1 | 1.1% | 0.00 | 0.0% | 0.39 | 4.4% |
| NOVEOS F001, Egg White |
| 1 | 240 | 0.15 | 0.02 | 15.0% | 0.00 | 0.0% | 0.01 | 4.5% | 0.02 | 16.0% |
| 2 | 240 | 0.31 | 0.01 | 3.1% | 0.00 | 0.9% | 0.00 | 0.0% | 0.02 | 5.1% |
| 3 | 240 | 1.20 | 0.03 | 2.8% | 0.02 | 1.5% | 0.01 | 1.2% | 0.06 | 4.8% |
| 4 | 240 | 1.47 | 0.05 | 3.3% | 0.02 | 1.1% | 0.01 | 0.7% | 0.08 | 5.2% |
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| Sample | N | Mean (kU/L) | Within‐Run (Repeatability) | Between‐Day | Between‐Lot | Total |
|---|---|---|---|---|---|---|
| SD | CV | SD | CV | |||
| NOVEOS F002, Cow's Milk | ||||||
| 1 | 240 | 0.18 | 0.01 | 6.4% | 0.00 | 1.6% |
| 2 | 240 | 0.35 | 0.01 | 3.1% | 0.01 | 2.7% |
| 3 | 240 | 4.05 | 0.10 | 2.4% | 0.16 | 4.0% |
| 4 | 240 | 22.35 | 0.62 | 2.8% | 0.76 | 3.4% |
Linearity
Linearity of NOVEOS sIgE allergens was evaluated in accordance with CLSI guideline I/LA20‐3rd Edition, Analytical Performance Characteristics, Quality Assurance, and Clinical Utility of Immunological Assays for Human Immunoglobulin E Antibodies of Defined Allergen Specificities. Three sets of linearity dilution panels consisting of three neat positive human serum samples (low, mid, and high) were used for testing. One negative sample below the assay detection limit was used as the diluent. Each sample was serially diluted in a two‐fold scheme (1/2, 1/4, 1/8, 1/16, and 1/32) to create the full dilution panel. Testing was performed using one lot of each NOVEOS sIgE allergen. The linear regression statistics calculated using the weighted least squares with intercept analysis per CLSI guideline EP06‐2nd Edition, Evaluation of Linearity of Quantitative Measurement Procedures, are shown in the following tables:
NOVEOS Specific IgE Assay, G010, Johnson Grass
| Dilution Series | Dilution Range (kU/L) | Slope (95% CI) | Intercept (95% CI) | R² |
|---|---|---|---|---|
| 1 | 0.10 – 3.26 | 0.99 (0.92 to 1.07) | ‐0.00 (‐0.03 to 0.02) | 0.997 |
| 2 | 1.94 ‐ 56.15 | 0.91 (0.85 to 0.97) | 0.23 (‐0.00 to 0.46) | 0.998 |
| 3 | 3.16 ‐ 111.01 | 0.90 (0.81 to 0.97) | ‐0.10 (‐0.67 to 0.97) | 0.997 |
| All | 0.10 ‐ 111.01 | 0.95 (0.92 to 0.97) | 0.01 (‐0.01 to 0.02) | 0.997 |
NOVEOS Specific IgE Assay, T007, Oak
| Dilution Series | Dilution Range (kU/L) | Slope (95% CI) | Intercept (95% CI) | R² |
|---|---|---|---|---|
| 1 | 0.05 ‐ 1.99 | 1.00 (0.86 to 1.13) | ‐0.01 (‐0.02 to ‐0.00) | 0.987 |
| 2 | 0.63 ‐ 42.05 | 0.95 (0.91 to 0.99) | ‐0.07 (‐0.13 to 0.00) | 0.999 |
| 3 | 1.41 ‐ 113.95 | 0.86 (0.80 to 0.91) | ‐0.19 (‐0.48 to 0.10) | 0.997 |
| All | 0.05 ‐ 113.95 | 0.90 (0.86 to 0.94) | ‐0.01 (‐0.01 to ‐0.00) | 0.991 |
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NOVEOS Specific IgE Assay, G002, Bermuda Grass
| Dilution Series | Dilution Range (kU/L) | Slope (95% CI) | Intercept (95% CI) | R² |
|---|---|---|---|---|
| 1 | 0.06 ‐ 2.94 | 0.96 (0.89 to 1.03) | ‐0.03 (‐0.04 to ‐0.01) | 0.996 |
| 2 | 1.50 ‐ 51.58 | 0.96 (0.90 to 1.01) | ‐0.25 (‐0.53 to 0.03) | 0.998 |
| 3 | 2.90 ‐ 111.89 | 1.00 (0.92 to 1.07) | ‐0.70 (‐1.28 to ‐0.12) | 0.997 |
| All | 0.06 ‐ 111.89 | 0.93 (0.91 to 0.96) | ‐0.02 (‐0.04 to ‐0.01) | 0.997 |
NOVEOS Specific IgE Assay, W001, Common Ragweed
| Dilution Series | Dilution Range (kU/L) | Slope (95% CI) | Intercept (95% CI) | R² |
|---|---|---|---|---|
| 1 | 0.09 ‐ 1.60 | 0.96 (0.92 to 1.00) | ‐0.01 (‐0.02 to 0.01) | 0.999 |
| 2 | 0.74 ‐ 49.27 | 0.96 (0.94 to 0.99) | ‐0.01 (‐0.02 to 0.01) | 0.998 |
| 3 | 1.44 ‐ 94.04 | 0.91 (0.85 to 0.97) | 0.06 (‐0.10 to 0.22) | 0.997 |
| All | 0.09 ‐ 94.04 | 0.95 (0.93 to 0.97) | 0.00 (‐0.02 to 0.01) | 0.998 |
NOVEOS Specific IgE Assay, E005, Dog Dander
| Dilution Series | Dilution Range (kU/L) | Slope (95% CI) | Intercept (95% CI) | R² |
|---|---|---|---|---|
| 1 | 0.16 ‐ 3.31 | 1.12 (1.00 to 1.24) | ‐0.00 (‐0.03 to 0.06) | 0.994 |
| 2 | 0.37 ‐ 19.3 | 1.06 (0.97 to 1.14) | 0.03 (‐0.03 to 0.09) | 0.995 |
| 3 | 1.47 ‐ 102.41 | 0.99 (0.97 to 1.01) | ‐0.15 (‐0.22 to ‐0.08) | 1.000 |
| All | 0.16 ‐ 102.41 | 1.06 (1.01 to 1.11) | 0.03 (0.01 to 0.05) | 0.990 |
NOVEOS Specific IgE Assay, T003, Common Silver Birch
| Dilution Series | Dilution Range (kU/L) | Slope (95% CI) | Intercept (95% CI) | R² |
|---|---|---|---|---|
| 1 | 0.08 ‐ 3.28 | 1.00 (0.96 to 1.04) | ‐0.01 (‐0.02 to ‐0.00) | 0.999 |
| 2 | 0.67 ‐ 42.74 | 0.94 (0.87 to 1.02) | ‐0.06 (‐0.26 to 0.13) | 0.995 |
| 3 | 1.30 ‐ 92.17 | 0.99 (0.89 to 1.10) | ‐0.38 (‐0.80 to 0.03) | 0.992 |
| All | 0.08 ‐ 92.17 | 0.93 (0.90 to 0.96) | 0.00 (‐0.02 to 0.02) | 0.995 |
NOVEOS Specific IgE Assay, F001, Egg White
| Dilution Series | Dilution Range (kU/L) | Slope (95% CI) | Intercept (95% CI) | R² |
|---|---|---|---|---|
| 1 | 0.14 ‐ 3.73 | 1.05 (0.97 to 1.05) | ‐0.02 (‐0.07 to 0.08) | 0.999 |
| 2 | 0.92 ‐ 33.82 | 1.01 (0.99 to 1.02) | ‐0.18 (‐0.41 to 0.04) | 1.000 |
| 3 | 3.40 ‐ 105.97 | 1.01 (0.88 to 1.13) | 2.47 (‐3.79 to 8.73) | 0.992 |
| All | 0.14 ‐ 105.97 | 1.01 (0.98 to 1.05) | ‐0.01 (‐0.02 to 0.01) | 0.995 |
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NOVEOS Specific IgE Assay, F002, Cow's Milk
| Dilution Series | Dilution Range (kU/L) | Slope (95% CI) | Intercept (95% CI) | R² |
|---|---|---|---|---|
| 1 | 0.05 ‐ 1.78 | 0.94 (0.85 to 1.02) | ‐0.01 (‐0.02 to 0.00) | 0.993 |
| 2 | 0.78 ‐ 45.83 | 1.08 (1.01 to 1.14) | ‐0.01 (‐0.32 to 0.12) | 0.997 |
| 3 | 1.37 ‐ 96.86 | 0.98 (0.95 to 1.01) | ‐0.26 (‐0.42 to ‐0.11) | 0.999 |
| All | 0.05 ‐ 96.86 | 0.98 (0.94 to 1.01) | ‐0.01 (‐0.02 to ‐0.00) | 0.995 |
Endogenous Substance Interference
Interference testing by endogenous substances of NOVEOS sIgE allergens was carried out in accordance with CLSI guideline EP07, Interference Testing in Clinical Chemistry – Third Edition. The effect of the presence of elevated levels of human serum albumin, hemoglobin, triglyceride, conjugated bilirubin, and unconjugated bilirubin in serum samples was evaluated by testing three serum sample pools (one negative, one near the cut‐off, and one positive) spiked with varying levels of each interferent. To mimic the dilution effect caused by the spiked interferent, the same amount of respective solvent was spiked into each of the sample pools and tested as control samples.
For NOVEOS sIgE allergens G010 (Johnson Grass), G002 (Bermuda Grass), F001 (Egg White), and F002 (Cow's Milk), the samples were tested in replicates of 12 in one assay run with three different allergen lots. For NOVEOS sIgE allergens T007 (Oak), W001 (Common Ragweed), E005 (Dog Dander), and T003 (Common Silver Birch), the samples were tested in replicates of seven in one assay run with one lot of Capture Reagent.
The % recovery for each sample spiked with the potential interfering substance was calculated by comparing its result to that of the corresponding control sample. The substances listed in the table below show no significant interference at the indicated test concentrations for all allergens under evaluation.
| Substance | Concentration |
|---|---|
| Hemoglobin | 200 mg/dL |
| Conjugated Bilirubin | 30 mg/dL |
| Unconjugated Bilirubin | 20 mg/dL |
| Intralipid | 3002 mg/dL |
| Human Serum Albumin | 120 g/L |
Interference testing with rheumatoid factor (RF) was previously performed for NOVEOS sIgE allergens and found no significant interference at 513 IU/mL. For RF interference testing, refer to cleared 510(k) submissions K200825.
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Exogenous Substance Interference
Interference testing with potentially interfering exogenous substances biotin, diphenhydramine, methylprednisolone, ranitidine, and omalizumab was previously performed for NOVEOS sIgE allergens and found no significant interference at the concentrations listed in the table below. Refer to previously cleared 510(k) submission K200825.
| Substance | Concentration |
|---|---|
| Biotin | 3500 ng/mL |
| Diphenhydramine | 19.5 µmol/L |
| Methylprednisolone | 1000 ng/mL |
| Ranitidine | 19.1 µmol/L |
| Omalizumab | 0.12 mg/mL |
Cross‐Reactivity
Cross‐reactivity testing with other human immunoglobulins (IgA, IgD, IgG, and IgM) was previously performed for NOVEOS sIgE allergens that utilize the same universal anti‐IgE conjugate reagent as those currently under evaluation and found no significant interference at physiological concentrations of IgA, IgG, IgM (14.86 mg/mL), and IgG (0.173 mg/mL). Refer to previously cleared 510(k) submission K200825.
Competitive Inhibition (Analytical Specificity)
Immunological specificity of NOVEOS sIgE allergens was demonstrated through competitive inhibition in accordance with CLSI I/LA20‐3rd Edition, Analytical Performance Characteristics, Quality Assurance, and Clinical Utility of Immunological Assays for Human Immunoglobulin E Antibodies of Defined Allergen Specificities.
For each NOVEOS sIgE allergen, a positive sample was tested with specific IgE concentrations shown in the table below:
| NOVEOS sIgE Allergen | Concentration (kU/L) |
|---|---|
| G010, Johnson Grass | 1.52 |
| T007, Oak | 12.12 |
| G002, Bermuda Grass | 2.79 |
| W001, Common Ragweed | 4.88 |
| E005, Dog Dander | 3.65 |
| T003, Common Silver Birch | 2.27 |
| F001, Egg White | 2.04 |
| F002, Cow's Milk | 8.51 |
The allergen solution (inhibitor) was diluted 1:1 into the positive sample and subsequently
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serially diluted five times in two‐fold increments. Each diluted sample was evaluated for dose‐dependent inhibition in replicates of four using three lots of NOVEOS sIgE allergens G010 (Johnson Grass), G002 (Bermuda Grass), F001 (Egg White), and F002 (Cow's Milk), and one lot of NOVEOS sIgE allergens T007 (Oak), W001 (Common Ragweed), E005 (Dog Dander), and T003 (Common Silver Birch).
Related and unrelated allergen inhibitors were tested for each NOVEOS sIgE allergen in a single‐dose competitive inhibition study. The related and unrelated allergen inhibitors were tested at a concentration at least 10 times the final concentration that achieved >50% inhibition for the allergen under evaluation. The related and unrelated allergens used for each NOVEOS sIgE allergen are shown in the table below:
| NOVEOS sIgE Allergen | Related Inhibitor | Unrelated Inhibitors |
|---|---|---|
| G010, Johnson Grass | G006, Timothy Grass | • E085, Chicken Feathers |
| • F203, Pistachio Nut | ||
| • T008, Elm | ||
| T007, Oak | T006, Mountain Cedar | • E003, Horse Epithelia |
| • F004, Whole Wheat | ||
| • M003, Aspergillus fumigatus | ||
| G002, Bermuda Grass | G202, Maize, Corn | • F203, Pistachio Nut |
| • T008, Elm | ||
| • W001, Short Ragweed | ||
| W001, Common Ragweed | W014, Rough Redroot Pigweed | • E003, Horse Epithelia |
| • F004, Whole Wheat | ||
| • T003, White Birch | ||
| E005, Dog Dander | E003, Horse Epithelia | • M003, Aspergillus fumigatus |
| • T006, Mountain Cedar | ||
| • W006, Mugwort | ||
| T003, Common Silver Birch | T083, Mango Blossom | • E003, Horse Epithelia |
| • F202, Cashew Nut | ||
| • W006, Common Mugwort | ||
| • W012, Goldenrod | ||
| • W017, Firebush | ||
| F001, Egg White | F002, Cow's Milk | • G010, Johnson Grass |
| • M006, Alternaria alternata | ||
| • W006, Common Mugwort |
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| NOVEOS sIgE Allergen | Related Inhibitor | Unrelated Inhibitors |
|---|---|---|
| F002, Cow's Milk | F001, Egg White | • E085, Chicken Feathers |
| • G002, Bermuda Grass | ||
| • T008, Elm |
Inhibitor concentrations used for testing of the NOVEOS sIgE allergens are shown in the table below:
| NOVEOS sIgE Allergen | Dose‐Dependent Inhibition | Single‐Dose Inhibition |
|---|---|---|
| Highest Tested Inhibitor Conc. (µg/mL) | Final Conc. at >50% Inhibition (µg/mL) | |
| G010, Johnson Grass | 148.0 | 18.5 |
| T007, Oak | 100 | 3.125 |
| G002, Bermuda Grass | 285.5 | 17.8 |
| W001, Common Ragweed | 3.125 | 0.78 |
| E005, Dog Dander | 25 | 0.78 |
| T003, Common Silver Birch | 100 | 6.25 |
| F001, Egg White | 100 | 3.125 |
| F002, Cow's Milk | 100 | 6.25 |
Greater than 50% inhibition was achieved in the dose‐dependent inhibition studies and no inhibition was observed for the related and unrelated inhibitors for all NOVEOS sIgE allergens. The inhibition studies indicate that the NOVEOS sIgE allergens contain their respective immunologically relevant allergens.
Detection Limit
Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantitation (LoQ) of NOVEOS sIgE allergens were estimated in accordance with CLSI guideline EP17‐A2, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline – Second Edition.
Limit of Blank
For G010, Johnson Grass; G002, Bermuda Grass; F001, Egg White; F002, Cow's Milk, the study was done by using three lots of capture reagent on three NOVEOS Immunoassay Analyzers. Five analyte‐free human serum samples were tested in replicates of two per run, over six runs, with no more than one run per instrument per day, for a total of 60 replicates per lot.
For T007, Oak; W001, Common Ragweed; E005, Dog Dander; T003, Common Silver Birch, the study was done using two lots of capture reagent and one NOVEOS Immunoassay Analyzer. Four analyte‐free human serum samples were tested in replicates of five per run, over three runs, with no more than one run per day, for a total of 60 replicates per lot.
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The value at the 95th percentile of the 60 measurements for each of the lots tested was estimated.
Limit of Detection
LoD for each assay was determined by testing multiple human serum samples with low IgE concentrations using 2‐3 lots of capture reagents and on NOVEOS Immunoassay Analyzers. The study protocol is summarized in the table below:
| NOVEOS sIgE Assay | No. of Sample | No. of Lot | No. of Analyzer | Testing Protocol |
|---|---|---|---|---|
| E005 | 5 | 2 | 1 | 5 samples x 5 replicates/run x 3 runs = 75/Lot |
| F001 | 4 | 3 | 2 | 4 samples x 10 replicates/run x 6 runs = 240/Lot |
| F002 | 4 | 3 | 2 | 4 samples x 10 replicates/run x 6 runs = 240/Lot |
| G002 | 5 | 3 | 3 | 5 samples x 10 replicates/run x 6 runs = 300/Lot |
| G010 | 5 | 3 | 3 | 5 samples x 10 replicates/run x 6 runs = 300/Lot |
| T003 | 5 | 2 | 2 | 5 samples x 5 replicates/run x 3 runs = 75/Lot |
| T007 | 4 | 2 | 2 | 4 samples x 5 replicates/run x 3 runs = 60/Lot |
| W010 | 4 | 2 | 1 | 4 samples x 5 replicates/run x 3 runs = 60/Lot |
The LoD was calculated for each lot using a non‐parametric analysis.
Limit of Quantitation
LoQ was evaluated as a functional sensitivity‐based approach with no bias component to LoQ. Functional sensitivity for NOVEOS sIgE allergens G010 (Johnson Grass), T007 (Oak), G002 (Bermuda Grass), W001 (Common Ragweed), E005 (Dog Dander), T003 (Common Silver Birch), F001 (Egg White), and F002 (Cow's Milk), was determined using a set of at least four samples with low IgE concentrations and two lots of NOVEOS sIgE allergen. The samples were tested with replicates of three, over at least three testing days resulting in a total of at least 36 replicates. Data analysis was performed according to the precision profile method using within‐lab precision results. The LoQ is defined as the mean value of the lowest sample which fulfills the specification for the total within‐laboratory imprecision (