IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)

K260331 · Siemens Healthcare Diagnostics Products, Ltd. · DHB · Sep 4, 2026 · Immunology

Device Facts

Record IDK260331
Device NameIMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)
ApplicantSiemens Healthcare Diagnostics Products, Ltd.
Product CodeDHB · Immunology
Decision DateSep 4, 2026
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 866.5750
Device ClassClass 2

Indications for Use

The IMMULITE 2000 3gAllergy Specific IgE Vantage assay is for in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers — for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE-mediated allergic disorders. The test results are to be used in conjunction with clinical findings and other laboratory tests.

Device Story

The IMMULITE 2000 3gAllergy Specific IgE Vantage is a 2-step chemiluminescent immunoassay performed on IMMULITE 2000 Systems analyzers. It measures allergen-specific IgE in human serum. The assay uses a solid-phase polystyrene bead coated with anti-ligand. In the first cycle, patient serum, ligand-labeled specific allergen (e.g., Peanut F13), and a recombinant sheep monoclonal high-biotin affinity accessory reagent are incubated with the bead. Specific IgE binds to the allergen, which binds to the bead. After washing, an alkaline phosphatase-conjugated monoclonal murine anti-human IgE antibody is added. A chemiluminescent substrate is then added, producing a signal proportional to the bound IgE. The device is used in clinical laboratories by trained personnel. Results assist clinicians in diagnosing IgE-mediated allergic disorders. The inclusion of a high-biotin affinity reagent mitigates biotin interference, a key difference from the predicate. The system provides quantitative results in kU/L, aiding in the assessment of allergic sensitization.

Clinical Evidence

Clinical performance was evaluated using 217 samples. Sensitivity was 83% (110/132; 95% CI: 76–89%) in subjects with clinically diagnosed peanut allergy. Specificity was 94% (80/85; 95% CI: 87–97%) in atopic subjects without peanut allergy. Method comparison against the predicate (n=162) showed a regression equation of y = 0.95x - 0.089 kU/L (r=0.99). Analytical studies confirmed linearity (0.100–100 kU/L), LoQ (0.100 kU/L), and biotin interference tolerance up to 600 ng/mL.

Technological Characteristics

Solid-phase chemiluminescent immunoassay using polystyrene beads coated with anti-ligand. Reagents include alkaline phosphatase-conjugated monoclonal murine anti-human IgE and a recombinant sheep monoclonal high-biotin affinity accessory reagent. Operates on IMMULITE 2000 Systems (e.g., XPi). Traceable to WHO 2nd IRP 75/502. Measuring interval 0.100–100 kU/L. Connectivity via IMMULITE 2000 system architecture.

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 peanut allergies. Prescription use only.

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

Submission Summary (Full Text)

{0} [LOGO] FDA U.S. FOOD & DRUG ADMINISTRATION ### 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY ### I Background Information: A 510(k) Number K260331 B Applicant Siemens Healthcare Diagnostics Products, Ltd. C Proprietary and Established Names IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13) D Regulatory Information | Product Code(s) | Classification | Regulation Section | Panel | | --- | --- | --- | --- | | DHB | Class II | 21 CFR 866.5750 Radioallergosorbent (RAST) immunological test system | IM - Immunology | ### II Submission/Device Overview: A Purpose for Submission:: New Device B Measurand: Allergen-specific Immunoglobulin E (IgE) to F13, Peanut C Type of Test: Quantitative, Chemiluminescent Immunoassay Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 www.fda.gov {1} ### III Intended Use/Indications for Use: #### A Intended Use(s): See Indications for Use below. #### B Indication(s) for Use: The IMMULITE 2000 3gAllergy Specific IgE Vantage assay is for in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers — for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE-mediated allergic disorders. The test results are to be used in conjunction with clinical findings and other laboratory tests. #### C Special Conditions for Use Statement(s): Rx - For Prescription Use Only #### D Special Instrument Requirements: IMMULITE 2000 XPi System ### IV Device/System Characteristics: #### A Device Description: The following materials are included in the IMMULITE 2000 3gAllergy Specific IgE Vantage: - • 3gAllergy Specific IgE Vantage Bead Pack, coated with anti-ligand - • 3gAllergy Specific IgE Vantage Accessory Reagent, monoclonal sheep anti-free biotin antibody in human serum albumin matrix, sodium azide, preservatives - • 3gAllergy Specific IgE Vantage Reagent Wedge, alkaline phosphatase (bovine calf intestine) conjugated to monoclonal murine anti-human IgE antibody in human/nonhuman serum buffer matrix - • 3gAllergy Specific IgE Adjustors, low and high levels of human IgE in nonhuman serum matrix, sodium azide, preservative - • 3gAllergy Specific IgE Vantage Adjustor Antibody, liquid, ready-to-use ligand-labeled polyclonal goat antihuman IgE antibody, preservative - • 3gAllergy Specific IgE (SPE) Universal Kit Controls, low and high levels of human IgE in a nonhuman serum matrix, sodium azide, preservative - • 3gAllergy Specific IgE Vantage Control Antibody, liquid, ready-to-use ligand-labeled polyclonal goat anti-human IgE antibody, preservative - • Specific Allergens, specific allergens in a protein-based buffer matrix, sodium azide preservative Peanut (F13) is Specific Allergen in IMMULITE 2000 Systems Peanut Allergen (F13) K260331 - Page 2 of 12 {2} # **B Principle of Operation:** This assay is a solid-phase, 2-step chemiluminescent immunoassay that exploits liquid phase kinetics in a bead format. The solid phase (bead) is coated with anti-ligand. The liquid phase consists of alkaline phosphatase (bovine calf intestine) conjugated to monoclonal murine anti-human IgE antibody in a human/nonhuman serum buffer matrix. In the first cycle, the patient sample and ligand-labeled specific allergen and accessory reagent are incubated together with the coated bead for 30 minutes. During this time, specific IgE in the sample binds to the ligand-labeled allergen, which in turn binds to the anti-ligand on the bead. Unbound material is then removed by centrifugal washes. In the second cycle, the enzyme conjugated monoclonal murine anti-human IgE antibody is added to the original reaction tube for an additional 30-minute incubation. The enzyme conjugated monoclonal murine anti-human IgE antibody binds to immobilized IgE. The unbound enzyme conjugate is removed by centrifugal washes. Finally, chemiluminescent substrate is added to the reaction tube containing the bead and the signal is generated in proportion to the bound enzyme. # **V Substantial Equivalence Information:** # **A Predicate Device Name(s):** IMMULITE 2000 Allergen Specific IgE Kit # **B Predicate 510(k) Number(s):** K013134 # **C Comparison with Predicate(s):** | Device & Predicate | K260331 (Candidate) | K013134 (Predicate) | | --- | --- | --- | | Device Trade Name | IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13) | IMMULITE 2000 Allergen Specific IgE Kit | | **General Device Characteristic Similarities** | | | | Intended Use/Indications For Use | The IMMULITE 2000 3gAllergy Specific IgE Vantage assay is for in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers — for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE-mediated allergic disorders. The test results are to be used in conjunction with clinical findings and other laboratory tests. | The IMMULITE 2000 Allergen Specific IgE is for in vitro diagnostic use with the IMMULITE 2000 Automated Immunoassay Analyzer – for the measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE-mediated allergic disorders. | K260331 - Page 3 of 12 {3} | Device & Predicate | K260331 (Candidate) | K013134 (Predicate) | | --- | --- | --- | | Technology | Chemiluminescent | Same | | Traceability | Traceable to the WHO 2^{nd} International Reference Preparation (75/502) | Same | | Sample type | Serum | Same | | Controls | Specific IgE Control Antibody and Specific IgE Universal Controls | Same | | Process Time | 65 minutes | Same | | Detection Antibody | Monoclonal murine anti-human IgE antibody conjugated to alkaline phosphatase in a human/nonhuman serum buffer matrix | Same | | Kit bead pack (solid phase) | Polystyrene bead coated with biotinylated methylated human serum albumin and streptavidin. | Same | | **General Device Characteristic Differences** | | | | Allergen | Whole Peanut Extract (F13) | Foods (F), Grass pollen (G), Weed pollen (W), Tree pollen (T), Epidermal and animal proteins (E), Microorganisms (M), Mites (D), Venoms and insects (I), Occupational (K) | | Accessory Reagent | Recombinant sheep monoclonal antibody high biotin affinity reagent | None | | Sample | 30 μL | 50 μL | ### VI Standards/Guidance Documents Referenced: The following Clinical and Laboratory Standards Institute (CLSI) guidelines and International Organization for Standardization (ISO) were used: - CLSI EP05-A3, Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline—Third Edition - CLSI EP06 2$^{nd}$ Edition, Evaluation of Linearity of Quantitative, Measurement Procedures - CLSI EP07 3$^{rd}$ Edition, Interference Testing in Clinical Chemistry - CLSI EP09c 3$^{rd}$ Edition, Measurement Procedure Comparison and Bias Estimation Using Patient Samples - CLSI EP17-A2, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline—Second Edition - CLSI EP25 2$^{nd}$ Edition, Evaluation of Stability of In Vitro Medical Laboratory Test Reagents K260331 - Page 4 of 12 {4} - CLSI EP28-A3c, Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline—Third Edition - CLSI EP37 1st Edition, Supplemental Tables for Interference Testing in Clinical Chemistry - CLSI EP39 1st Edition, A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests - 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 - ISO 17511:2020, In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples—Second Edition # VII Performance Characteristics (if/when applicable): # A Analytical Performance: # 1. Precision/Reproducibility: The studies were performed in accordance with CLSI guideline EP05-A3. Within Laboratory precision: The study was performed at a single site using one lot of the IMMULITE 2000 Systems Peanut Allergen reagent on one IMMULITE 2000 XPi instrument. Five levels of human serum samples were run in two replicates per run, two runs daily over the course of 21 days, resulting in a minimum of 84 datapoints for each sample. The data were analyzed for repeatability (within-run), between-run, between-day, and within-laboratory precision. The mean (kU/L), standard deviation (SD) (kU/L) and percent coefficient of variation (%CV) are summarized in table below. | Sample | N* | Mean (kU/L) | Within-Run (Repeatability) | | Between-Run | | Between-Day | | Within-Laboratory | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | | 1 | 84 | 0.19 | 0.02 | 8.6 | 0.01 | 5.2 | 0.01 | 4.8 | 0.02 | 11.2 | | 2 | 83 | 0.26 | 0.01 | 5.1 | 0.01 | 4.5 | 0.00 | 1.4 | 0.02 | 6.9 | | 3 | 83 | 0.43 | 0.02 | 4.9 | 0.00 | 0.0 | 0.02 | 3.8 | 0.03 | 6.2 | | 4 | 84 | 1.48 | 0.06 | 3.8 | 0.06 | 3.8 | 0.02 | 1.1 | 0.08 | 5.5 | | 5 | 84 | 83.20 | 3.19 | 3.8 | 1.23 | 1.5 | 1.00 | 1.2 | 3.56 | 4.3 | *Sample #2 and #3 each has one replicate excluded from analysis. # Lot-to-Lot Precision: The study was performed was performed using three lots of IMMULITE 2000 Systems Peanut Allergen reagent. Seven levels of serum samples were run in five replicates per run, one run per day over the course of five days, resulting in a total of 75 datapoints for each K260331 - Page 5 of 12 {5} sample. The data were analyzed for repeatability (within-run), between-day, between-reagent lot, and total precision. The mean (kU/L), standard deviation (SD) (kU/L) and percent coefficient of variation (%CV) are summarized in table below: | Sample | N | Mean (kU/L) | Within-Run (Repeatability) | | Between-Run | | Between-Lot | | Total | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | | 1 | 75 | 0.17 | 0.02 | 12.2 | 0.00 | 0.0 | 0.01 | 6.5 | 0.02 | 13.8 | | 2 | 75 | 0.27 | 0.02 | 6.3 | 0.01 | 3.9 | 0.00 | 0.0 | 0.02 | 7.4 | | 3 | 75 | 0.65 | 0.04 | 5.7 | 0.01 | 1.5 | 0.06 | 8.5 | 0.07 | 10.4 | | 4 | 75 | 1.42 | 0.07 | 5.2 | 0.04 | 2.9 | 0.12 | 8.5 | 0.15 | 10.3 | | 5 | 75 | 4.88 | 0.19 | 4.0 | 0.19 | 4.0 | 0.36 | 7.3 | 0.45 | 9.2 | | 6 | 75 | 25.10 | 1.27 | 5.1 | 0.00 | 0.0 | 1.30 | 5.2 | 1.81 | 7.2 | | 7 | 75 | 69.40 | 3.39 | 4.9 | 1.87 | 2.7 | 5.86 | 8.4 | 7.03 | 10.1 | Instrument-to-instrument precision: The study was performed using three IMMULITE 2000 XPi instruments with a single lot of the IMMULITE 2000 Systems Peanut Allergen reagent. Five levels of human serum samples were run in five replicates per run, one run per day over the course of five days, resulting in a total of 75 datapoints for each sample. The data was analyzed for repeatability (within-run), between-day, between-instrument, and reproducibility. The mean (kU/L), standard deviation (SD) (kU/L) and percent coefficient of variation (%CV) are summarized in the table below: | Sample | N | Mean (kU/L) | Within-Run (Repeatability) | | Between-Day | | Between-Instrument | | Total | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | | 1 | 75 | 0.15 | 0.02 | 11.6 | 0.00 | 0.0 | 0.01 | 3.5 | 0.02 | 12.1 | | 2 | 75 | 0.28 | 0.03 | 9.1 | 0.01 | 2.8 | 0.02 | 5.5 | 0.03 | 11.0 | | 3 | 75 | 0.60 | 0.03 | 5.3 | 0.00 | 0.0 | 0.01 | 1.1 | 0.03 | 5.5 | | 4 | 75 | 1.28 | 0.07 | 5.0 | 0.04 | 3.1 | 0.02 | 1.9 | 0.08 | 6.2 | | 5 | 75 | 78.90 | 4.17 | 5.3 | 2.73 | 3.5 | 0.00 | 0.0 | 4.99 | 6.3 | ## 2. Linearity: The linearity of the IMMULITE 2000 3gAllergy Specific IgE Vantage assay with Peanut Allergen was performed in accordance with CLSI guideline EP06, 2nd Edition. A fourteen (14) level dilution series was prepared by mixing the high serum samples and low levels serum samples in known ratios. The dilution levels were run in a minimum of three replicates on one IMMULITE 2000 XPi instrument using one reagent lot. The 'measured value' (mean kU/L) was compared to its predicted value for percentage of deviation using a linear regression analysis. This deviation was then compared to the allowable deviation from linearity (ADL). The regression results are summarized in the table below. | Range (kU/L) | Slope (95% CI) | Intercept (95% CI) | R² | | --- | --- | --- | --- | | 0.061 - 131 | 1.03 (1.00 - 1.06) | 0* | 0.996 | *95% CI is not applicable K260331 - Page 6 of 12 {6} The study results support the linearity of the claimed analytical measuring interval (AMI) for IMMULITE 2000 Systems Peanut Allergen: 0.100–100 kU/L. # 3. Analytical Specificity/Interference: # Inhibition study: Inhibition study was performed according to CLSI guidelines I/LA20 (3rd Edition) to determine the analytical specificity of the IMMULITE 2000 3gAllergy Specific IgE Vantage assay with Peanut Allergen by competitive inhibition. One related allergen (unbiotinylated F13) and three unrelated allergens, including D1 (Dermatophagoides Pteronyssinus), E2 (Dog Epithelium), and M6 (Alternaria Tenuis) were tested. The related allergen was diluted to create five dilutions: 1:5, 1:25, 1:125, 1:625, and 1:312, each evaluated for dose-dependent inhibition. The unrelated allergens were prepared and tested at a single concentration that is at least 10 folds higher than that of the related allergen at which greater than 85% inhibition was achieved. The related or unrelated allergen was spiked 1:1 into aliquots of a positive Peanut Allergen human serum sample (10.4 kU/L). Each sample was assayed in duplicate using one reagent lot on one IMMULITE 2000 XPi instrument. The results of the inhibition studies for the related allergen (F13) showed 82%, 92% and 97% inhibition at a concentration of 4, 20 and 100 μg/mL, respectively. The inhibition studies, using unrelated allergens at a test concentration of 100 μg/mL did not show any significant inhibition. The inhibition studies indicate that the IMMULITE 2000 3gAllergy Specific IgE Vantage assay with Peanut Allergen contains the immunologically relevant allergen. # Interference: Interference study was performed according to CLSI guidelines EP07, 3rd Edition and EP37, 1st Edition to determine the effect of various potential endogenous and exogenous interfering substances on the IMMULITE 2000 3gAllergy Specific IgE Vantage assay with Peanut Allergen. Two serum sample pools with target specific IgE concentrations of approximately 0.300–0.699 kU/L and 0.700–3.50 kU/L were spiked with and without the interferent and measured in seven replicates using one reagent lot on a single IMMULITE 2000 XPi instrument. The percent difference was determined by comparing the result of the sample spiked with interferent to that of control sample without the interferent. The percent difference between the mean spiked sample value and the mean control value was calculated [100* (test mean – control mean) / control mean] and an interference within ≤ 10% difference was considered non-significant. # a) Endogenous Substance Interference: The following potential endogenous interfering substances were tested using IMMULITE 2000 3gAllergy Specific IgE Vantage assay with Peanut Allergen. No significant interference was found for each potential interfering substance at the concentrations listed below. K260331 - Page 7 of 12 {7} | Endogenous Substance | Concentration | | --- | --- | | Albumin | 120 g/L | | Bilirubin (conjugated) | 40 mg/dL | | Bilirubin (unconjugated) | 40 mg/dL | | Hemoglobin | 1,000 mg/dL | | Intralipid | 3,000 mg/dL | | Rheumatoid Factor | 500 IU/mL | | HAMA* Type I | 87 ng/mL | | HAMA Type II | 107 ng/mL | * human anti-mouse antibodies # b) Exogenous Substance Interference: The following potential exogenous interfering substances were tested using IMMULITE 2000 3gAllergy Specific IgE Vantage assay with Peanut Allergen. No significant interference was found each potential interfering substance at the concentrations listed below. | Exogenous Substance | Concentration | | --- | --- | | diphenhydramine | 19.5 μmol/L | | methylprednisolone | 7,830 ng/mL | | ranitidine | 33.4 μmol/L | | omalizumab | 0.12 mg/mL | Biotin interference: Significant interference was found for biotin at high concentrations as listed in the table below. | Sample (kU/L) | % Bias | | | | | | --- | --- | --- | --- | --- | --- | | | Biotin concentration (ng/mL) | | | | | | | **500** | **600** | **1,000** | **1,500** | **3,510** | | 0.44 | -6.5% | 0.5% | -5.4% | -10.8% | -77.5% | | 1.3 | 0.8% | -0.8% | -6.2% | -5.4% | -92.3% | The IMMULITE 2000 3gAllergy Specific IgE Vantage assay with Peanut Allergen 'instructions for use' contains the following statement of limitation "testing specimens from patients taking biotin may lead to falsely depressed results. Therefore, do not use this device in patients with IgE-mediated allergic disorders, unless it is confirmed that the patient is not taking high doses of biotin." # Cross-reactivity: The potential cross-reactivity of the following non-IgE (IgA, IgD, IgG, and IgM) was evaluated using IMMULITE 2000 3gAllergy Specific IgE Vantage assay with Peanut Allergen according to the CLSI guideline EP07, 3rd Edition. No significant cross-reactivity (percent difference ≤ 10%) was found for each cross-reactant tested at the concentration listed below. K260331 - Page 8 of 12 {8} | Cross-Reactant | Concentration | | --- | --- | | Immunoglobulin G | 2000 mg/dL | | Immunoglobulin A | 500 mg/dL | | Immunoglobulin M | 400 mg/dL | | Immunoglobulin D | 240 mg/L | # 4. Detection Capability: CLSI guideline EP17-A2 was followed to determine the Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantitation (LoQ) for the IMMULITE 2000 3gAllergy Specific IgE Vantage assay with Peanut Allergen. The LoB was determined by testing four analyte undetectable serum samples over five days, one runs per day, five replicates per run using two reagent lots on one IMMULITE 2000 XPi instrument for a total of 100 replicates per reagent lot. The LoB for each reagent lot was calculated using the non-parametrically at the 95th percentile of all measurements of the blank samples. The LoB was calculated separately for each reagent lot, and the highest value was taken as the LoB value. The LoB values from the two lots were all 0.0 kU/L. The claimed LoB is 0.0 kU/L. The LoD was determined by testing four serum samples diluted with serum samples containing low levels of measurand were tested over five days, one run per day, five replicates per run using two reagent lots on IMMULITE 2000 XPi instrument for a total of 100 replicates per reagent lot. The LoD was analyzed by using a parametric method approach. The LoD was calculated separately for each reagent lot, and the highest value was taken as the LoD value. The LoQ values from the two lots were 0.036 kU/L and 0.044 kU/L. The claimed LoD for IMMULITE 2000 3gAllergy Specific IgE Vantage assay with Peanut Allergen on the IMMULITE 2000 XPi System is 0.044 kU/L. The LoQ was determined by testing nine serum samples diluted with serum samples containing low levels of measurand over five days, two runs per day, five replicates per run using two reagent lots on one IMMULITE 2000 XPi instrument for a total of 50 replicates per sample per reagent lot. For each reagent lot, the within-laboratory precision over five days, expressed as %CV, was plotted against the mean measurand concentration for each sample. The LoQ was defined as the level at which the %CV of the within-laboratory imprecision of no more than 20%. The LoQ values from the two lots were 0.052 kU/L and 0.079 kU/L .The claimed LoQ for the IMMULITE 2000 3gAllergy Specific IgE Vantage assay with Peanut Allergen results on the IMMULITE 2000 XPi System is 0.1 kU/L. # 5. Assay Reportable Range: The analytical measuring interval (AMI) for the IMMULITE 2000 3gAllergy Specific IgE Vantage assay with Peanut Allergen on the IMMULITE 2000 XPi System is 0.100–100 kU/L. Values below the low limit of AMI are reported as <0.1 kU/L. Values above the upper limit of AMI are reported as > 100 kU/L. K260331 - Page 9 of 12 {9} 6. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods): Traceability: The calibrators and controls are traceable to the World Health Organization (WHO) 2nd International Reference Preparation 75/502 reference standard for human IgE. Kit Stability: The stability of the IMMULITE 2000 3gAllergy Specific IgE Vantage assay with Peanut Allergen reagent kit was determined according to CLSI guideline EP25, 2nd Edition. a) Shelf-life stability: A real-time stability study for the IMMULITE 2000 3gAllergy Specific IgE Vantage assay with Peanut Allergen stored at 2–8°C is on-going by testing four samples (one negative and three positive samples) at Day 0 and at scheduled timepoints of 1, 2, 7, 30, 62, 120, 183, 273, 330, 366, and 391 days in four replicates per sample using three reagent kit lots on one IMMULITE 2000 XPi instrument. The current data support stability of the IMMULITE 2000 3gAllergy Specific IgE Vantage assay with Peanut Allergen for 12 months at 2–8°C. b) On-board and Open vial stability An on-board and accessory reagent open vial stability study was performed on one IMMULITE 2000 XPi instrument using four samples (one negative and three positive samples) and one lot of IMMULITE 2000 3gAllergy Specific IgE Vantage assay with Peanut Allergen. The testing was performed for each sample in four replicates at Day 0 and scheduled timepoints of 1, 2, 7, 14, 28, 56, 84, 87, 90, 91 days (in-use) and fresh reagent lots were used to assay each sample. The accessory reagent was aliquoted and left uncapped for ≥ 7 days at room temperature (15-28°C) to simulate aging. The data supports stability of the IMMULITE 2000 3gAllergy Specific IgE Vantage assay with Peanut Allergen onboard and accessory reagent open vial stability for 90 days. 7. Assay Cut-Off: Not applicable # B Comparison Studies: 1. Method Comparison with Predicate Device: CLSI guidelines EP09c 3rd Edition and I/LA20 3rd Edition were followed to compare the IMMULITE 2000 3gAllergy Specific IgE Vantage with Peanut Allergen to the IMMULITE 2000 3gAllergy Specific IgE Universal Kit with Peanut Allergen. A total of 87 serum samples with specific IgE concentrations falling within the AMI (0.16–81.3 kU/L) were tested across K260331 - Page 10 of 12 {10} three days with one reagent lot of IMMULITE 2000 3gAllergy Specific IgE Vantage assay with Peanut Allergen (candidate) and one reagent lot of IMMULITE 2000 3gAllergy Specific IgE Universal Kit with Peanut Allergen (predicate) on the IMMULITE 2000 XPi instrument. The comparison between paired measurements was analyzed using Passing-Bablok method. The results are summarized in the table below. | N | Range (kU/L)* | Slope (95% CI) | Intercept (95% CI) | R | | --- | --- | --- | --- | --- | | 87 | 0.16–81.3 | 0.95 (0.92, 1.00) | -0.089 (-0.141, -0.047) | 0.99 | # 2. Matrix Comparison: Not applicable # C Clinical Studies: # 1. Clinical Sensitivity and Specificity The clinical performance was evaluated by comparing the test results from a study cohort including 132 atopic peanut-allergic individuals (subjects with a clinical history of symptoms consistent with an IgE-mediated food allergic reaction upon exposure to peanut as diagnosed by a physician) and 85 atopic with no peanut allergy individuals (participants having no IgE-mediated allergic responses to peanut, and having clinical history of IgE-mediated allergic responses to foods other than peanut or to environmental allergens as diagnosed by a physician). The IMMULITE 2000 3gAllergy Specific IgE Vantage assay results are expressed as positive or negative using a cut-off of 0.35 kU/L. The clinical sensitivity and clinical specificity, with 95% confidence intervals (CI), for IMMULITE 2000 Specific IgE Vantage assay with Peanut Allergen assay are summarized in the following table: | | Clinical Diagnosis | | | | | --- | --- | --- | --- | --- | | | | Atopic Peanut | Atopic Non-Peanut | Total | | IMMULITE 2000 Specific IgE Vantage, Peanut Allergen | Positive (≥0.35 kU/L) | 110 | 5 | 115 | | | Negative (<0.35 kU/L) | 22 | 80 | 102 | | | Total | 132 | 85 | 217 | | Clinical Sensitivity: 83% (110/132) (95% CI: 76 – 89%) Clinical Specificity: 94% (80/85) (95% CI: 87 – 97%) | | | | | # 2. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable): Not Applicable K260331 - Page 11 of 12 {11} # 3. Clinical Cut-Off: The clinical cut-off of the assay is 0.35 kU/L. The interpretation of results of the assay uses the following classification system: | Class | Concentration (kU/L) | Interpretation | | --- | --- | --- | | 0* | <0.35 | Negative | | I | 0.35 to 0.69 | Positive with increasing sIgE concentration | | II | 0.70 to 3.49 | | | III | 3.50 to 17.49 | | | IV | 17.50 to 52.49 | | | V | 52.50 to 99.99 | | | VI | ≥100 | | * Class 0 in the standard system signifies not detectable by second-generation assays # D Expected Values/Reference Range: The reference interval for the IMMULITE 2000 3gAllergy Specific IgE Vantage for Peanut Allergen (F13) was determined in accordance with CLSI EP28-A3c based on the test results using 108 apparently healthy (non-atopic) individuals. All samples were tested below 0.35 kU/L. Each laboratory should establish its own expected value/reference range. # VIII Proposed Labeling: The labeling supports the finding of substantial equivalence for this device. # IX Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. K260331 - Page 12 of 12
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