← Product Code [DHB](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHB) · K091984

# IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6 (K091984)

_Siemens Medical Solutions Diagnostics · DHB · Oct 28, 2009 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHB/K091984

## Device Facts

- **Applicant:** Siemens Medical Solutions Diagnostics
- **Product Code:** [DHB](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHB.md)
- **Decision Date:** Oct 28, 2009
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5750
- **Device Class:** Class 2
- **Review Panel:** Immunology

## Indications for Use

For in vitro diagnostic use with the IMMULITE® 2000 Analyzer - for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE-mediated allergic disorders.

## Device Story

The IMMULITE® 2000 3gAllergy™ Specific IgE assay is a solid-phase, two-step, chemiluminescent immunoassay. It utilizes liquid-phase kinetics in a bead format where allergens are covalently bound to a soluble amino acid co-polymer matrix labeled with a ligand. The device processes human serum samples on the IMMULITE® 2000 Analyzer. The assay measures allergen-specific IgE levels, providing quantitative results that assist clinicians in diagnosing IgE-mediated allergic disorders. The system is intended for use in clinical laboratory settings by trained personnel. By quantifying specific IgE, the device helps healthcare providers identify sensitization to specific allergens, supporting clinical decision-making regarding allergy management and treatment.

## Clinical Evidence

Clinical performance was evaluated by testing serum samples from atopic and non-atopic individuals for each of the 27 allergens. Sample sizes ranged from 130 to 190 per allergen. Clinical sensitivity ranged from 32% (Haddock) to 98% (Chestnut), and specificity ranged from 92% (Lima Bean) to 100% (Black pepper, Cheese-Mold Type, Chocolate, Lamb, Pear, Pineapple, Trout, Turkey meat). Literature support was provided for allergens with lower clinical sensitivity.

## Technological Characteristics

Solid-phase, two-step chemiluminescent immunoassay. Uses liquid-phase kinetics with allergens covalently bound to a soluble amino acid co-polymer matrix. Form factor is a bead-based system for use on the IMMULITE® 2000 Analyzer. Quantitative measurement of IgE. No specific software algorithm class or connectivity details provided beyond standard analyzer operation.

## Regulatory Identification

A radioallergosorbent immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the allergen antibodies (antibodies which cause an allergic reaction) specific for a given allergen. Measurement of specific allergen antibodies may aid in the diagnosis of asthma, allergies, and other pulmonary disorders.

## Special Controls

*Classification.* Class II (special controls). The device, when intended to detect any of the allergens included in Table 1 in this paragraph, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.    Table 1—Class II Exempt Allergens Under § 866.5750—Radioallergosorbent (RAST) Immunological Test Systems
  Allergen code Allergen product Source  (taxonomical name)   Grass Pollens  g1 Sweet vernal grass  Anthoxanthum odoratum.  g3 Cocksfoot grass, Orchard grass  Dactylis glomerata.  g4 Meadow fescue  Festuca elatior.  g5 Rye-grass (perennial rye grass)  Lolium perenne.  g7 Common reed (common reed grass)  Phragmites communis.  g8 Meadow grass, Kentucky blue (June grass)  Poa pratensis.  g9 Redtop, Bentgrass  Agrostis stolonifera ,Agrostis gigantea (Agrostis alba ). g11 Brome grass  Bromus inermis.  g12 Cultivated rye (cultivated rye grass)  Secale cereale.  g13 Velvet grass  Holcus lanatus.  g14 Cultivated oat (cultivated oat grass)  Avena sativa.  g15 Cultivated wheat (cultivated wheat grass)  Triticum aestivum (Triticum spp.). g16 Meadow foxtail (meadow foxtail grass)  Alopecurus pratensis.  g17 Bahia grass  Paspalum notatum.  g24 Wheat grass, Western  Agropyron smithii (Elymus smithii ). g30 Bluegrass, annual  Poa annua.  g70 Wild rye grass  Elymus triticoides Elymus condensatus.  g71 Canary grass  Phalaris arundinacea.  g201 Barley, cultivated  Hordeum vulgare.  g202 Maize, corn (cultivated corn)  Zea mays.  g203 Salt grass  Distichlis spicata.  g204 False oat-grass  Arrhenatherum elatius.  g216 Cyn d 1  Cynodon dactylon.  g701 Phl p 1.0102, Phl p 5.0101  Phleum pratense.  g702 Phl p 7.0101  Phleum pratense.  g703 Phl p 12.0101  Phleum pratense.   Weed Pollens  w2 Western ragweed  Ambrosia psilostachya.  w4 False ragweed  Ambrosia acanthicarpa (Franseria acanthicarpa ). w5 Wormwood  Artemisia absinthium Artemisia annua.  w6 Mugwort  Artemisia vulgaris.  w7 Marguerite, ox-eye daisy  Chrysanthemum leucanthemum.  w8 Dandelion  Taraxacum vulgare ,Taraxacum officinale.  w9 Plantain (English), Ribwort  Plantago lanceolata.  w10 Goosefoot, lamb's quarters  Chenopodium album.  w11 Saltwort (prickly), Russian thistle  Salsola kali (Salsola pestifer ). w12 Goldenrod  Solidago virgaurea (Solidago spp.). w13 Cocklebur, common  Xanthium commune.  w14 Common pigweed (rough pigweed)  Amaranthus retroflexus.  w15 Scale, Lenscale  Atriplex lentiformis.  w16 Rough marsh elder  Iva ciliate ,Iva annua.  w17 Firebush (Kochia)  Kochia scoparia.  w18 Sheep sorrel  Rumex acetosella.  w19 Wall pellitory  Parietaria officinalis.  w20 Nettle (Common stinging nettle)  Urtica dioica.  w21 Wall pellitory  Parietaria judaica.  w22 Japanese hop (careless weed)  Humulus japonicas (Humulus scandens ). w23 Yellow dock, Yellow dockweed  Rumex crispus.  w24 Spiny pigweed  Amaranthus spinosus.  w27 Carnation  Dianthus spp. w28 Rose  Rosa rugosa.  w33 Clover  Trifolium pratense.  w35 Mexican tea  Chenopodium ambrosioides.  w36 Rabbit bush  Ambrosia deltoidea (Franseria deltoides ). w37 Salt bush, annual  Atriplex wrightii.  w39 Water hemp, Western  Amaranthus rudis (Acnida tamariscina ). w41 Burrobrush  Hymenoclea salsola.  w42 Poverty weed  Baccharis neglecta.  w43 Common sagebrush  Artemisia tridentata.  w45 Alfalfa  Medicago sativa.  w46 Dog fennel  Eupatorium capillifolium.  w53 Geranium  Geranium spp. w67 Groundsel bush  Baccharis halimifolia.  w69 Iodine bush  Allenrolfea occidentalis.  w70 Ragweed, slender  Ambrosia confertiflora.  w75 Wing scale (wingscale)  Atriplex canescens.  w82 Careless weed  Amaranthus palmeri ,Amaranthus hybridus.  w90 Japanese hop  Humulus japonicas (Humulus scandens ). w203 Rape (rape pollen)  Brassica napus.  w204 Sunflower  Helianthus annuus.  w206 Camomile  Matricaria chamomilla.  w207 Lupin  Lupinus spp. w210 Sugar-beet  Beta vulgaris.  w211 Par j 2.0101  Parietaria judaica.  w231 Art v 1  Artemisia vulgaris (Mugwort). w232 Sal k 1  Salsola kali.  w233 Art v 3  Artemisa vulgaris (LTP, Mugwort). w234 Pla l 1  Plantago lanceolata.  w235 Che a 1.0101  Chenopodium album.  w236 Mer a 1.0101  Mercurialis annua.  a753 Art v 1  Artemisia vulgaris (Mugwort weed).  Tree Pollens  t1 Box-elder (Maple)  Acer negundo ,Acer saccharum.  t2 Gray alder, speckled alder (alder)  Alnus incana.  t4 Hazel, hazelnut  Corylus avellana ,Corylus americana.  t5 American beech (beech)  Fagus grandifolia (Fagus americana ). t6 Mountain juniper, Mountain cedar  Juniperus ashei (Juniperus sabinoides ). t8 Elm  Ulmus americana.  t9 Olive  Olea europaea.  t10 Walnut  Juglans californica ,Juglans nigra.  t11 Maple leaf sycamore, London plane, Plane tree  Platanus acerifolia.  t61 Sycamore  Platanus occidentalis.  t12 Willow  Salix caprea ,Salix nigra.  t14 Cottonwood (Eastern Cottonwood/Black Cottonwood)  Populus deltoides.  t15 White ash  Fraxinus americana.  t16 White pine  Pinus strobus.  t18 Eucalyptus, gum-tree  Eucalyptus globulus (Eucalyptus spp.). t19/t26 Acacia  Acacia longifolia (Acacia spp.). t20 Mesquite  Prosopis glandulosa/ Prosopis juliflora.  t21 Melaleuca, cajeput tree  Melaleuca quinquenervia (Melaleuca leucadendron ). t22 Pecan, hickory  Carya illinoinensis (Carya pecan ). t23 Italian/Mediterranean/funeral cypress  Cupressus sempervirens.  t24 Japanese cypress  Chamaecyparis obtusa (Chamaecyparis spp.). t25 Ash  Fraxinus excelsior.  t27 Maple, red  Acer rubrum.  t29 Acacia  Acacia spp. t30 Birch, white  Betula populifolia.  t32 Willow, black  Salix nigra.  t33 Ash, Arizona  Fraxinus velutina.  t35 Cedar, salt  Tamarix gallica.  t37 Bald cypress (white bald cypress)  Taxodium distichum.  t38 Elm, Chinese/Siberian  Ulmus pumila.  t40 Hazelnut tree  Corylus americana.  t41 White hickory  Carya alba (Carya tomentosa ). t42 Oak, red  Quercus rubra.  t43 Loblolly pine  Pinus taeda.  t44 Hackberry  Celtis occidentalis.  t45 Cedar elm  Ulmus crassifolia.  t47 Juniper, one seed  Juniperus monosperma.  t48 Pine, lodgepole  Pinus contorta.  t49 Pine, ponderosa  Pinus ponderosa.  t50 Beech, European  Fagus sylvatica.  t51 Tree of Heaven  Ailanthus altissima.  t52 Western white pine  Pinus monticola.  t54 Russian olive  Elaeagnus angustifolia.  t55 Scotch broom  Cytisus scoparius.  t56 Bayberry  Myrica cerifera.  t57 Red cedar  Juniperus virginiana.  t60 Western juniper  Juniperus occidentalis.  t61 Sycamore  Platanus occidentalis.  t70 Mulberry (white mulberry)  Morus alba.  t71 Red mulberry  Morus rubra.  t72 Queen palm  Arecastrum romanzoffiamon.  t73 Australian pine  Casuarina equisetifolia.  t77 Oak mix (red, white, black)  Quercus spp. t80 Japanese cypress  Chamaecyparis obtusa.  t81 Japanese alder  Alnus japonica.  t83 Mango tree  Mangifera indica.  t90 Walnut, black  Juglans nigra.  t96 Poplar, white (poplar)  Populus alba.  t103/t218 Virginia live oak (live oak)  Quercus virginiana.  t105 Pepper tree  Schinus molle.  t110 Orange tree  Citrus sinensis.  t201 Spruce, Norway spruce  Picea abies (Picea excelsa ). t202 Alder, smooth  Alnus incana spp.Rugosa (Alnus rugosa ). t203 Horse chestnut  Aesculus hippocastanum.  t205 Elder  Sambucus nigra.  t206 Chestnut  Castanea sativa.  t207 Douglas fir  Pseudotsuga menziesii (Pseudotsuga taxifolia ). t208 Linden  Tilia cordata.  t209 Horn beam  Carpinus betulus.  t210 Privet  Ligustrum vulgare.  t211 Sweet gum  Liquidambar styraciflua.  t212 Cedar  Libocedrus decurrens.  t213 Pine  Pinus radiata.  t214 Date palm  Phoenix canariensis.  t215 Lilac  Syringa vulgaris.  t217 Pepper tree  Schinus molle.  t217 Red alder  Alnus rubra.  t218 Virginia live oak  Quercus virginiana.  t218 Bayberry (bayberry/sweet gale)  Myrica gale.  t219 Palo verde  Cercidium floridum.  t219 Red cedar  Juniperus virginiana.  t220 Bet v 4  Betula verrucosa (Birch). t221 Bet v 2.0101, Bet v 4  Betula verrucosa (Birch). t222 Cypress (Arizona cypress)  Cupressus arizonica.  t223 Oil palm  Elaeis guineensis.  t224 Ole e 1  Olea europaea.  t225 Bet v 6  Betula verrucosa (Birch). t226 Cup a 1  Cupressus arizonica.  t227 Ole e 7  Olea Europaea.  t228 Aspen, quaking  Populus tremuloides.  t229 Eastern hemlock  Tsuga canadensis.  t230 Redwood (sequoia)  Sequoia sempervirens.  t232 Pussy willow  Salix discolor.  t240 Ole e 9.0101  Olea Europaea.  t241 Pla a 1.0101  Platanus acerifolia.  t242 Pla a 2  Platanus acerifolia.  t243 Pla a 3.0101  Platanus acerifolia.  t244 Cor a 1.0103  Corylus avellana.  t245 Aln g 1.0101  Alnus glutinosa.  t246 Cry j 1  Cryptomeria japonica.  t280 Locust tree  Robinia pseudoacacia.  t401 Brazilian peppertree  Schinus terebinthifolius.  t402 Mastic tree  Pistacia lentiscus.  t404 Tree of heaven  Ailanthus altissima.  t406 Date palm  Phoenix dactylifera.  a482 Ole e 1  Olea europaea (Olive Oil).  Mites  d207 Blo t 5.0101  Blomia tropicalis.  d208 Lep d 2.0101  Lepidoglyphus destructor.   Microorganisms, Molds, Yeast  m1  Penicillium chrysogenum (Penicillium notatum ) Penicillium chrysogenum (Penicillium notatum ). m2  Cladosporium herbarum (Hormodendrum ) Cladosporium herbarum (Hormodendrum ). m3  Aspergillus fumigatus  Aspergillus fumigatus.  m4  Mucor racemosus  Mucor racemosus.  m5  Candida albicans  Candida albicans.  m7  Botrytis cinerea  Botrytis cinerea.  m8  Drechslera halodes (Setomelanomma rostrata, Helminthosporium halodes, Helminthosporium interseminatum ) Drechslera halodes (Setomelanomma rostrata, Helminthosporium halodes.  m9  Fusarium moniliforme (Fusarium proliferatum ) Fusarium moniliforme (Fusarium proliferatum ). m10  Stemphylium botryosum  Stemphylium herbarum (Stemphylium botryosum ). m11  Rhizopus nigricans  Rhizopus nigricans.  m12  Aureobasidium pullulans  Aureobasidium pullulans.  m13  Phoma betae  Phoma betae.  m14  Epicoccum purpurascens  Epicoccum purpurascens (Epicoccum nigrum ). m15  Trichoderma viride  Trichoderma viride.  m16  Curvularia lunata  Curvularia lunata ,Curvularia specifera (K923044 ). m17  Cladosporium fulvum  Cladosporium fulvum.  m18  Fusarium culmorum  Fusarium culmorum.  m19  Aspergillus versicolor  Aspergillus versicolor.  m20  Mucor mucedo  Mucor mucedo.  m21  Aspergillus clavatus  Aspergillus clavatus.  m22  Micropolyspora faeni  Saccharopolyspora rectivirgula (Micropolyspora faeni ). m23  Thermoactinomyces vulgaris  Thermoactinomyces vulgaris.  m24  Stachybotrys atra  Stachybotrys chartarum (Stachybotrys atra ). m24  Paecilomyces spp Paecilomyces spp. m25  Aspergillus versicolor  Aspergillus versicolor.  m25  Penicillium brevicompactum  Penicillium brevicompactum.  m26  Cladosporium cladosporioides  Cladosporium cladosporioides.  m26  Penicillium citrinum  Penicillium citrinum.  m27  Penicillium spp Penicillium spp. m29  Aspergillus repens  Aspergillus repens.  m30  Penicillium roqueforti  Penicillium roqueforti.  m32  Cladosporium cladosporioides  Cladosporium cladosporioides.  m34  Serpula lacrymans  Serpula lacrymans.  m36  Aspergillus terreus  Aspergillus terreus.  m37  Trichophyton mentagrophytes  Trichophyton mentagrophytes.  m40  Aspergillus amstelodami  Aspergillus amstelodami.  m43  Saccharomyces Carlsberg  Saccharomyces carlsbergensis.  m44  Saccharomyces cerevisiae  Saccharomyces cerevisiae.  m45  Hormodendrum hordei  Hormodendrum hordei.  m46  Bipolaris spicifera  Bipolaris spicifera.  m47  Aspergillus nidulans  Aspergillus nidulans.  m48  Aspergillus oryzae  Aspergillus oryzae.  m49  Fusarium oxysporum  Fusarium oxysporum.  m50  Micropolyspora faeni  Saccharopolyspora rectivirgula (Micropolyspora faeni ). m51  Thermoactinomyces vulgaris  Thermoactinomyces vulgaris.  m53  Microspora canis  Microsporum canis (Microspora canis ). m54  Aspergillus flavus  Aspergillus flavus.  m63  Helminthosporium intersemin  Helminthosporium intersemin.  m66  Mucor plumbeus  Mucor plumbeus.  m67  Mycogone  Mycogone perniciosa.  m68  Nigrospora oryzae  Nigrospora oryzae.  m69  Rhodotorula  Rhodotorula rubra (Rhodotorula mucilaginosa ). m70  Malassezia furfur (Pityrosporum orbiculare ) Malassezia furfur (Pityrosporum orbiculare ). m71  Spondylocladium  Spondylocladium spp. m72  Epidermophyton  Epidermophyton floccosum.  m73  Epicoccum nigrum  Epicoccum purpurascens (Epicoccum nigrum ). m80  Staphylococcal enterotoxin A (Sta a SEA ) Staphylococcus aureus.  m80  Helminthosporium spp Helminthosporium spp. m81  Staphylococcal enterotoxin B (Sta a SEB ) Staphylococcus aureus.  m88  Stemphylium solani  Stemphylium solani.  m93  Gliocladium fimbriatum  Gliocladium fimbriatum.  m94  Phycomyces blakesleeanus  Phycomyces blakesleeanus.  m201  Tilletia tritici (Ustilago nuda, Ustilago tritici ) (Barley smut) Tilletia tritici (Ustilago nuda, Ustilago tritici ). m202  Acremonium kiliense (Cephalosporium acremonium ) Acremonium kiliense (Cephalosporium acremonium ). m203  Trichosporon pullulans  Trichosporon pullulans.  m204  Ulocladium chartarum  Ulocladium chartarum.  m205  Trichophyton rubrum  Trichophyton rubrum.  m207  Aspergillus niger  Aspergillus niger.  m208  Chaetomium globosum  Chaetomium globosum.  m209  Penicillium frequentans  Penicillium glabrum (Penicillium frequentans ). m209  Stachybotrys chartarum  Stachybotrys chartarum (Stachybotrys atra ). m210  Trichophyton mentagrophytes var. goetzii  Trichophyton mentagrophytes var. goetzii.  m211  Trichophyton mentagrophytes var. interdigitale  Trichophyton mentagrophytes var. interdigitale.  m211 Oat smut  Ustilago avenae.  m212  Micropolyspora faeni  Saccharopolyspora rectivirgula (Micropolyspora faeni ). m212  Geotrichum candidum  Geotrichum candidum.  m213 Bermuda grass smut  Ustilago cynodontis.  m214 Johnson grass smut  Sphacelotheca cruenta.  m215 Corn smut  Ustilago maydis.  m218 Asp f 1.0101  Aspergillus fumigatus.  a3050 Asp r 1  Aspergillus restrictus.  m219 Asp f 2  Aspergillus fumigatus.  m220 Asp f 3.0101  Aspergillus fumigatus.  m221 Asp f 4  Aspergillus fumigatus.  m222 Asp f 6.0101  Aspergillus fumigatus.  m223  Staphylococcal enterotoxin C (Sta a SEC ) Staphylococcus aureus.  m224  Staphylococcal enterotoxin D (Sta a SED ) Staphylococcus aureus.  m226  Staphylococcal enterotoxin TSST (Sta a TSST ) Staphylococcus aureus.  m227  Malassezia spp. (Pityrosporum spp.) Malassezia spp. (Pityrosporum spp.). m228  Aspergillus flavus.   m229 Alt a 1.0101  Alternaria alternata (Alternaria tenuis ). m230 Alt a 6.0101  Alternaria alternata (Alternaria tenuis ). m231 Cla h 8.0101  Cladosporium herbarum (Hormodendrum ). m300  Eurotium spp Eurotium spp. m304  Aspergillus oryzae  Aspergillus oryzae.  m305  Penicillium brevicompactum  Penicillium brevicompactum.  m309  Aspergillus terreus  Aspergillus terreus.  m310  Aspergillus nidulans  Aspergillus nidulans.  m311  Aspergillus flavus  Aspergillus flavus.  m312  Aspergillus clavatus  Aspergillus clavatus.   Epidermal & Animal  e6 Guinea pig epithelium  Cavia porcellus.  e7 Pigeon droppings  Columba palumbus ,Columba livia.  e25 Chicken serum  Gallus domesticus (Gallus gallus domesticus; Gallus spp.). e26 Parrot serum  Psittacoidea spp. e62 Camel  Camelus dromedaries.  e70 Goose feathers  Anser anser.  e71 Mouse epithelium  Mus musculus (Mus spp.). e73 Rat epithelium  Rattus norvegicus.  e74 Rat urine proteins  Rattus norvegicus ,Rattus rattus.  e75 Rat serum proteins  Rattus norvegicus ,Rattus rattus.  e76 Mouse serum proteins  Mus musculus (Mus spp.). e77 Budgerigar droppings  Melopsittacus undulatus.  e78 Budgerigar feathers  Melopsittacus undulatus.  e79 Budgerigar serum proteins  Melopsittacus undulatus.  e80 Goat epithelium  Capra hircus.  e81 Sheep epithelium  Ovis aries (Ovis spp.). e82 Rabbit epithelium  Oryctolagus cuniculus (Oryctolagus spp.). e83 Swine epithelium  Sus scrofa (Sus scrofa domesticus; Sus spp.). e84 Hamster epithelium  Cricetus cricetus, Mesocricetus auratus, and Phodopus sungorus.  e85 Chicken feathers  Gallus domesticus (Gallus gallus domesticus; Gallus spp.). e86 Duck feathers  Anas platyrhynchos.  e87 Rat epithelium, serum proteins, and urine proteins  Rattus norvegicus Rattus rattus.  e88 Mouse epithelium, serum proteins, and urine proteins (mouse)  Mus musculus (Mus spp.). e89 Turkey feathers  Meleagris gallopavo.  e90 Budgerigar serum proteins, feathers, and droppings  Melopsittacus undulatus.  e91 Pigeon serum proteins, feathers, and droppings  Streptopelia roseogrisea ,Psittacidae spp. e92 Parrot serum proteins, feathers, and droppings  Ara spp. e93 Pigeon serum proteins  Streptopelia roseogrisea.  e94 Fel d 1.0101  Felis domesticus.  a345 Fel d 1  Felis domesticus.  e98 Parrot droppings  Psittacoidea spp. e101 Can f 1.0101  Canis familiaris (Canis domesticus ). a174 Can f 1  Canis familiaris (Canis domesticus ). e102 Can f 2.0101  Canis familiaris (Canis domesticus ). e196 Parakeet feathers  Nymphicus hollandicus.  e197 Parakeet droppings  Nymphicus hollandicus.  e198 Parakeet serum  Nymphicus hollandicus.  e199 Canary bird serum  Serinus canarius.  e200 Canary bird droppings  Serinus canarius.  e201 Canary bird feathers (Canary feathers)  Serinus canarius.  e202 Reindeer epithelium  Rangifer tarandus.  e203 Mink epithelium  Mustela spp. e204 Bos d 6  Bos domesticus (Bos taurus; Bos spp.). e205 Horse, serum proteins  Equus caballus (Equus spp.). e206 Rabbit, serum proteins  Oryctolagus cuniculus (Oryctolagus spp.). e208 Chinchilla epithelium  Chinchilla laniger.  e209 Gerbil epithelium  Meriones unguiculatus.  e210 Fox epithelium  Vulpes vulpes.  e211 Rabbit, urine proteins  Oryctolagus cuniculus (Oryctolagus spp.). e212 Swine, urine proteins  Sus scrofa (Sus scrofa domesticus; Sus spp.). e213 Parrot feathers  Ara spp. e214 Finch feathers  Lonchura domestica.  e215 Pigeon feathers  Streptopelia roseogrisea (Streptopelia spp.),Columbia spp. e216 Deer epithelium  Dama dama.  e217 Ferret epithelium  Mustela putorius.  e218 Chicken droppings  Gallus domesticus (Gallus gallus domesticus; Gallus spp.). e219 Chicken, serum proteins  Gallus domesticus (Gallus gallus domesticus; Gallus spp.). e220 Fel d 2, Cat serum albumin  Felis domesticus.  e221 Can f 3  Canis familiaris (Canis domesticus ) (Dog serum albumin ). e222 Swine serum albumin (Sus s PSA)  Sus scrofa (Sus scrofa domesticus; Sus spp.). e225 Lovebird feathers  Psittacoidea agapomis.  e226 Can f 5.0101  Canis familiaris.  e227 Equ c 1.0101  Equus caballus.  e228 Fel d 4.0101  Felis domesticus.  e230 Equ c 3  Equus caballus.  e231 Mus m 1  Mus musculus.   Food  f9 Rice  Oryza sativa.  f12 Pea (green pea)  Pisum sativum.  f15 White bean  Phaseolus vulgaris.  f19 Cayenne pepper  Capsicum frutescens (Capsicum annum ). f21 Sugar cane  Saccharum officinarum.  f22 Raspberry  Rubus idaeus.  f26 Pork  Sus scrofa (Sus scrofa domesticus; Sus spp.). f29 Watermelon  Citrullus lanatus (Citrullus vulgaris ). f31 Carrot  Daucus carota.  f32 Oyster mushroom  Pleurotus ostreatus.  f33 Orange  Citrus sinensis.  f35 Potato  Solanum tuberosum.  f43 Mother's milk  Homo sapiens.  f44 Strawberry  Fragaria vesca (Fragaria spp.). f45 Yeast, baker's  Saccharomyces cerevisiae.  f46 Pepper, Red  Capsicum annuum.  f47 Garlic  Allium sativum.  f48 Onion  Allium cepa.  f49 Apple  Malus x domestica (Malus spp.). f51 Bamboo shoot  Phyllostachys pubescens.  f52 Cacao/chocolate  Theobroma cacao.  f54 Sweet potato  Ipomoea batatas.  f55 Common millet  Panicum miliaceum.  f56 Foxtail millet  Setaria italica.  f57 Japanese millet  Echinochloa crus-galli.  f58 Pacific squid  Todarodes pacificus.  f59 Octopus  Octopus vulgaris (Octopus spp.). f63 Kefir NA.  f67 Parmesan cheese NA.  f81 Cheese, cheddar type NA.  f82 Cheese, mold type NA.  f83 Chicken  Gallus domesticus (Gallus gallus domesticus; Gallus spp.). f86 Parsley  Petroselinum crispum.  f87 Melon  Cucumis melo Cucumis melo + Citrullus lanatus.  f88 Mutton (lamb)  Ovis aries (Ovis spp.). f90 Malt  Hordeum vulgare.  f92 Banana  Musa spp. f93 Cacao  Theobroma cacao.  f94 Pear  Pyrus communis (Pyrus spp.). f97 Yam  Dioscorea spp.Dioscorea opposita.  f97 Chamomile tea  Matricaria chamomilla.  f98 Gliadin  Triticum aestivum (Triticum spp.). f102 Cantaloupe  Cucumis melo var. cantalupensis.  f105 Chocolate  Theobroma cacao.  f109 Cottonseed  Gossypium hirsutum.  f110 Giant radish  Raphanus sativus.  f118 Zucchini  Cucurbita pepo.  f119 Radish  Raphanus sativus.  f120 Venison  Capreolus capeolus.  f121 Pinto bean  Phaseolus vulgaris.  f122 Cheese, American NA.  f127 Black-eyed pea  Vigna unguiculata.  f131 Black Olive  Olea europaea.  f136 Red beet  Beta vulgaris var. conditiva.  f139 Goat's Cheese  Capra aegagrus.  f140 Bran NA.  f141 Corn (vegetables)  Zea mays.  f152 Green bell pepper  Capsicum annuum.  f155 Brewer's yeast  Saccharomyces carlsbergensis.  f157 Duck  Anas domesticus.  f158 Goose  Anser anser.  f160 Camembert cheese NA.  f162 Nectarine  Prunus persica var. nucipersica.  f163 Kohlrabi  Brassica oleracea var. gongylodes.  f65 Perch   f166 Leek  Allium porrum.  f170 Cheese (Switzerland) (Swiss cheese) NA.  f174 Fig  Ficus carica.  f177 Cranberry  Vaccinium macrocarpon.  f179 Raisin  Vitis spp. f182 Lima bean  Phaseolus lunatus.  f198 Flaxseed (bruised grain)  Linum usitatissimum.  f199 Untreated native milk  Bos domesticus (Bos taurus; Bos spp.). f208 Lemon  Citrus limon.  f209 Grapefruit  Citrus paradisi.  f210 Pineapple  Ananas comosus.  f211 Blackberry  Rubus fruticosus.  f212 Mushroom (champignon)  Agaricus hortensis (Agaricus spp.). f213 Rabbit  Oryctolagus cuniculus (Oryctolagus spp.). f214 Spinach  Spinacia oleracea.  f215 Lettuce  Lactuca sativa.  f216 Cabbage  Brassica oleracea var. capitata.  f217 Brussels sprouts  Brassica oleracea var. gem.  f218 Paprika, sweet pepper  Capsicum annuum.  f219 Fennel seed  Foeniculum vulgare.  f219 Sage  Salvia officinalis.  f220 Cinnamon  Cinnamomum spp. f221 Coffee  Coffea spp. f222 Tea  Camellia sinensis.  f223 Green olive  Olea europaea.  f225 Summer squash, pumpkin  Cucurbita pepo.  f225 Pumpkin  Cucurbita maxima.  f226 Pumpkin seed  Cucurbita pepo.  f227 Sugar-beet seed  Beta vulgaris.  f229 Safflower Seed  Carthamus tinctorius.  f231 Milk, boiled  Bos domesticus (Bos taurus; Bos spp.). f234 Vanilla  Vanilla planifolia.  f237 Apricot  Prunus armeniaca.  f241 Gouda cheese NA.  f242 Cherry  Prunus avium.  f244 Cucumber  Cucumis sativus.  f246 Guar, guar gum  Cyamopsis tetragonoloba.  f247 Honey NA.  f248 Rosemary  Rosmarinus officinalis.  f254 Plaice  Pleuronectes platessa.  f255 Plum  Prunus domestica ,Prunus americana.  f258 Squid  Loligo spp. f259 Grape  Vitis vinifera (Vitis spp.). f260 Broccoli  Brassica oleracea var. italica (Brassica oleracea var. cultivar ). f261 Asparagus  Asparagus officinalis.  f262 Aubergine, eggplant  Solanum melongena.  f263 Green pepper  Piper nigrum ,Capsicum annuum.  f264 Eel  Anguilla anguilla.  f265 Caraway  Carum carvi.  f265 Cumin  Cuminum cyminum.  f266 Mace  Myristica fragrans.  f267 Cardamon  Elettaria cardamomum.  f268 Clove  Syzygium aromaticum.  f269 Basil  Ocimum basilicum.  f270 Ginger  Zingiber officinale.  f271 Anise  Pimpinella anisum.  f272 Tarragon  Artemisia dracunculus.  f273 Thyme  Thymus vulgaris.  f274 Marjoram  Origanum majorana.  f275 Lovage  Levisticum officinale.  f276 Fennel, fresh  Foeniculum vulgare.  f277 Dill  Anethum graveolens.  f278 Bay leaf  Laurus nobilis.  f279 Chili pepper  Capsicum frutescens.  f280 Black pepper  Piper nigrum.  f281 Curry (Santa Maria) NA.  f282 Nutmeg  Myristica fragrans.  f283 Oregano  Origanum vulgare.  f284 Turkey meat  Meleagris gallopavo.  f285 Elk/moose meat  Alces spp. f286 Mare's milk  Equus caballus (Equus spp.). f287 Red kidney bean  Phaseolus vulgaris.  f288 Blueberry  Vaccinium myrtillus (Vaccinium spp.). f289 Date  Phoenix dactylifera.  f291 Cauliflower  Brassica oleracea var. botrytis.  f292 Guava  Psidium guajava.  f293 Papaya  Carica papaya.  f294 Passion fruit, Maracuja  Passiflora edulis (Passiflora spp.). f295 Carambola  Averrhoa carambola.  f296 Carob  Ceratonia siliqua.  f297 Gum Arabic  Acacia senegal (Acacia spp.). f298 Tragacanth  Astragalus spp. f299 Sweet chestnut (chestnut)  Castanea sativa.  f300 Pinto bean  Phaseolus spp. f301 Persimmon (kaki fruit, sharon)  Diospyros kaki.  f302 Mandarin (tangerine, clementine, satsumas)  Citrus reticulata.  f305 Fenugreek  Trigonella foenum-graecum.  f306 Lime  Citrus aurantifolia.  f307 Hake  Merluccius merluccius.  f308 Sardine (pilchard)  Sardina pilchardus.  f310 Blue vetch  Lathyrus sativus.  f311 Megrim  Lepidorhombus whiffiagonis.  f315 Green bean  Phaseolus vulgaris.  f316 Rape seed  Brassica napus.  f317 Coriander  Coriandrum sativum.  f318 Jack fruit  Artocarpus heterophyllus.  f319 Beetroot  Beta vulgaris.  f320 Crayfish  Astacus astacus.  f321 Horse meat  Equus caballus (Equus spp.). f322 Red currant  Ribes sylvestre.  f324 Hop (fruit cone)  Humulus lupulus.  f325 Saffron  Colchicum autumnale.  f328 Fig  Ficus carica.  f329 Watermelon  Citrullus lanatus.  f330 Rose hip  Rosa spp. f331 Saffron  Crocus sativus.  f332 Mint  Mentha piperita.  f333 Linseed  Linum usitatissimum.  f336 Jujube  Ziziphus jujuba.  f336 Wine vinegar  Vitis vinifera (Vitis spp.). f337 Sole  Solea solea.  f337 English sole  Parophrys vetulus.  f338 Wine, white  Vitis vinifera (Vitis spp.). f339 Allspice  Pimenta dioica.  f339 Wine, red  Vitis vinifera (Vitis spp.). f341 Cranberry  Vaccinium oxycoccus ,Vaccinium macrocarpon.  f342 Olive (black, fresh)  Olea europaea.  f343 Raspberry  Rubus idaeus.  f344 Sage  Salvia officinalis.  f346 Chives  Allium schoenoprasum.  f347 Quinoa  Chenopodium quinoa.  f348 Litchi  Litchi chinensis.  f349 Chum salmon roe  Oncorhynchus keta.  f358 Artichoke  Cynara scolymus.  f360 Yogurt NA.  f368 Black bass  Micropterus dolomieu (Micropterus dolomieui ). f374 Karaya gum  Sterculia urens.  f375 Horseradish  Armoracia rusticana.  f377 Maple syrup NA.  f379 Okra  Abelmoschus esculentus.  f382 Beet, sugar  Beta vulgaris var. altissima.  f401 Loquat  Eriobotrya japonica.  f402 Fig  Ficus carica.  f403 Brewer's yeast  Saccharomyces cerevisiae.  f405 Mint  Mentha spp. f406 Arugula  Eruca vesicaria.   House Dust  h1 Greer Labs., Inc NA.  h2 Hollister-Stier Labs NA.  h6 Japan NA.   Venoms & Insects  i7 Midge  Chironomus yoshimatsui.  i8 Moth  Bombyx mori ,Heterocera spp. i47 Water flea  Daphnia spp. i49 Deer fly  Chrysops spp. i51 Black ant  Camponotus pennsylvanicus.  i54 Flea mix (dog/cat), common flea  Ctenocephalides spp. i71 Mosquito  Aedes communis ,Aedes spp.and Culex spp. i72 Green nimitti  Cladotanytarsus lewisi.  i73 Blood worm  Chironomus thummi ,Chironomusri parius ,Chironomus spp. i75 European hornet  Vespa crabro.  i76 Berlin beetle  Trogoderma angustum.  i77 European paper wasp  Polistes dominulus.  i78 Fly  Musca domestica.  i80 Bumblebee  Bombus pennsylvanicus.  i201 Horse bot fly  Gasterophilus intestinalis.  i202 Grain weevil  Sitophilus granarius.  i203 Mediterranean flour moth  Ephestia kuehniella (Anagasta kuehniella ). i204 Horse fly  Tabanus spp. i205 Bumblebee  Bombus terrestris.  i208 Api m 1.0101  Apis mellifera.  a45 Api m 1  Apis mellifera.  i209 Ves v 5.0101  Vespula vulgaris.  a670 Ves v 5  Vespula vulgaris.  i210 Pol d 5.0101  Polistes dominulus.  i211 Ves v 1.0101  Vespula vulgaris.  i213 Api m 4  Apis mellifera.  i214 Api m 2  Apis mellifera.  i215 Api m 3  Apis mellifera.  i216 Api m 5  Apis mellifera.  i217 Api m 10  Apis mellifera.  i220 Bla g 1.0101  Blattella germanica.  i221 Bla g 2.0101  Blattella germanica.  i222 Bla g 5.0101  Blattella germanica.  i223 Bla g 7  Blattella germanica.  a46 Api m 2  Apis mellifera.   Miscellaneous  o1 Cotton, crude fibers  Gossypium spp. o3 Cotton (treated)  Gossypium spp. o70 Seminal fluid  Homo sapiens.  o71  Staphylococcus aureus  Staphylococcus aureus.  o72  Pichia pastoris crude extract customer specific Pichia pastoris.  o72 Sperm-sediment  Homo sapiens.  o73  Pichia pastoris crude extr. vector customer specific Pichia pastoris.  o74  Pichia pastoris with vector customer specific Pichia pastoris.  o201 Tobacco leaf, tobacco dust  Nicotiana tabacum.  o202 Artemia salina, fish feed  Artemia salina.  o203 Tetramin, fish feed NA.  o207 Daphnia, fish feed  Daphnia spp. o211 Mealworm  Tenebrio molitor.  o212 Streptavidin  Streptomyces avidini.  o213 MBP (maltose binding protein)  Escherichia coli.  o214 CCD; MUXF3 from bromelain  Ananas comosus.  o72 Enterotoxin A (Sta a SEA)  Staphylococcus aureus.  o73 Enterotoxin B (Sta a SEB)  Staphylococcus aureus.   Parasites  p1 Ascaris  Ascaris suum.  p2 Echinococcus  Echinococcus granulosus.  p3 Schistosoma  Schistosoma mansoni.  p4 Anisakis (Herring Worm)  Anisakis simplex (Anisakis spp.). p5 Toxocara canis  Toxocara canis.  p10 Ani s 3.0101  Anisakis simplex (Anisakis spp.). p11 Ani s 1  Anisakis simplex (Anisakis spp.).  Occupational  k4 Threshing dust NA.  k5 Flax NA.  k7 Hay Dust NA.  k8 Hop (hops)  Humulus lupulus.  k12 Grain mill dust NA.  k14 Kapok NA.  k20 Sheep's wool (treated) (wool)  Ovis aries (Ovis spp.). k21 Sheep's wool (Untreated)  Ovis aries (Ovis spp.). k23 Straw Dust NA.  k33 Oak NA.  k70 Green coffee bean  Coffea spp. k71 Castor bean  Ricinus communis.  k72 Ispaghula  Plantago psyllium/Plantago ovata.  k73 Silk waste NA.  k74 Silk  Bombyx mori.  k75 Isocyanate TDI (Toluene diisocyanate) NA.  k76 Isocyanate MDI (Diphenylmethane diisocyanate) NA.  k77 Isocyanate HDI (Hexamethylen diisocyanate) NA.  k78 Ethylene oxide NA.  k79 Phthalic anhydride NA.  k80 Formaldehyde/Formalin NA.  k81 Ficus  Ficus benjamina (Ficus spp.). k83 Cotton seed  Gossypium hirsutum.  k84 Sunflower seed  Helianthus annuus.  k85 Chloramin T NA.  k86 Trimellitic anhydride, TMA NA.  k87 Asp o 21, alpha-amylase  Aspergillus oryzae.  k89 Orris root  Iris florentina.  k99 HSA (Human Serum Albumin) (Hom s HSA)  Homo sapiens.  k201 Car p 1, Papain  Carica papaya.  k202 Ana c 2, Bromelain  Ananas comosus.  k204 Maxatase  Bacillus licheniformis.  k205 Alcalase  Bacillus spp. k206 Savinase, Protease 1 (Bac l Subtilisin)  Bacillus spp. k208 Gal d 4, Lysozyme  Gallus domesticus (Gallus gallus domesticus; Gallus spp.). k209 Hexahydrophtalic anhydrid NA.  k210 Maleic anhydride NA.  k211 Methyltetrahydrophtalic anhydrid NA.  k212 Abachi wood dust  Triplochiton scleroxylon.  k213 Pepsin (Sus s Pepsin)  Sus scrofa (Sus scrofa domesticus; Sus spp.). k213 TCPA NA.  k214 Bougainvillea  Bougainvillea spp. k225 Horse radish peroxidase (Arm r HRP)  Armoracia rusticana.  k226 Ascorbate oxidase (Cuc p ascorbate oxidase)  Cucurbita pepo.  k301 Flour dust  Triticum spp. k501 Savinase customer specific Proprietary knowledge of customer.  k502 Lipolase customer specific Proprietary knowledge of customer.  k503 Termamyl customer specific Proprietary knowledge of customer.  k504 Clazinase customer specific Proprietary knowledge of customer.

## Predicate Devices

- IMMULITE® 2000 3gAllergy™ Specific IgE assay ([K013134](/device/K013134.md), [K021206](/device/K021206.md), [K013135](/device/K013135.md), [K021208](/device/K021208.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}

1

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number:
k091984

B. Purpose for Submission:
Modification to device

C. Measurand:
Allergen Specific IgE (Black pepper, Broccoli, Cabbage, Cheese-Mold Type, Cherry, Chestnut, Chocolate, Coffee, Cucumber, Grape, Grapefruit, Haddock, Lamb, Lemon, Lima Bean, Peach, Pear, Pineapple, Plum, Pumpkin, Red Snapper, Sole, Spinach, Sweet Potato, Trout, Turkey meat, Watermelon)

D. Type of Test:
Quantitative, chemiluminiscent immunoassay

E. Applicant:
Siemens Healthcare Diagnostics, Inc.

F. Proprietary and Established Names:
IMMULITE® 2000 3gAllergy™ Specific IgE Assay kit

G. Regulatory Information:
1. Regulation section:
21 CFR § 866.5750, Radioallergosorbent (RAST) test systems
2. Classification:
Class II
3. Product code:
DHB System, Test, Radioallergosorbent (RAST), Immunological
4. Panel:
Immunology (82)

H. Intended Use:
1. Intended use:
For in vitro diagnostic use with the IMMULITE 2000 Analyzer – for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE-mediated allergic disorders.
2. Indication(s) for use:
Same as Intended use.
3. Special conditions for use statement(s):
For prescription only.
4. Special instrument requirements:
IMMULITE 2000 Analyzer (k970227)

I. Device Description:
Each device contains the following: 3gAllergy™ specific IgE bead pack (3 packs of 200 beads coated with anti-ligand); specific IgE reagent wedge: 30 mL alkaline phosphatase (bovine calf intestine) conjugated to monoclonal murine anti-human IgE antibody in a human/nonhuman serum buffer matrix (equally dispensed in 1 wedge with B & C chambers); specific IgE adjustors: low and high (2 vials, 2 mL each) of human IgE in a nonhuman serum matrix with preservative; specific IgE adjustor

{1}

antibody: 2 tubes,  $2.75\mathrm{mL}$  each) ready to use ligand-labeled polyclonal goat anti-human IgE antibody with preservative; specific IgE universal kit controls: (2 vials, 2 mL each) human IgE in a nonhuman sample matrix with preservative; specific IgE control antibody: (2 tubes,  $2.75\mathrm{mL}$  each) ready to use ligand-labeled polyclonal goat anti-human IgE antibody with preservative. Kit components supplied separately:  $3\mathrm{gAllergy}^{\mathrm{TM}}$  specific IgE sample diluent (concentrated ready to use 1 vial,  $25\mathrm{mL}$ ); chemiluminiscent substrate; probe wash; probe cleaning kit; disposable reaction tubes; bar coded allergen holder wedges serially coded 1-33; 34 -66; 67-99; allergen tube caps and tube septa.

# J. Substantial Equivalence Information:

1. Predicate device name(s): IMMULITE® 2000 3gAllergy™ Specific IgE
2. Predicate K number(s): k013134
3. Comparison with predicates:

|  Similarities  |   |   |
| --- | --- | --- |
|  Item | New Device | Predicate Device  |
|  Intended use | For in vitro diagnostic use with the IMMULITE 2000 Analyzer – for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE-mediated allergic disorders. | Same  |
|  Technology | Chemiluminescence | Same  |
|  Assay performance | Assay to be specific to allergen-specific IgE | Same  |
|  Calibrators | Low and high | Same  |
|  Controls | Specific IgE and Antibody and Specific IgE Universal Controls | Same  |
|  Sample type | Serum | Same  |
|  Result Interpretation | Quantitative values in kU/L; Interpretation of class results for two scoring systems: Standard and Extended standard | Same  |
|  Differences  |   |   |
| --- | --- | --- |
|  Item | New Device | Predicate Device  |
|  Total number of Allergens | Twenty seven | One hundred and ten  |
|  Types of Specific Allergens | 27 Specific Food Allergens | 110 Specific Allergens:8 Animal epithelia, 2 House dusts,39 Food, 13 Grasses, 5 Insects, 5Mites, 10 Molds, 1 Latex, 14Trees, 13 Weeds  |

{2}

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

Standard documents:

CLSI I/LA 20-A: Evaluation Methods and Analytical Performance Characteristics of Immunological Assays for Human Immunoglobulin E (IgE)

CLSI EP5-A2: Evaluation of Precision Performance of Quantitative Methods;

Approved Guideline - Second Edition

Guidance document:

FDA Guidance - Radioallergosorbent Test (RAST) Methods for Allergen-Specific Immunoglobulin E (IgE) 510(k); Final Guidance

# L. Test Principle:

The assay is a solid-phase, two-step, chemiluminiscent immunoassay that exploits liquid phase kinetics in a bead format. The allergens are covalently bound to a soluble polymer/co-polymer matrix, which is labeled with a ligand. The assay specific antibody is labeled with alkaline phosphatase. The use of an amino acid co-polymer amplifies the amount of allergen that the matrix can support. The chemiluminiscent detection system is a phosphatase ester of stabilized dioxatane. Cleavage of the phosphate ester by alkaline phosphatase results in the decomposition of dioxatane and the emission of photons, which are quantified by a luminometer.

# M. Performance Characteristics (if/when applicable):

# 1. Analytical performance:

# a. Precision/Reproducibility:

Reproducibility of the assay was assessed by testing three positive samples and one negative control sample of each allergen (Black pepper, Broccoli, Cabbage, Cheese-Mold Type, Cherry, Chestnut, Chocolate, Coffee, Cucumber, Grape, Grapefruit, Haddock, Lamb, Lemon, Lima Bean, Peach, Pear, Pineapple, Plum, Pumpkin, Red Snapper, Sole, Spinach, Sweet Potato, Trout, Turkey meat, Watermelon) in duplicate twice a day for 20 different days  $(n = 80)$ .

The sponsor's criterion for the negative sample was the average dose must be  $< 0.10\mathrm{kU / L}$ ; all negative sample results were within the acceptance criterion. The sponsor's acceptance criterion for the positive samples was  $\leq 15\%$  CV for both within-run and total precision. Three allergen lots were tested for each allergen; representative data from one lot is shown below for the positive samples. The intra-assay and inter-assay  $\% \mathrm{CV}$  ranges were from  $2.68\%$  to  $11.08\%$  and  $3.94\%$  to  $12.30\%$ , respectively (see tables below).

Allergen: Black Pepper

|  Sample | Mean (kU/L) | Intra-assay |   | Inter-assay  |   |
| --- | --- | --- | --- | --- | --- |
|   |   |  SD (kU/L) | %CV | SD (kU/L) | %CV  |
|  Positive #1 | 1.41 | 0.59 | 4.18 | 0.073 | 5.18  |
|  Positive #2 | 3.43 | 0.380 | 11.08 | 0.422 | 12.30  |
|  Positive #3 | 6.81 | 0.250 | 3.67 | 0.571 | 8.38  |

{3}

Allergen: Broccoli

|  Sample | Mean (kU/L) | Intra-assay |   | Inter-assay  |   |
| --- | --- | --- | --- | --- | --- |
|   |   |  SD (kU/L) | %CV | SD (kU/L) | %CV  |
|  Positive #1 | 12.02 | 0.546 | 4.54 | 0.759 | 6.31  |
|  Positive #2 | 5.68 | 0.251 | 4.42 | 0.338 | 5.95  |
|  Positive #3 | 2.37 | 0.091 | 3.84 | 0.127 | 5.36  |

Allergen: Cabbage

|  Sample | Mean (kU/L) | Intra-assay |   | Inter-assay  |   |
| --- | --- | --- | --- | --- | --- |
|   |   |  SD (kU/L) | %CV | SD (kU/L) | %CV  |
|  Positive #1 | 0.78 | 0.023 | 2.95 | 0.053 | 6.79  |
|  Positive #2 | 14.40 | 0.591 | 4.10 | 0.971 | 6.74  |
|  Positive #3 | 22.92 | 0.801 | 3.49 | 1.422 | 6.20  |

Allergen: Cheese-Mold Type

|  Sample | Mean (kU/L) | Intra-assay |   | Inter-assay  |   |
| --- | --- | --- | --- | --- | --- |
|   |   |  SD (kU/L) | %CV | SD (kU/L) | %CV  |
|  Positive #1 | 1.20 | 0.037 | 3.08 | 0.059 | 4.92  |
|  Positive #2 | 1.66 | 0.052 | 3.13 | 0.067 | 4.04  |
|  Positive #3 | 6.04 | 0.241 | 3.99 | 0.287 | 4.75  |

Allergen: Cherry

|  Sample | Mean (kU/L) | Intra-assay |   | Inter-assay  |   |
| --- | --- | --- | --- | --- | --- |
|   |   |  SD (kU/L) | %CV | SD (kU/L) | %CV  |
|  Positive #1 | 3.31 | 0.130 | 3.93 | 0.221 | 6.68  |
|  Positive #2 | 1.10 | 0.036 | 3.27 | 0.70 | 6.36  |
|  Positive #3 | 11.19 | 0.390 | 3.49 | 0.981 | 8.77  |

Allergen: Chestnut

|  Sample | Mean (kU/L) | Intra-assay |   | Inter-assay  |   |
| --- | --- | --- | --- | --- | --- |
|   |   |  SD (kU/L) | %CV | SD (kU/L) | %CV  |
|  Positive #1 | 7.93 | 0.238 | 3.00 | 0.396 | 4.99  |
|  Positive #2 | 2.86 | 0.108 | 3.78 | 0.135 | 4.72  |
|  Positive #3 | 5.81 | 0.181 | 3.12 | 0.261 | 4.49  |

Allergen: Chocolate

|  Sample | Mean (kU/L) | Intra-assay |   | Inter-assay  |   |
| --- | --- | --- | --- | --- | --- |
|   |   |  SD (kU/L) | %CV | SD (kU/L) | %CV  |
|  Positive #1 | 0.43 | 0.931 | 7.21 | 0.038 | 8.84  |
|  Positive #2 | 1.13 | 0.085 | 7.52 | 0.095 | 8.41  |
|  Positive #3 | 0.41 | 0.029 | 7.07 | 0.038 | 9.27  |

{4}

Allergen: Coffee

|  Sample | Mean (kU/L) | Intra-assay |   | Inter-assay  |   |
| --- | --- | --- | --- | --- | --- |
|   |   |  SD (kU/L) | %CV | SD (kU/L) | %CV  |
|  Positive #1 | 0.58 | 0.020 | 3.45 | 0.041 | 7.07  |
|  Positive #2 | 1.84 | 0.075 | 4.08 | 0.128 | 6.96  |
|  Positive #3 | 0.61 | 0.024 | 3.93 | 0.048 | 7.87  |

Allergen: Cucumber

|  Sample | Mean (kU/L) | Intra-assay |   | Inter-assay  |   |
| --- | --- | --- | --- | --- | --- |
|   |   |  SD (kU/L) | %CV | SD (kU/L) | %CV  |
|  Positive #1 | 2.85 | 0.097 | 3.40 | 0.167 | 5.86  |
|  Positive #2 | 2.10 | 0,082 | 3.90 | 0.168 | 8.00  |
|  Positive #3 | 8.38 | 0.256 | 3.05 | 0.621 | 7.41  |

Allergen: Grape

|  Sample | Mean (kU/L) | Intra-assay |   | Inter-assay  |   |
| --- | --- | --- | --- | --- | --- |
|   |   |  SD (kU/L) | %CV | SD (kU/L) | %CV  |
|  Positive #1 | 5.21 | 0.189 | 3.63 | 0.292 | 5.60  |
|  Positive #2 | 1.29 | 0.047 | 3.64 | 0.064 | 4.96  |
|  Positive #3 | 14.20 | 0.464 | 3.27 | 0.707 | 4.98  |

Allergen: Grapefruit

|  Sample | Mean (kU/L) | Intra-assay |   | Inter-assay  |   |
| --- | --- | --- | --- | --- | --- |
|   |   |  SD (kU/L) | %CV | SD (kU/L) | %CV  |
|  Positive #1 | 2.68 | 0.092 | 3.43 | 0.160 | 5.97  |
|  Positive #2 | 1.07 | 0.031 | 2.90 | 0.088 | 8.22  |
|  Positive #3 | 13.79 | 0.524 | 3.80 | 0.988 | 7.16  |

Allergen: Haddock

|  Sample | Mean (kU/L) | Intra-assay |   | Inter-assay  |   |
| --- | --- | --- | --- | --- | --- |
|   |   |  SD (kU/L) | %CV | SD (kU/L) | %CV  |
|  Positive #1 | 0.084 | 0.031 | 3.69 | 0.038 | 4.52  |
|  Positive #2 | 5.21 | 0.176 | 3.38 | 0.268 | 5.14  |
|  Positive #3 | 8.66 | 0,387 | 4.47 | 0.413 | 4.77  |

Allergen: Lamb

|  Sample | Mean (kU/L) | Intra-assay |   | Inter-assay  |   |
| --- | --- | --- | --- | --- | --- |
|   |   |  SD (kU/L) | %CV | SD (kU/L) | %CV  |
|  Positive #1 | 2.96 | 0.105 | 3.55 | 0.180 | 6.08  |
|  Positive #2 | 9.50 | 0.359 | 3.78 | 0.591 | 6.22  |
|  Positive #3 | 7.87 | 0.319 | 4.05 | 0.509 | 6.47  |

{5}

Allergen: Lemon

|  Sample | Mean (kU/L) | Intra-assay |   | Inter-assay  |   |
| --- | --- | --- | --- | --- | --- |
|   |   |  SD (kU/L) | %CV | SD (kU/L) | %CV  |
|  Positive #1 | 12.13 | 0.407 | 3.36 | 0.621 | 5.12  |
|  Positive #2 | 1.16 | 0.048 | 4.14 | 0.065 | 5.60  |
|  Positive #3 | 3.88 | 0.147 | 3.79 | 0.266 | 6.86  |

Allergen: Lima Bean

|  Sample | Mean (kU/L) | Intra-assay |   | Inter-assay  |   |
| --- | --- | --- | --- | --- | --- |
|   |   |  SD (kU/L) | %CV | SD (kU/L) | %CV  |
|  Positive #1 | 3.89 | 0.176 | 4.52 | 0.257 | 6.61  |
|  Positive #2 | 5.85 | 0.229 | 3.91 | 0.320 | 5.47  |
|  Positive #3 | 14.77 | 0.539 | 3.65 | 0.668 | 4.52  |

Allergen: Peach

|  Sample | Mean (kU/L) | Intra-assay |   | Inter-assay  |   |
| --- | --- | --- | --- | --- | --- |
|   |   |  SD (kU/L) | %CV | SD (kU/L) | %CV  |
|  Positive #1 | 3.80 | 0.159 | 4.18 | 0.197 | 5.18  |
|  Positive #2 | 3.87 | 0.176 | 4.55 | 0.212 | 5.48  |
|  Positive #3 | 11.15 | 0.442 | 3.96 | 0.666 | 5.97  |

Allergen: Pear

|  Sample | Mean (kU/L) | Intra-assay |   | Inter-assay  |   |
| --- | --- | --- | --- | --- | --- |
|   |   |  SD (kU/L) | %CV | SD (kU/L) | %CV  |
|  Positive #1 | 1.63 | 0.058 | 3.56 | 0.105 | 6.44  |
|  Positive #2 | 4.36 | 0,117 | 2.68 | 0.268 | 6.15  |
|  Positive #3 | 6.61 | 0.212 | 3.21 | 0.428 | 6.48  |

Allergen: Pineapple

|  Sample | Mean (kU/L) | Intra-assay |   | Inter-assay  |   |
| --- | --- | --- | --- | --- | --- |
|   |   |  SD (kU/L) | %CV | SD (kU/L) | %CV  |
|  Positive #1 | 2.21 | 0.098 | 4.43 | 0.168 | 7.60  |
|  Positive #2 | 1.50 | 0.049 | 3.27 | 0.107 | 7.13  |
|  Positive #3 | 0.83 | 0.024 | 2.89 | 0.081 | 9.76  |

Allergen: Plum

|  Sample | Mean (kU/L) | Intra-assay |   | Inter-assay  |   |
| --- | --- | --- | --- | --- | --- |
|   |   |  SD (kU/L) | %CV | SD (kU/L) | %CV  |
|  Positive #1 | 1.38 | 0.117 | 8.48 | 0.136 | 9.86  |
|  Positive #2 | 3.93 | 0.127 | 3.23 | 0.211 | 5.37  |
|  Positive #3 | 2.81 | 0.087 | 3.10 | 0.147 | 5.23  |

{6}

Allergen: Pumpkin

|  Sample | Mean (kU/L) | Intra-assay |   | Inter-assay  |   |
| --- | --- | --- | --- | --- | --- |
|   |   |  SD (kU/L) | %CV | SD (kU/L) | %CV  |
|  Positive #1 | 0.98 | 0.063 | 6.43 | 0.076 | 7.76  |
|  Positive #2 | 3.33 | 0.136 | 4.08 | 0.187 | 5.62  |
|  Positive #3 | 8.92 | 0.306 | 3.43 | 0.413 | 4.63  |

Allergen: Red Snapper

|  Sample | Mean (kU/L) | Intra-assay |   | Inter-assay  |   |
| --- | --- | --- | --- | --- | --- |
|   |   |  SD (kU/L) | %CV | SD (kU/L) | %CV  |
|  Positive #1 | 15.92 | 0.612 | 3.84 | 0.723 | 4.54  |
|  Positive #2 | 3.74 | 0.129 | 3.45 | 0.182 | 4.87  |
|  Positive #3 | 15.14 | 0.427 | 2.82 | 0.700 | 4.62  |

Allergen: Sole

|  Sample | Mean (kU/L) | Intra-assay |   | Inter-assay  |   |
| --- | --- | --- | --- | --- | --- |
|   |   |  SD (kU/L) | %CV | SD (kU/L) | %CV  |
|  Positive #1 | 1.50 | 0.51 | 3.40 | 0.077 | 5.13  |
|  Positive #2 | 4.75 | 0.219 | 4.61 | 0.276 | 5.81  |
|  Positive #3 | 18.62 | 0.577 | 3.10 | 0.734 | 3.94  |

Allergen: Spinach

|  Sample | Mean (kU/L) | Intra-assay |   | Inter-assay  |   |
| --- | --- | --- | --- | --- | --- |
|   |   |  SD (kU/L) | %CV | SD (kU/L) | %CV  |
|  Positive #1 | 0.91 | 0.027 | 2.97 | 0.039 | 4.29  |
|  Positive #2 | 1.73 | 0.054 | 3.12 | 0.085 | 4.91  |
|  Positive #3 | 14.80 | 0.405 | 2.74 | 0.685 | 4.63  |

Allergen: Sweet Potato

|  Sample | Mean (kU/L) | Intra-assay |   | Inter-assay  |   |
| --- | --- | --- | --- | --- | --- |
|   |   |  SD (kU/L) | %CV | SD (kU/L) | %CV  |
|  Positive #1 | 6.71 | 0.238 | 4.22 | 0.352 | 5.25  |
|  Positive #2 | 4.09 | 0.178 | 4.35 | 0.273 | 6.67  |
|  Positive #3 | 1.97 | 0.081 | 4.11 | 0.102 | 5.18  |

Allergen: Trout

|  Sample | Mean (kU/L) | Intra-assay |   | Inter-assay  |   |
| --- | --- | --- | --- | --- | --- |
|   |   |  SD (kU/L) | %CV | SD (kU/L) | %CV  |
|  Positive #1 | 30.71 | 0.945 | 3.08 | 1.825 | 5.94  |
|  Positive #2 | 1.72 | 0.058 | 3.37 | 0.097 | 5.64  |
|  Positive #3 | 17.28 | 0.646 | 3.74 | 0.926 | 5.36  |

{7}

Allergen: Turkey Meat

|  Sample | Mean (kU/L) | Intra-assay |   | Inter-assay  |   |
| --- | --- | --- | --- | --- | --- |
|   |   |  SD (kU/L) | %CV | SD (kU/L) | %CV  |
|  Positive #1 | 1.36 | 0.045 | 3.31 | 0.117 | 8.60  |
|  Positive #2 | 4.80 | 0.150 | 3.25 | 0.211 | 4.40  |
|  Positive #3 | 6.99 | 0.233 | 3.33 | 0.642 | 9.18  |

Allergen: Watermelon

|  Sample | Mean (kU/L) | Intra-assay |   | Inter-assay  |   |
| --- | --- | --- | --- | --- | --- |
|   |   |  SD (kU/L) | %CV | SD (kU/L) | %CV  |
|  Positive #1 | 1.62 | 0.064 | 3.95 | 0.122 | 7.53  |
|  Positive #2 | 5.03 | 0.172 | 3.42 | 0.345 | 6.86  |
|  Positive #3 | 19.25 | 0.561 | 2.91 | 1.250 | 6.49  |

# Lot to lot reproducibility:

The above results were reanalyzed for lot-to-lot reproducibility. Within run imprecision between lots ranged from  $3.04\%$  to  $12.02\%$  and total imprecision from  $3.95\%$  to  $16.55\%$ . All three lots were within the acceptable criterion of  $\leq 20\%$  variability.

# b. Linearity/assay reportable range:

Linearity studies: For each allergen, two samples were diluted in 2-fold serial dilutions to 5 levels. The undiluted (neat) and diluted samples were tested with the specific allergen to demonstrate linearity at concentrations within the assay limits. Regression statistics for each allergen comparing the observed results to expected results are presented below.

|  Allergen | Regression Equation | N | Slope | 95% CI | Intercept | 95% CI  |
| --- | --- | --- | --- | --- | --- | --- |
|  Black pepper | Y=0.9975X+0.0404 | 12 | 0.9975 | 0.9761-1.0188 | -0.0404 | -0.0165-0.0973  |
|  Broccoli | Y=1.0035X+0.2560 | 12 | 1.0035 | 0.9666-1.045 | 0.2560 | -0.0089-0.5209  |
|  Cabbage | Y=0.9976X+0.0231 | 12 | 0.9976 | 0.9883-1.0068 | 0.0231 | -0.0077-0.0540  |
|  Cheese-Mold Type | Y=0.9929X+0.0656 | 12 | 0.9929 | 0.9594-1.0264 | 0.0656 | -0.0110-0.1202  |
|  Cherry | Y=1.0165X+0.2024 | 12 | 1.0165 | 0.9719-1.0612 | 0.2024 | -0.1789-0.5838  |
|  Chestnut | Y=1.0074X+0.2158 | 12 | 1.0074 | 0.9748-1.0399 | 0.2158 | -0.0857-0.5173  |
|  Chocolate | Y=1.0047X-0.0163 | 9 | 1.0047 | 0.9833-1.0261 | -0.0163 | -0.0349-0.0022  |
|  Coffee | Y=0.9876X+0.0824 | 11 | 0.9876 | 0.9168-1.0584 | 0.0824 | -0.0008-0.1655  |
|  Cucumber | Y=1.0003X+0.1336 | 12 | 1.0003 | 0.9736-1.0249 | 0.1336 | -0.1292-0.3963  |
|  Grape | Y=1.0117X+0.1622 | 12 | 1.0117 | 0.9811-1.0423 | 0.1622 | -0.1933-0.5177  |
|  Grapefruit | Y=0.9967X+0.0264 | 12 | 0.9967 | 0.9816-1.0119 | 0.0264 | -0.0277-0.0804  |
|  Haddock | Y=1.0010X+0.0653 | 12 | 1.0010 | 0.9852-1.0169 | 0.0653 | -0.1583-0.2888  |
|  Lamb | Y=1.0233X-0.2153 | 12 | 1.0233 | 0.9966-1.0499 | -0.2153 | -0.4527-0.0221  |
|  Lemon | Y=0.9995X+0.1424 | 12 | 0.9995 | 0.9836-1.0153 | 0.01424 | 0.0300-0.2549  |
|  Lima Bean | Y=0.9973X+0.0791 | 12 | 0.9973 | 0.9778-1.0167 | 0.0791 | 0.0067-0.1514  |
|  Peach | Y=0.9916X+0.1351 | 12 | 0.9916 | 0.9647-1.0185 | 0.1351 | -0.2444-0.5145  |
|  Pear | Y=1.0073X+0.4035 | 12 | 1.0073 | 0.9667-1.0480 | 0.4035 | -0.1411-0.9481  |
|  Pineapple | Y=0.9871X+0.0561 | 12 | 0.9871 | 0.9782-0.9960 | 0.0561 | 0.0373-0.0749  |
|  Plum | Y=1.0175X+0.0408 | 12 | 1.0175 | 0.9819-1.0531 | 0.0408 | -0.2704-0.3521  |
|  Pumpkin | Y=1.0033X+0.0589 | 12 | 1.0033 | 0.9805-1.0262 | 0.0589 | -0.0278-0.1455  |

{8}

|  Allergen | Regression Equation | N | Slope | 95% CI | Intercept | 95% CI  |
| --- | --- | --- | --- | --- | --- | --- |
|  Red Snapper | Y= 0.9914X + 0.0753 | 12 | 0.9914 | 0.9822–1.0006 | 0.0753 | 0.0421-0.1085  |
|  Sole | Y= 0.9966X + 0.0610 | 12 | 0.9966 | 0.9825–1.0106 | 0.0610 | -0.0042-0.1262  |
|  Spinach | Y= 1.0046X + 0.1871 | 12 | 1.0046 | 0.9568–1.0523 | 0.1871 | -0.0821-0.4563  |
|  Sweet Potato | Y= 0.9999X +0.1379 | 11 | 0.9999 | 0.9529–1.0469 | 0.1379 | 0.0074-0.2683  |
|  Trout | Y= 1.0038X – 0.0478 | 12 | 1.0038 | 0.9896–1.0181 | -0.0478 | -0.2083-0.1127  |
|  Turkey meat | Y= 1.0129X + 0.1070 | 12 | 1.0129 | 0.9823–1.0436 | 0.1070 | -0.0919-0.3058  |
|  Watermelon | Y= 1.0138X + 0.0405 | 12 | 1.0138 | 0.9856–1.0420 | 0.0405 | -0.2677-0.3486  |

Assay working ranges:  $0.1 - 100\mathrm{kU / L}$

c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability: The calibrators and controls are traceable to the WHO  $2^{\text{nd}}$  IRP 75/502 reference standard for human IgE.

Stability: Accelerated allergen stability testing (15-25°C for 57 days; assay kits stored at recommended temperature 2-8°C). The accelerated study supports a two year shelf-life stability claim.

d. Detection limit:

Limit of Blank (LoB): Three runs assaying the blank sample (zero calibrator) were performed to estimate the Limit of Blank (LoB). A total of three instruments were used per run. The maximum dose of the LoB was selected as the most conservative LoB:  $\mathrm{LoB}_{\mathrm{MAX}} = 0.026$ . The claimed LoB is  $0.1\mathrm{kU / L}$ .

Limit of Detection (LoD): Five samples were used to estimate the Limit of Detection (LoD). Sixty replicates of each sample were assayed per run. A total of 2 runs were completed with testing performed on 2 different instruments. The LoD was calculated for each sample using the formula:  $\mathrm{LoD} = \mathrm{LoB}_{\mathrm{MAX}} + (1.65 * \mathrm{SD}_{\mathrm{LOD}})$ . The claimed LoD is  $0.1 \mathrm{kU} / \mathrm{L}$

e. Analytical specificity:

Inhibition studies: Specificity of each allergen was verified through competitive inhibition testing using a single serum sample or a serum pool. A negative sample was used to measure the background response.

To initiate the inhibition experiment,  $70~\mu \mathrm{L}$  of undiluted and 4 levels of 5-fold serially diluted inhibitor extract were mixed with  $250~\mu \mathrm{L}$  of sample or pool. This mixture was incubated at room temperature  $(15 - 28^{\circ}\mathrm{C})$  for 1 hour allowing the immunological reaction to occur. Each sample mixture containing the inhibitor extract and the appropriate controls was assayed with one lot of each allergen. The percent  $(\%)$  inhibition was calculated according to the following formula:

(Response of pos. control (pos. sample - neg. sample) - sample response with inhibitor extract) (Response of pos. control (pos. sample - neg. sample))

X 100

The inhibition study demonstrated that the allergens tested are inhibited by the

{9}

relevant inhibitor extract in a concentration dependent fashion. Summary inhibition table is presented below.

|  Black pepper |   |  | Broccoli |   |  | Cabbage  |   |
| --- | --- | --- | --- | --- | --- | --- | --- |
|  Inhibitor Concentration (mg/mL) | % Inhibition |  | Inhibitor Concentration (mg/mL) | % Inhibition |  | Inhibitor Concentration (mg/mL) | % Inhibition  |
|  5 | 93.01 |  | 5 | 95.21 |  | 5 | 96.75  |
|  1 | 77.62 |  | 1 | 91.51 |  | 1 | 95.56  |
|  0.2 | 56.99 |  | 0.2 | 85.56 |  | 0.2 | 91.34  |
|  0.04 | 22.38 |  | 0.04 | 74.17 |  | 0.04 | 70.45  |
|  0.008 | 1.40 |  | 0.008 | 24.75 |  | 0.008 | 16.30  |
|  Cheese-Mold Type |   |  | Cherry |   |  | Chestnut  |   |
| --- | --- | --- | --- | --- | --- | --- | --- |
|  Inhibitor Concentration (mg/mL) | % Inhibition |  | Inhibitor Concentration (mg/mL) | % Inhibition |  | Inhibitor Concentration (mg/mL) | % Inhibition  |
|  5 | 89.34 |  | 5 | 98.94 |  | 5 | 95.98  |
|  1 | 88.83 |  | 1 | 92.40 |  | 1 | 90.12  |
|  0.2 | 80.71 |  | 0.2 | 76.56 |  | 0.2 | 49.64  |
|  0.04 | 74.11 |  | 0.04 | 57.76 |  | 0.04 | 0.00  |
|  0.008 | 16.75 |  | 0.008 | 46.57 |  | 0.008 | 2.70  |
|  Chocolate |   |  | Coffee |   |  | Cucumber  |   |
| --- | --- | --- | --- | --- | --- | --- | --- |
|  Inhibitor Concentration (mg/mL) | % Inhibition |  | Inhibitor Concentration (mg/mL) | % Inhibition |  | Inhibitor Concentration (mg/mL) | % Inhibition  |
|  5 | 79.53 |  | 5 | 74.53 |  | 5 | 97.89  |
|  1 | 82.46 |  | 1 | 66.98 |  | 1 | 96.22  |
|  0.2 | 50.29 |  | 0.2 | 39.62 |  | 0.2 | 91.22  |
|  0.04 | 27.49 |  | 0.04 | 13.21 |  | 0.04 | 84.76  |
|  0.008 | 5.26 |  | 0.008 | 10.85 |  | 0.008 | 35.31  |
|   |  |  |  |  |  | 0.0016 | 9.35  |
|  Grape, |   |  | Grapefruit |   |  | Haddock  |   |
| --- | --- | --- | --- | --- | --- | --- | --- |
|  Inhibitor Concentration (mg/mL) | % Inhibition |  | Inhibitor Concentration (mg/mL) | % Inhibition |  | Inhibitor Concentration (mg/mL) | % Inhibition  |
|  5 | 85.56 |  | 5 | 97.78 |  | 0.2 | 97.33  |
|  1 | 52.22 |  | 1 | 93.13 |  | 0.04 | 90.80  |
|  0.2 | 23.33 |  | 0.2 | 82.32 |  | 0.008 | 83.47  |
|  0.04 | 26.67 |  | 0.04 | 15.76 |  | 0.0016 | 80.20  |
|  0.008 | 14.44 |  | 0.008 | 0.81 |  | 0.0032 | 70.73  |
|   |  |  |  |  |  | 0.000064 | 18.47  |

{10}

|  Lamb |   |  | Lemon |   |  | Lima Bean  |   |
| --- | --- | --- | --- | --- | --- | --- | --- |
|  Inhibitor Concentration (mg/mL) | % Inhibition |  | Inhibitor Concentration (mg/mL) | % Inhibition |  | Inhibitor Concentration (mg/mL) | % Inhibition  |
|  5 | 95.86 |  | 5 | 91.50 |  | 5 | 96.94  |
|  1 | 92.88 |  | 1 | 86.82 |  | 1 | 91.68  |
|  0.2 | 84.86 |  | 0.2 | 83.36 |  | 0.2 | 82.49  |
|  0.04 | 62.10 |  | 0.04 | 59.91 |  | 0.04 | 54.49  |
|  0.008 | 34.02 |  | 0.008 | 7.57 |  | 0.008 | 21.66  |
|  Peach |   |  | Pear |   |  | Pineapple  |   |
| --- | --- | --- | --- | --- | --- | --- | --- |
|  Inhibitor Concentration (mg/mL) | % Inhibition |  | Inhibitor Concentration (mg/mL) | % Inhibition |  | Inhibitor Concentration (mg/mL) | % Inhibition  |
|  5 | 97.28 |  | 5 | 85.31 |  | 5 | 88.36  |
|  1 | 92.41 |  | 1 | 71.19 |  | 1 | 83.60  |
|  0.2 | 83.46 |  | 0.2 | 57.06 |  | 0.2 | 72.49  |
|  0.04 | 74.25 |  | 0.04 | 49.72 |  | 0.04 | 42.86  |
|  0.008 | 45.01 |  | 0.008 | 27.68 |  | 0.008 | 20.11  |
|  Plum |   |  | Pumpkin |   |  | Red Snapper  |   |
| --- | --- | --- | --- | --- | --- | --- | --- |
|  Inhibitor Concentration (mg/mL) | % Inhibition |  | Inhibitor Concentration (mg/mL) | % Inhibition |  | Inhibitor Concentration (mg/mL) | % Inhibition  |
|  5 | 97.86 |  | 5 | 93.18 |  | 0.2 | 83.58  |
|  1 | 82.91 |  | 1 | 83.36 |  | 0.04 | 74.68  |
|  0.2 | 67.67 |  | 0.2 | 57.98 |  | 0.008 | 76.29  |
|  0.04 | 46.50 |  | 0.04 | 33.97 |  | 0.0016 | 76.50  |
|  0.008 | 16.70 |  | 0.008 | 14.19 |  | 0.0032 | 46.46  |
|   |  |  |  |  |  | 0.000064 | 5.79  |
|  Sole |   |  | Spinach |   |  | Sweet Potato  |   |
| --- | --- | --- | --- | --- | --- | --- | --- |
|  Inhibitor Concentration (mg/mL) | % Inhibition |  | Inhibitor Concentration (mg/mL) | % Inhibition |  | Inhibitor Concentration (mg/mL) | % Inhibition  |
|  1 | 97.04 |  | 5 | 80.10 |  | 5 | 60.57  |
|  0.2 | 90.31 |  | 1 | 81.20 |  | 1 | 42.86  |
|  0.04 | 77.55 |  | 0.2 | 62.02 |  | 0.2 | 0.00  |
|  0.008 | 63.52 |  | 0.04 | 36.58 |  | 0.04 | 0.00  |
|  0.0016 | 47.50 |  | 0.008 | 15.75 |  | 0.008 | 3.43  |
|  0.0032 | 39.34 |  |  |  |  |  |   |

{11}

|  Trout |   |  | Turkey meat |   |  | Watermelon  |   |
| --- | --- | --- | --- | --- | --- | --- | --- |
|  Inhibitor Concentration (mg/mL) | % Inhibition |  | Inhibitor Concentration (mg/mL) | % Inhibition |  | Inhibitor Concentration (mg/mL) | % Inhibition  |
|  5 | 99.03 |  | 5 | 96.52 |  | 5 | 100.00  |
|  1 | 97.71 |  | 1 | 93.99 |  | 1 | 93.53  |
|  0.2 | 96.10 |  | 0.2 | 90.51 |  | 0.2 | 87.30  |
|  0.04 | 91.36 |  | 0.04 | 68.20 |  | 0.04 | 83.37  |
|  0.008 | 83.99 |  | 0.008 | 20.09 |  | 0.008 | 62.59  |
|  0.0016 | 78.25 |  |  |  |  |  | 12.70  |
|  0.0032 | 60.21 |  |  |  |  |  | 5.08  |
|  0.000064 | 12.99 |  |  |  |  |  |   |

Cross-reactivity: The manufacturer states there is no detectable crossreactivity with human serum immunoglobulins IgG, IgA, IgM or IgD at normal physiological levels.

f. Assay cut-off: Not applicable

2. Comparison studies:

a. Method comparison with predicate device: Refer to Clinical studies
b. Matrix comparison: Not applicable. Serum is the only matrix.

3. Clinical studies:

a. Clinical Sensitivity and specificity

Clinical performance of the IMMULITE® 2000 3gAllergy Specific IgE assay for Black pepper, Broccoli, Cabbage, Cheese-Mold Type, Cherry, Chestnut, Chocolate, Coffee, Cucumber, Grape, Grapefruit, Haddock, Lamb, Lemon, Lima Bean, Peach, Pear, Pineapple, Plum, Pumpkin, Red Snapper, Sole, Spinach, Sweet Potato, Trout, Turkey meat, Watermelon allergens was demonstrated by testing samples from non-atopic and atopic individuals. Atopic patients were selected from patients who had documented history of allergies to mold and/or pollen and/or skin prick tested. Information on the skin test allergen extracts (crude or purified) was not documented. Non-atopic patients were clinically known non-allergenic or total IgE < 130 ng/mL or 54 IU/mL (2.4 ng = 1 IU). Testing was performed on 156 samples for Black pepper, 156 samples for Broccoli, 155 samples for Cabbage, 158 samples for Cheese-Mold Type, 155 samples for Cherry, 153 samples for Chestnut, 190 samples for Chocolate, 130 samples for Coffee, 156 samples for Cucumber, 161 samples for Grape, 151 samples for Grapefruit, 139 samples for Haddock, 154 samples for Lamb, 161 samples for Lemon, 158 samples for Lima Bean, 156 samples for Peach, 152 samples for Pear, 152 samples for Pineapple, 152 samples for Plum, 151 samples for Pumpkin, 131 samples for Red Snapper, 136 samples for Sole, 149 samples for Spinach, 157 samples for Sweet Potato, 158 samples for Trout, 145 samples for Turkey meat, 156 samples for Watermelon.

{12}

Literature support was provided on allergens with low prevalence and % sensitivity as shown below:

|  Specific Allergen/ % Clinical Sen. | Literature(s) | Prevalence | Literature(s) | %Clinical Sensitivity Ranges  |
| --- | --- | --- | --- | --- |
|  F82: Cheese-Mold Type / 45% | Pereira B, Venter C, Grundy J, Clayton CB, Arshad SH, Dean T. J Allergy Clin Immunol. 2005 Oct;116(4):884-92 | 24-28% milk and dairy (young adults) | 1. Eriksson NE. Allergy. 1978 Aug;33(4):189-96.
2. Pereira B, Venter C, Grundy J, Clayton CB, Arshad SH, Dean T. J Allergy Clin Immunol. 2005 Oct;116(4):884-92 | 3%
8%  |
|  F105: Chocolate / 46% | 1. Osterballe M, Hansen TK, Mortz CG, Høst A, Bindslev-Jensen C. Pediatr Allergy Immunol. 2005 Nov;16(7):567-73.
2. Pereira B, Venter C, Grundy J, Clayton CB, Arshad SH, Dean T. J Allergy Clin Immunol. 2005 Oct;116(4):884-92 | 7-12%
23% | Eriksson NE. Allergy. 1978 Aug;33(4):189-96. | 2.3%  |
|  F42: Haddock / 32% | 1. O'Neil C, Helbling AA, Lehrer SB. Clin Rev Allergy. 1993 Summer;11(2):183-200.
2. Pereira B, Venter C, Grundy J, Clayton CB, Arshad SH, Dean T. J Allergy Clin Immunol. 2005 Oct;116(4):884-92 | 6.9-10.3% fish (in children)^{1}
8-15% fish (young adults)^{2} | O'Neil C, Helbling AA, Lehrer SB. Clin Rev Allergy. 1993 Summer;11(2):183-200. | 5-49%  |
|  F337: Sole / 37% | 1. O'Neil C, Helbling AA, Lehrer SB. Clin Rev Allergy. 1993 Summer;11(2):183-200.
2. Pereira B, Venter C, Grundy J, Clayton CB, Arshad SH, Dean T. J Allergy Clin Immunol. 2005 Oct;116(4):884-92 | 6.9-10.3% fish (in children)^{1}
8-15% fish (young adults)^{2} | O'Neil C, Helbling AA, Lehrer SB. Clin Rev Allergy. 1993 Summer;11(2):183-200. | 3-44%  |
|  F284: Turkey Meat / 48% | Zacharisen MC. WMJ. 2006 Jul;105(5):50-2. | 17% (chicken meat) | Zacharisen MC. WMJ. 2006 Jul;105(5):50-2. | 40% (chicken/turkey meat)  |

Sensitivity and specificity of the new device, based on diagnosis of atopic status, are shown in the tables below:

{13}

|  Allergen: Black pepper | Clinical Diagnosis  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Atopic | Non-atopic | Total  |
|  IMMULITE 2000 | positive | 27 | 0 | 27  |
|   |  negative | 24 | 105 | 129  |
|   |  Total | 51 | 105 | 156  |

Sensitivity:  $53\%$  (27/51)  $(95\% CI: 39 - 67\%)$
Specificity:  $100\%$  (105/105)

|  Allergen: Broccoli | Clinical Diagnosis  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Atopic | Non-atopic | Total  |
|  IMMULITE 2000 | positive | 35 | 1 | 36  |
|   |  negative | 16 | 104 | 120  |
|   |  Total | 51 | 105 | 156  |

Sensitivity:  $69\%$  (35/51)  $(95\% CI: 56 - 81\%)$
Specificity:  $99\%$  (104/105)  $(95\% CI: 97 - 101\%)$

|  Allergen: Cabbage | Clinical Diagnosis  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Atopic | Non-atopic | Total  |
|  IMMULITE 2000 | positive | 35 | 1 | 36  |
|   |  negative | 15 | 104 | 119  |
|   |  Total | 50 | 105 | 155  |

Sensitivity:  $70\%$  (35/50)  $(95\% CI: 57 - 83\%)$
Specificity:  $99\%$  (104/105)  $(95\% CI: 97 - 101\%)$

|  Allergen: Cheese-Mold Type | Clinical Diagnosis  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Atopic | Non-atopic | Total  |
|  IMMULITE 2000 | positive | 24 | 0 | 24  |
|   |  negative | 29 | 105 | 134  |
|   |  Total | 53 | 105 | 158  |

Sensitivity:  $45\%$  (24/53)  $(95\% CI: 32 - 59\%)$
Specificity:  $100\%$  (105/105)

|  Allergen: Cherry | Clinical Diagnosis  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Atopic | Non-atopic | Total  |
|  IMMULITE 2000 | positive | 36 | 1 | 37  |
|   |  negative | 14 | 104 | 118  |
|   |  Total | 50 | 105 | 155  |

Sensitivity:  $72\%$  (36/50)  $(95\% CI: 60 - 84\%)$
Specificity:  $99\%$  (104/105)  $(95\% CI: 97 - 101\%)$

|  Allergen: Chestnut | Clinical Diagnosis  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Atopic | Non-atopic | Total  |
|  IMMULITE 2000 | positive | 47 | 1 | 48  |
|   |  negative | 1 | 104 | 105  |
|   |  Total | 48 | 105 | 153  |

{14}

Sensitivity:  $98\%$  (47/48)  $(95\% CI: 94 - 102\%)$

Specificity:  $99\%$  (104/105)  $(95\% CI: 97 - 101\%)$

|  Allergen: Chocolate | Clinical Diagnosis  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Atopic | Non-atopic | Total  |
|  IMMULITE 2000 | positive | 17 | 0 | 17  |
|   |  negative | 20 | 153 | 173  |
|   |  Total | 37 | 153 | 190  |

Sensitivity:  $46\%$  (17/37)  $(95\% CI: 30 - 62\%)$

Specificity:  $100\%$  (153/153)

|  Allergen: Coffee, | Clinical Diagnosis  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Atopic | Non-atopic | Total  |
|  IMMULITE 2000 | positive | 19 | 6 | 25  |
|   |  negative | 9 | 96 | 105  |
|   |  Total | 28 | 102 | 130  |

Sensitivity:  $68\%$  (19/28)  $(95\% CI: 51 - 85\%)$

Specificity:  $94\%$  (96/102)  $(95\% CI: 90 - 99\%)$

|  Allergen: Cucumber | Clinical Diagnosis  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Atopic | Non-atopic | Total  |
|  IMMULITE 2000 | positive | 35 | 1 | 36  |
|   |  negative | 16 | 104 | 120  |
|   |  Total | 51 | 105 | 156  |

Sensitivity:  $69\%$  (35/51)  $(95\% CI: 56 - 81\%)$

Specificity:  $99\%$  (104/105)  $(95\% CI: 97 - 101\%)$

|  Allergen: Grape | Clinical Diagnosis  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Atopic | Non-atopic | Total  |
|  IMMULITE 2000 | positive | 42 | 1 | 43  |
|   |  negative | 14 | 104 | 118  |
|   |  Total | 56 | 105 | 161  |

Sensitivity:  $75\%$  (42/56)  $(95\% CI: 64 - 86\%)$

Specificity:  $99\%$  (104/105)  $(95\% CI: 97 - 101\%)$

|  Allergen: Grapefruit | Clinical Diagnosis  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Atopic | Non-atopic | Total  |
|  IMMULITE 2000 | positive | 33 | 2 | 35  |
|   |  negative | 13 | 103 | 116  |
|   |  Total | 46 | 105 | 151  |

Sensitivity:  $72\%$  (33/46)  $(95\% CI: 59 - 85\%)$

Specificity:  $98\%$  (103/105)  $(95\% CI: 95 - 101\%)$

{15}

|  Allergen: Haddock | Clinical Diagnosis  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Atopic | Non-atopic | Total  |
|  IMMULITE 2000 | positive | 12 | 1 | 13  |
|   |  negative | 25 | 101 | 126  |
|   |  Total | 37 | 102 | 139  |

Sensitivity:  $32\%$  (12/37)  $(95\% CI: 17 - 48\%)$
Specificity:  $99\%$  (101/102)  $(95\% CI: 97 - 101\%)$

|  Allergen: Lamb | Clinical Diagnosis  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Atopic | Non-atopic | Total  |
|  IMMULITE 2000 | positive | 33 | 0 | 33  |
|   |  negative | 16 | 105 | 121  |
|   |  Total | 49 | 105 | 154  |

Sensitivity:  $67\%$  (33/49)  $(95\% CI: 54 - 80\%)$
Specificity:  $100\%$  (105/105)

|  Allergen: Lemon | Clinical Diagnosis  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Atopic | Non-atopic | Total  |
|  IMMULITE 2000 | positive | 39 | 1 | 40  |
|   |  negative | 17 | 104 | 121  |
|   |  Total | 56 | 105 | 161  |

Sensitivity:  $70\%$  (39/56)  $(95\% CI: 58 - 82\%)$
Specificity:  $99\%$  (104/105)  $(95\% CI: 97 - 101\%)$

|  Allergen: Lima Bean | Clinical Diagnosis  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Atopic | Non-atopic | Total  |
|  IMMULITE 2000 | positive | 24 | 9 | 33  |
|   |  negative | 18 | 107 | 128  |
|   |  Total | 42 | 116 | 158  |

Sensitivity:  $55\%$  (24/42)  $(95\% CI: 40 - 69\%)$
Specificity:  $92\%$  (107/116)  $(95\% CI: 87 - 97\%)$

|  Allergen: Peach | Clinical Diagnosis  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Atopic | Non-atopic | Total  |
|  IMMULITE 2000 | positive | 42 | 2 | 44  |
|   |  negative | 9 | 103 | 112  |
|   |  Total | 51 | 105 | 156  |

Sensitivity:  $82\%$  (42/51)  $(95\% CI: 72 - 93\%)$
Specificity:  $98\%$  (103/105)  $(95\% CI: 95 - 101\%)$

|  Allergen: Pear | Clinical Diagnosis  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Atopic | Non-atopic | Total  |
|  IMMULITE 2000 | positive | 41 | 0 | 41  |
|   |  negative | 6 | 105 | 111  |
|   |  Total | 47 | 105 | 152  |

{16}

Sensitivity:  $87\%$  (41/47) (95% CI: 78-97%)

Specificity:  $100\%$  (105/105)

|  Allergen: Pineapple | Clinical Diagnosis  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Atopic | Non-atopic | Total  |
|  IMMULITE 2000 | positive | 30 | 0 | 30  |
|   |  negative | 17 | 105 | 122  |
|   |  Total | 47 | 105 | 152  |

Sensitivity:  $64\%$  (30/47) (95% CI: 50-78%)

Specificity:  $100\%$  (105/105)

|  Allergen: Plum | Clinical Diagnosis  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Atopic | Non-atopic | Total  |
|  IMMULITE 2000 | positive | 31 | 1 | 32  |
|   |  negative | 16 | 104 | 120  |
|   |  Total | 47 | 105 | 152  |

Sensitivity:  $66\%$  (31/47) (95% CI: 52-80%)
Specificity:  $99\%$  (104/105) (95% CI: 97-101%)

|  Allergen: Pumpkin | Clinical Diagnosis  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Atopic | Non-atopic | Total  |
|  IMMULITE 2000 | positive | 34 | 1 | 35  |
|   |  negative | 12 | 104 | 116  |
|   |  Total | 46 | 105 | 151  |

Sensitivity:  $74\%$  (34/46) (95% CI: 61-87%)
Specificity:  $99\%$  (104/105) (95% CI: 97-101%)

|  Allergen: Red Snapper | Clinical Diagnosis  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Atopic | Non-atopic | Total  |
|  IMMULITE 2000 | positive | 15 | 1 | 16  |
|   |  negative | 15 | 100 | 115  |
|   |  Total | 30 | 101 | 131  |

Sensitivity:  $50\%$  (15/30) (95% CI: 32-68%)
Specificity:  $99\%$  (100/101) (95% CI: 97-101%)

|  Allergen: Sole | Clinical Diagnosis  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Atopic | Non-atopic | Total  |
|  IMMULITE 2000 | positive | 13 | 1 | 14  |
|   |  negative | 22 | 100 | 122  |
|   |  Total | 35 | 101 | 136  |

Sensitivity:  $37\%$  (13/35) (95% CI: 21-53%)
Specificity:  $99\%$  (100/101) (95% CI: 97-100%)

{17}

18

|  Allergen: Spinach | Clinical Diagnosis  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Atopic | Non-atopic | Total  |
|  IMMULITE 2000 | positive | 35 | 1 | 36  |
|   |  negative | 9 | 104 | 113  |
|   |  Total | 44 | 105 | 149  |

Sensitivity: 80% (35/44) (95% CI: 68-91%)
Specificity: 99% (104/105) (95% CI: 97-101%)

|  Allergen: Sweet Potato | Clinical Diagnosis  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Atopic | Non-atopic | Total  |
|  IMMULITE 2000 | positive | 44 | 1 | 45  |
|   |  negative | 8 | 104 | 112  |
|   |  Total | 52 | 105 | 157  |

Sensitivity: 85% (44/52) (95% CI: 75-94%)
Specificity: 99% (104/105) (95% CI: 97-101%)

|  Allergen: Trout | Clinical Diagnosis  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Atopic | Non-atopic | Total  |
|  IMMULITE 2000 | positive | 31 | 0 | 31  |
|   |  negative | 22 | 105 | 127  |
|   |  Total | 53 | 105 | 158  |

Sensitivity: 58% (31/53) (95% CI: 45-72%)
Specificity: 100% (105/105)

|  Allergen: Turkey Meat | Clinical Diagnosis  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Atopic | Non-atopic | Total  |
|  IMMULITE 2000 | positive | 19 | 0 | 19  |
|   |  negative | 21 | 105 | 126  |
|   |  Total | 40 | 105 | 145  |

Sensitivity: 48% (19/40) (95% CI: 32-63%)
Specificity: 100% (105/105)

|  Allergen: Watermelon | Clinical Diagnosis  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Atopic | Non-atopic | Total  |
|  IMMULITE 2000 | positive | 30 | 6 | 36  |
|   |  negative | 16 | 104 | 120  |
|   |  Total | 46 | 110 | 156  |

Sensitivity: 65% (30/46) (95% CI: 51-79%)
Specificity: 95% (104/110) (95% CI: 90-99%)

b. Other clinical supportive data (when a. is not applicable):
Not applicable.

4. Clinical cut-off:
Not applicable.

5. Expected values/Reference range:

{18}

Not detected.

Refer to the Hoffman's 'Standard' and 'Extended Standard' classification system utilizing Class 0 to Class IV cut-offs (see Tables I and II below).

Table I: The Standard classification system utilizes the following class cutoffs:

|  Class | kU/L | Reactivity for Individual/Component Allergen(s)  |
| --- | --- | --- |
|  0* | < 0.10 | Absent or ND†  |
|   |  0.10 – 0.34 | Very Low  |
|  I | 0.35 – 0.69 | Low  |
|  II | 0.70 – 3.49 | Moderate  |
|  III | 3.50 – 17.49 | High  |
|  IV | 17.5 – 52.49 | Very High  |
|  V | 52.5 – 99.99  |   |
|  VI | ≥ 100  |   |

* Class 0 in the standard system signifies: not detectable by second-generation assays.
† ND: not detectable by IMMULITE 2000 3gAllergy.

Table II: The Extended standard classification system utilizes the following class cutoffs.

|  Class | kU/L | Reactivity for Individual/Component Allergen(s)  |
| --- | --- | --- |
|  0 | < 0.10 | Absent or ND†  |
|  0/1 | 0.10 – 0.24 | Very Low  |
|  I | 0.25 – 0.39 | Low  |
|  II | 0.40 – 1.29 | Moderate  |
|  III | 1.30 – 3.89 | High  |
|  IV | 3.90–14.99 | Very High  |
|  V | 15.00– 24.99  |   |
|  VI | ≥ 25  |   |

† ND: not detectable by IMMULITE 2000 3gAllergy

The choice of classification systems can be made by the user within the IMMULITE 2000 operational software.

Reference: Hoffman, DR. Comparison of methods of performing the Radioallergosorbent test:

Phadebas, Fadal-Nalebuff and Hoffman protocols. Ann Allergy. 1980 Dec; 45(6)

# N. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

# O. Conclusion:

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

---

**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHB/K091984](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHB/K091984)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com