← Product Code [DHB](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHB) · K150854

# ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f440, Hazelnut; ImmunoCAP Allergen f441, Walnut; ImmunoCAP Allergen f442, Walnut; ImmunoCAP Allergen f443, Cashew nut (K150854)

_Phadia AB · DHB · Dec 14, 2015 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHB/K150854

## Device Facts

- **Applicant:** Phadia AB
- **Product Code:** [DHB](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHB.md)
- **Decision Date:** Dec 14, 2015
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5750
- **Device Class:** Class 2
- **Review Panel:** Immunology

## Indications for Use

ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma (EDTA or Na-Heparin). ImmunoCAP Specific IgE is to be used with instruments Phadia 100, Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings, and is to be used in clinical laboratories.

## Device Story

ImmunoCAP system is a fully integrated, automated fluoroenzymeimmunoassay for quantitative determination of allergen-specific IgE in human serum or plasma. System utilizes purified native or recombinant allergens covalently coupled to a solid-phase support in a plastic housing. Patient sample is incubated with the allergen; specific IgE binds to the solid phase. After washing, enzyme-labeled anti-human IgE is added to form a complex. Following incubation and washing, a developing agent is added; fluorescence of the eluate is measured. Higher fluorescence indicates higher specific IgE concentration. Results are transformed to concentrations via a calibration curve. Used in clinical laboratories by trained personnel. Output assists clinicians in diagnosing IgE-mediated allergic disorders by identifying sensitization to specific allergen components (f439, f440, f441, f442, f443).

## Clinical Evidence

Clinical performance evaluated using 30+ clinical serum samples from patients with physician-diagnosed allergy and 100 non-atopic healthy donor samples. Sensitivity ranged from 83.3% to 96.9% across the five new allergen components; specificity was 100% for all. Analytical performance included precision (total CV% 2.85–9.93%), linearity (r²=1.00), and LoD (0.008–0.037 kU_A/L). Inhibition studies confirmed immunological specificity of the allergen components.

## Technological Characteristics

Fluoroenzymeimmunoassay; solid-phase allergen coupling. Reagents: purified native or recombinant allergens, β-Galactosidase-anti-human IgE conjugate. Instruments: Phadia 100, 250, 1000, 2500, 5000. Connectivity: Integrated data management software (IDM 5.67). Standards: CLSI EP5-A2, EP7-A2, EP17-A, EP25-A, I/LA20-A2, EN 13640. Sterilization: Not applicable (reagents).

## 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

- ImmunoCAP system, ImmunoCAP Specific IgE Assay and ImmunoCAP Specific IgE Conjugate 100 and Conjugate 400 ([K051218](/device/K051218.md))
- ImmunoCAP Specific IgE Assay ([K962274](/device/K962274.md) and [K974580](/device/K974580.md))

## Submission Summary (Full Text)

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>
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM

A. 510(k) Number:
K150854

B. Purpose for Submission:
Addition of four new recombinant allergens and one purified native allergen to a cleared device

C. Measurand:
Five new allergen-specific IgE analytes: f439, rCor a 14 (Hazelnut); f440, nCor a 9 (Hazelnut); f441, rJurg r 1 (Walnut); f442, rJurg r 3 (Walnut); f443, rAna o 3 (Cashew nut)

D. Type of Test:
Fluoroenzymeimmunoassay, Quantitative

E. Applicant:
Phadia AB

F. Proprietary and Established Names:
ImmunoCAP Specific IgE

Additions include:
ImmunoCAP Allergen f439, Allergen component rCor a 14, Hazelnut, 14-5754-01
ImmunoCAP Allergen f440, Allergen component nCor a 9, Hazelnut, 14-5758-01
ImmunoCAP Allergen f441, Allergen component rJug r 1, Walnut, 14-5762-01
ImmunoCAP Allergen f442, Allergen component rJug r 3, LTP, Walnut, 14-5954-01
ImmunoCAP Allergen, f443, Allergen component rAna o 3, Cashew nut, 14-5760-01

G. Regulatory Information:

1. Regulation section:
21 CFR § 866.5770, Radioallergosorbent (RAST) immunological test system

2. Classification:
Class II

3. Product code:
DHB – System, Test, Radioallergosorbent (RAST), Immunological

4. Panel:

{1}

Immunology (82)

## H. Intended Use:

1. Intended use(s):

ImmunoCAP Specific IgE is an *in vitro* quantitative assay for the measurement of allergen specific IgE in human serum or plasma (EDTA or Na-Heparin). ImmunoCAP Specific IgE is to be used with instruments Phadia 100, Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000. It is intended for *in vitro* diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings, and is to be used in clinical laboratories.

2. Indication(s) for use:

Same as intended use.

3. Special conditions for use statement(s):

For prescription use only.

4. Special instrument requirements:

For use on the instruments Phadia 100, Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000

## I. Device Description:

The ImmunoCAP system is a fully integrated and automated system for the determination of specific IgE in human blood serum or plasma (EDTA or Na-Heparin) sample. It is comprised of general, test and method specific reagents for Phadia 100, Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000 test system modules, as well as instrument and data management software.

The general ImmunoCAP reagents include ImmunoCAP Specific IgE Conjugate, ImmunoCAP Specific IgE Curve Control, ImmunoCAP Specific IgE Calibrators, Specific IgE anti-IgE ImmunoCAP, Allergen ImmunoCAP carriers, ImmunoCAP development solution and stop solution. The method specific reagents consist of individual purified allergen (native or recombinant) covalently coupled to a support in a plastic housing.

## J. Substantial Equivalence Information:

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

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

ImmunoCAP Specific IgE Assay (K962274 and K974580)

2. Comparison with predicate:

|  Similarities  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|  Intended Use | An in vitro quantitative assay for the | Same  |

{2}

|  Similarities  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|   | measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings and to be used in clinical laboratories. |   |
|  Assay type | Quantitative | Same  |
|  Basic principle | Fluoroenzymeimmunoassay | Same  |
|  Detection antibody | β-Galactosidase-anti-human IgE (mouse monoclonal antibody) | Same  |
|  Sample volume | 40 μL | Same  |
|  Number of calibrators | Six | Same  |
|  Process time | Phadia 100: 2 hrs 30 min. Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000: 1 hour 45 minutes from entering the first sample. | Same  |
|  Incubation temperature | 37°C | Same  |
|  Differences  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|  Form of allergens | Recombinant proteins and a purified native allergen | Purified native allergens  |
|  Allergens | Individual recombinant proteins: f439, rCor a 14 (Hazelnut); f441, rJurg r 1 (Walnut); f442, rJurg r 3, LTP (Walnut); f443, rAna o 3 (Cashew nut)Individual purified native allergen source: f440, nCor a 9 (Hazelnut) | Whole allergen from purified native allergen source: f17 (Hazelnut; f256 (Walnut); f202 (Cashew nut)  |
|  Sample matrix | Serum and plasma (EDTA or sodium heparin) | Serum and plasma (EDTA and heparin)  |
|  Laboratory settings | Clinical laboratories | Clinical laboratories and physician office laboratories  |
|  Instruments | Phadia 100, Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000 | UniCAP 100  |
|  Built-in Software versions | Phadia 100: 3.08Phadia 250: 2.33Phadia 1000: 2.40Phadia 2500: 1.42Phadia 5000: 1.42Phadia Information Data Manager | Not available  |

{3}

|  Differences  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|   | (IDM): 5.67 |   |

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

CLSI EP5-A2: Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline - Second Edition.

CLSI EP7-A2: Interference testing in Clinical Chemistry; Approved Guideline - Second Edition.

CLSI EP17-A: Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline.

CLSI EP25-A: Evaluation of stability of in vitro diagnostic reagents; Approved Guideline.

CLSI I/LA20-A2: Analytical Performance Characteristics and Clinical Utility of Immunological Assays for Human Immunoglobulin E (IgE) Antibodies and Defined Allergy Specificities; Approved Guidelines - Second Edition.

CEN 13640: 2002 Stability Testing of in vitro Diagnostic Reagents

# L. Test Principle:

The allergen of interest, covalently coupled to ImmunoCAP solid phase, reacts with the specific IgE in the patient sample. After washing away nonspecific IgE, enzyme-labeled antibodies against IgE are added to form a complex. After incubation, unbound enzyme-anti-IgE is washed away and the bound complex is then incubated with a developing agent. After stopping the reaction, the fluorescence of the eluate is measured. The higher the response value, the more specific IgE is present in the specimen. To evaluate the test results, the responses for the patient samples are transformed to concentrations with the use of a calibration curve.

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

# 1. Analytical performance:

# a. Precision/Reproducibility:

i) Within-Lot imprecision:

Imprecision of the individual allergen components was evaluated by using two positive plasma samples, including a low range sample  $(0.35\pm 25\%)$  and a high range sample  $(\geq 0.7\mathrm{kU}_{\mathrm{A}} / \mathrm{L})$ . Each sample was tested in 4 replicates in one assay run per day for a total of 20 operating days (a total of 80 replicates per sample). The assay was performed according to the ImmunoCAP Specific IgE Directions for Use using Phadia 250. Between-day and within-run coefficients of variance (%CV) were calculated for each component and each sample separately. Results of CV% values for individual allergen components were all within the acceptance criteria and are shown below:

|  ImmunoCAP Allergen Component | Sample | Number of tests | Mean (kU/L) | CV% Between Days | CV% Within-run | CV% Total  |
| --- | --- | --- | --- | --- | --- | --- |
|  f439, rCor a 14 (Hazelnut) | 1 | 80 | 1.70 | 2.44 | 2.24 | 3.31  |
|   |  2 | 80 | 0.40 | 3.03 | 2.95 | 4.22  |
|  f440, nCor a 9 | 1 | 80 | 1.44 | 2.53 | 2.04 | 3.25  |

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|  ImmunoCAP Allergen Component | Sample | Number of tests | Mean (kU/L) | CV% Between Days | CV% Within-run | CV% Total  |
| --- | --- | --- | --- | --- | --- | --- |
|  (Hazelnut) | 2 | 80 | 0.28 | 3.36 | 4.67 | 5.75  |
|  f441, rJurg r 1 (Walnut) | 1 | 80 | 1.84 | 4.14 | 4.97 | 6.47  |
|   |  2 | 80 | 0.38 | 1.98 | 2.05 | 2.85  |
|  f442, rJurg r 3, LTP (Walnut) | 1 | 80 | 2.76 | 2.06 | 2.22 | 3.03  |
|   |  2 | 80 | 0.35 | 5.19 | 4.11 | 6.62  |
|  f443, rAna o 3 (Cashew nut) | 1 | 80 | 2.50 | 2.34 | 2.40 | 3.35  |
|   |  2 | 80 | 0.28 | 3.24 | 9.39 | 9.93  |

Results of pooled CV% values for individual allergens:

|  ImmunoCAP Allergen Component | Number of samples | CV% Between Days | CV% Within-run | CV% Total  |
| --- | --- | --- | --- | --- |
|  f439, rCor a 14 (Hazelnut) | 2 | 2.75 | 2.62 | 3.79  |
|  f440, nCor a 9 (Hazelnut) | 2 | 2.97 | 3.60 | 4.67  |
|  f441, rJurg r 1 (Walnut) | 2 | 3.24 | 3.80 | 5.00  |
|  f442, rJurg r 3, LTP (Walnut) | 2 | 3.95 | 3.30 | 5.15  |
|  f443, rAna o 3 (Cashew nut) | 2 | 2.83 | 6.85 | 7.41  |

ii) Lot-to-lot imprecision:

For each allergen, three different ImmunoCAP Allergen Component lots were tested using two positive plasma samples (0.35 ± 25% and ≥ 0.7 kU_A/L) and one negative plasma sample (< 0.1 kU_A/L). For each lot, the samples were tested in 12 replicates in one assay run. Each lot represented a different preparation of the allergen from routine production. The assay was performed according to the ImmunoCAP Specific IgE, Directions for Use, using the Phadia 250 instrument. Mean concentration values, %CV and concentration quotients between lots were calculated for the positive samples were all within the acceptance criteria and are shown below.

|  Lot | Positive 1 |   | Positive 2 |   | Negative | Concentration Quotient  |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |  Mean (kU_A/L) | CV (%) | Mean (kU_A/L) | CV (%) | Mean (kU_A/L) |  | Positive 1 | Positive 2  |
|  ImmunoCAP Allergen, f439, rCor a 14 (Hazelnut)  |   |   |   |   |   |   |   |   |
|  1 | 1.76 | 2.9 | 0.36 | 1.4 | <0.1 | lot1/lot2 | 1.03 | 1.10  |
|  2 | 1.71 | 1.18 | 0.33 | 1.3 | <0.1 | lot1/lot3 | 0.99 | 1.03  |
|  3 | 1.78 | 2.1 | 0.35 | 2.4 | <0.1 | lot2/lot3 | 0.96 | 0.94  |
|  ImmunoCAP Allergen, f440, nCor a 9 (Hazelnut) |   |   |   |   |   |   |   |   |
|  1 | 2.57 | 1.89 | 0.34 | 3.29 | <0.1 | lot1/lot2 | 1.03 | 1.08  |
|  2 | 2.49 | 1.49 | 0.31 | 2.17 | <0.1 | lot1/lot3 | 1.04 | 1.08  |
|  3 | 2.47 | 1.95 | 0.31 | 5.50 | <0.1 | lot2/lot3 | 1.01 | 1.00  |
|  ImmunoCAP Allergen, f441, rJurg r 1 (Walnut)  |   |   |   |   |   |   |   |   |
|  1 | 1.72 | 2.5 | 0.38 | 3.8 | <0.1 | lot1/lot2 | 1.05 | 1.02  |
|  2 | 1.65 | 2.0 | 0.37 | 2.3 | <0.1 | lot1/lot3 | 1.06 | 1.00  |
|  3 | 1.63 | 2.0 | 0.38 | 2.0 | <0.1 | lot2/lot3 | 1.01 | 0.99  |
|  ImmunoCAP Allergen, f442, rJurg r 3, LTP (Walnut)  |   |   |   |   |   |   |   |   |

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|  Lot | Positive 1 |   | Positive 2 |   | Negative | Concentration Quotient  |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |  Mean (kUA/L) | CV (%) | Mean (kUA/L) | CV (%) | Mean (kUA/L) |  | Positive 1 | Positive 2  |
|  1 | 3.74 | 2.5 | 0.36 | 5.3 | <0.1 | lot1/lot2 | 0.95 | 0.90  |
|  2 | 3.95 | 2.3 | 0.40 | 6.0 | <0.1 | lot1/lot3 | 0.94 | 0.90  |
|  3 | 3.99 | 2.7 | 0.40 | 5.9 | <0.1 | lot2/lot3 | 0.99 | 1.00  |
|  ImmunoCAP Allergen, f443, rAna o 3 (Cashew nut)  |   |   |   |   |   |   |   |   |
|  1 | 2.92 | 3.3 | 0.40 | 1.2 | <0.1 | lot1/lot2 | 1.01 | 1.00  |
|  2 | 2.89 | 2.4 | 0.40 | 11.6 | <0.1 | lot1/lot3 | 0.98 | 1.11  |
|  3 | 2.98 | 2.3 | 0.36 | 4.6 | <0.1 | lot2/lot3 | 0.97 | 1.11  |

b. Linearity/assay reportable range:

The linearity of the individual allergens was assessed following the CLSI I/LA20-A2 guidelines. For each allergen component, three positive plasma samples were each diluted in negative plasma generating at least five 2-fold consecutive dilutions. Undiluted samples were tested in 12 replicates and diluted samples were tested in four replicates in one assay run. The assay was performed according to the ImmunoCAP Specific IgE, Directions for Use using the Phadia 250 instrument. For each product, one lot of ImmunoCAP Allergen Component was used. The working range of the ImmunoCAP Specific Total IgE is LoD to 100 kUA/L.

For each allergen, results of the replicates from all three samples were pooled and analyzed for linearity. Regression statistics for each allergen comparing the observed results to expected results are presented below:

|  ImmunoCAP Allergen Component | Regression Equation | r² | 95% CI Slope | 95% CI Intercept | Highest concentration tested (kU_A/L)  |
| --- | --- | --- | --- | --- | --- |
|  f439, rCor a 14 (Hazelnut) | y = 0.99x + 0.03 | 1.00 | 0.98–1.00 | 0.02–0.03 | 26.9  |
|  f440, nCor a 9 (Hazelnut) | y = 0.96x – 0.10 | 1.00 | 0.94–0.97 | 0.08–0.11 | 47.9  |
|  f441, rJurg r 1 (Walnut) | y =1.00x | 1.00 | 0.99–1.00 | 0–0 | 63.3  |
|  f442, rJurg r 3, LTP (Walnut) | y =0.97x + 0.05 | 1.00 | 0.96–0.98 | 0.04–0.05 | 55.6  |
|  f443, rAna o 3 (Cashew nut) | y =1.03x + -0.03 | 1.00 | 1.03–1.02 | -0.04–(-0.02) | 22.3  |

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

i) Traceability:

The IgE calibrators are traceable (via an unbroken chain of calibrations) to the 2nd International Reference Preparation (IRP) 75/502 of Human Serum Immunoglobulin E from World Health Organization (WHO).

ii) Kit Stability:

Real-time and accelerated stability: The stability studies were performed in accordance with EN 13640 (Stability Testing of In Vitro Diagnostic Reagents) to demonstrate 24 month unopened shelf-life stability (from the date of manufacture when stored at the

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recommended storage temperature of  $2 - 8^{\circ}\mathrm{C}$ ) on three lots each of: ImmunoCAP Allergen f439, rCor a 14 (Hazelnut); f440, nCor a 9 (Hazelnut); f441, rJurg r 1 (Walnut); f442, rJurg r 3, LTP (Walnut); f443, rAna o 3 (Cashew nut) by an ongoing real-time stability study and accelerated stability study. All stability data support the manufacturer's claim of 24 months.

The stability of the calibration curve, real-time, and on-board stability of ImmunoCAP Specific IgE calibrator are detailed in K100999.

# d. Detection limit:

The Limit of Blank (LoB) and Limit of Detection (LoD) were determined for each allergen component on the Phadia 250 in alignment with CLSI EP17-A. The LoB was based on single determinations of 100 negative samples (blank samples) and was estimated as the  $95\%$  percentile of the distribution. LoD was calculated according to the equation:  $\mathrm{LoD} = \mathrm{LoB} + \mathrm{c}\beta \times \mathrm{SD}$  where SD, the standard deviation, was based on 20 determinations of 3 low positive samples, in total 60 determinations. The results are shown in the table below.

|  ImmunoCAP Allergen Component | LoB (kUA/L) | LoD (kUA/L)  |
| --- | --- | --- |
|  f439, rCor a 14 (Hazelnut) | 0.007 | 0.013  |
|  f440, nCor a 9 (Hazelnut) | 0.002 | 0.008  |
|  f441, rJurg r 1 (Walnut) | 0.008 | 0.015  |
|  f442, rJurg r 3, LTP (Walnut) | 0.014 | 0.037  |
|  f443, rAna o 3 (Cashew nut) | 0.000 | 0.008  |

# e. Analytical specificity:

# i) Inhibition studies:

Immunological specificity of the allergen components was verified through competitive inhibition. The studies were planned in accordance with CLSI I/LA20-A2. The specific IgE concentration for the positive samples is shown in the table below.

|  ImmunoCAP Allergen Component | kUA/L  |
| --- | --- |
|  f439, rCor a 14 (Hazelnut) | 4.7  |
|  f440, nCor a 9 (Hazelnut) | 10.2  |
|  f441, rJurg r 1 (Walnut) | 4.5  |
|  f442, rJurg r 3, LTP (Walnut) | 8.0  |
|  f443, rAna o 3 (Cashew nut) | 5.4  |

The allergen solution was serially diluted with buffer to show an overall dose dependent inhibition. Equal volumes of a positive sample and varying dilutions of allergen solution (inhibitor) were premixed. The mixture was incubated in a sample tube at room temperature for 1 hour before being analyzed with the corresponding ImmunoCAP Allergen Component on the Phadia 250 according to the ImmunoCAP Specific IgE, Directions for Use. The testing was performed in duplicate in one assay run. Mean values were calculated.

The inhibition test was evaluated with inhibition values in  $\%$  calculated according to the formula below:

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$$
\left(1 - \left(\frac {r - b}{t - b}\right)\right) \times 100 = i \%
$$

r = response [RU]
b = background response (100% inhibition) [RU]
t = total response (0% inhibition) [RU]
i = inhibition

Any negative inhibition %-values are shown as 0% inhibition.

The results of the inhibition with the allergen solution and the unrelated inhibitors indicate that the five new ImmunoCAP Allergen Components contain the immunologically relevant allergen as shown below:

**ImmunoCAP Allergen**, f439, Allergen Component_rCor a 14 (Hazelnut)

The f439, rCor a 14 (Hazelnut) allergen Inhibition study showed that &gt;50% inhibition was achieved with the related inhibitor (rCor a 14 allergen) at a final inhibitor concentration of 0.92 mg/mL. The inhibition studies using four unrelated inhibitors, including three from unrelated groups (rPla l 1, Plantain; rPla a 1, London Plane; and rFel d 2, Cat) and one from the related/same group (rCor a 8, Hazelnut) did not show any significant inhibition. The inhibition studies indicate that the ImmunoCAP Allergen f439, rCor a 14 (Hazelnut) solid phase contains the immunologically relevant allergen.

**ImmunoCAP Allergen**, f440, Allergen Component_nCor a 9 (Hazelnut)

The f440, nCor a 9 (Hazelnut) allergen Inhibition study showed that &gt;50% inhibition was achieved with the related inhibitor (nCor a 9 allergen) at a final inhibitor concentration of 22 µg/mL. The inhibition studies using four unrelated inhibitors, including three from unrelated groups (nAmb a 1, Ragweed; rOle e 9, Olive; and rCan f 5, Dog) and one from the related/same group (rCor a 1, Hazelnut) did not show any significant inhibition. The inhibition studies indicate that the ImmunoCAP Allergen f440, nCor a 9 (Hazelnut) solid phase contains the immunologically relevant allergen.

**ImmunoCAP Allergen**, f441, Allergen Component rJug r 1 (Walnut)

The f441, rJug r 1 (Walnut) allergen Inhibition study showed that &gt;50% inhibition was achieved with the related inhibitor (rJug r 1 allergen) at a final inhibitor concentration of 23 µg/mL. The inhibition studies using four unrelated inhibitors, including three from unrelated groups (rCan f 4, Dog; rOle e 9, Olive; and rPla l 1, Plantain) and one from the related/same group (rJug r 3, Walnut) did not show any significant inhibition. The inhibition studies indicate that the ImmunoCAP Allergen f441, rJug r 1 (Walnut) solid phase contains the immunologically relevant allergen.

**ImmunoCAP Allergen**, f442, Allergen Component rJurg r 3 (Walnut)

The f442, rJurg r 3 (Walnut) allergen Inhibition study showed that &gt;50% inhibition was achieved with the related inhibitor (rJug r 3 allergen) at a final inhibitor concentration of 19 mg/mL. The inhibition studies using four unrelated inhibitors, including three from unrelated groups (rCan f 4, Dog; rOle e 9, Olive; and rPla l 1, Plantain) and one from the related/same group (rJurg r 1, Walnut) did not show any significant inhibition. The inhibition studies indicate that the ImmunoCAP Allergen f442, rJurg r 3 (Walnut) solid phase contains the immunologically relevant allergen.

**ImmunoCAP Allergen**, f443, Allergen Component_rAna o 3 (Cashew nut)

The f443, rAna o 3 (Cashew nut) allergen Inhibition study showed that &gt;50% inhibition

8

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was achieved with related inhibitor (rAna o 3 allergen) at a final inhibitor concentration of 43 µg/mL. The inhibition studies using four unrelated inhibitors, including three from unrelated groups (nAmb a 1, Ragweed; rOle e 9, Olive; and rCan f 5, Dog) and one from the related/same group (rCor a 1, Hazelnut) did not show any significant inhibition. The inhibition studies indicate that the ImmunoCAP Allergen f443, rAna o 3 (Cashew nut) solid phase contains the immunologically relevant allergen.

ii) Interference:

a) Endogenous Substance Interference:

In order to show that icteric, hemolytic or lipemic samples do not adversely affect the results in ImmunoCAP Specific IgE assay using representative allergens, Bilirubin C [final concentration (fc) 20 mg/dL], Bilirubin F (fc 19 mg/dL), Hemoglobin (fc 489 mg/dL) and Chyle (fc 1,440 Formazine Turbidity Units) were spiked into 2 samples per allergen and were analyzed in duplicates in one assay run using Phadia 250. Refer to K1138441. The results demonstrate that icteric, hemolytic or lipemic samples do not adversely affect the results in ImmunoCAP Specific IgE.

b) Exogenous Substance Interference:

Two literature references were provided supporting that commonly prescribed "allergy medications" do not interfere with ImmunoCAP Specific IgE. The references included (i) Robert G. Hamilton, Accuracy of US Food and Drug Administration-cleared IgE antibody assays in the presence of anti-IgE (omalizumab), J. Allergy Clin. Immunol. 2006; 759-766, and (ii) Linda Cox et. al., Pearls and pitfalls of allergy diagnostic testing: report from the American College of Allergy, Asthma and Immunology/American Academy of Allergy, Asthma and Immunology Specific IgE Test Task Force, Annals of Allergy, Asthma &amp; Immunology, 2008; 101:580-592.

f. Assay cut-off:

Limit of Quantitation for ImmunoCAP Specific IgE is 0.1 kU/L. All results &gt;0.1 kU/L are interpreted as being analytically positive.

2. Comparison studies:

a. Method comparison with predicate device:

Not applicable

b. Matrix comparison:

In order to show that different sample matrices (heparin plasma, EDTA plasma and serum) are interchangeable for ImmunoCAP Allergen Components, serum, sodium heparin plasma, and EDTA plasma samples were collected from four patients with clinical history of known specific allergies and four non-atopic patients. The samples contained specific IgE antibodies for one or more of the allergen components tested. All sample matrices (heparin plasma, EDTA plasma and serum) from each patient were tested with ImmunoCAP Allergen Components in two replicates in one assay run. The results from the study demonstrate that samples of different matrices (heparin plasma, EDTA plasma and serum) are interchangeable for ImmunoCAP Allergen Components. Refer to K101251.

3. Clinical studies:

a. Clinical sensitivity and specificity:

9

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The performance of the five new individual allergen components was compared to a clinical diagnosis of allergy. The objectives of this study were: (i) to show the linkage between specific IgE antibodies to ImmunoCAP Allergen Component and the corresponding extract based ImmunoCAP Allergen, using clinical samples, and (ii) to demonstrate that samples from healthy, non-atopic donors with no reported clinical reaction to the allergen have undetectable or very low levels of specific IgE to the individual ImmunoCAP Allergen Component. Thirty or more clinical serum samples from individuals with a clinical history of allergy-like symptoms upon exposure to the allergen, as diagnosed by a physician were used in the study. Information about clinical symptoms and manifestations was available for all clinical samples. Negative samples (&lt;0.35 kU_A/L) from 100 healthy non-atopic donors were also tested.

ImmunoCAP Allergen f439, Allergen Component rCor a 14 (Hazelnut)

|   | Clinical Diagnosis  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Atopic | Non-atopic | Total  |
|  Allergen, f439, rCor a 14 (Hazelnut) | Positive | 31 | 0 | 31  |
|   |  Negative | 1 | 100 | 101  |
|   |  Total | 32 | 100 | 132  |

Sensitivity =96.9% (31/32) (95% CI: 83.8–99.9%)
Specificity =100% (100/100) (95% CI: 96.4–100%)

ImmunoCAP Allergen f440, Allergen Component nCor a 9 (Hazelnut)

|   | Clinical Diagnosis  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Atopic | Non-atopic | Total  |
|  Allergen, f440, nCor a 9 (Hazelnut) | Positive | 27 | 0 | 27  |
|   |  Negative | 3 | 100 | 103  |
|   |  Total | 30 | 100 | 130  |

Sensitivity =90% (27/30) (95% CI: 73.5–97.9%)
Specificity =100% (100/100) (95% CI: 96.4–100.0%)

ImmunoCAP Allergen f441, Allergen Component rJurg r 1 (Walnut)

|   | Clinical Diagnosis  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Atopic | Non-atopic | Total  |
|  Allergen, f441, rJurg r 1 (Walnut) | Positive | 37 | 0 | 37  |
|   |  Negative | 2 | 100 | 102  |
|   |  Total | 39 | 100 | 139  |

Sensitivity =95% (37/39) (95% CI: 82.7–99.4%)
Specificity =100% (100/100) (95% CI: 96.4–100%)

10

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ImmunoCAP Allergen f442, Allergen Component rJurg r 3, LTP (Walnut)

|   | Clinical Diagnosis  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Atopic | Non-atopic | Total  |
|  Allergen, f442, rJurg r 3, LTP (Walnut) | Positive | 25 | 0 | 25  |
|   |  Negative | 5 | 100 | 105  |
|   |  Total | 30 | 100 | 130  |

Sensitivity =83.3% (25/30) (95% CI: 65.3 – 94.4%)
Specificity =100% (100/100) (95% CI: 96.4–100%)

ImmunoCAP Allergen f443, Allergen Component rAna o 3 (Cashew nut)

|   | Clinical Diagnosis  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Atopic | Non-atopic | Total  |
|  Allergen, f443, rAna o 3 (Cashew nut) | Positive | 27 | 0 | 27  |
|   |  Negative | 4 | 100 | 104  |
|   |  Total | 31 | 100 | 131  |

Sensitivity =87% (27/31) (95% CI: 70.2–96.4%)
Specificity =100% (100/100) (95% CI: 96.4–100%)

All negative samples showed an undetectable level (&lt; 0.35 kU_A/L) of allergen specific IgE. Studies described above were performed on the Phadia 1000 instrument system.

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

Not applicable

4. Clinical cut-off:

Not applicable

5. Expected values/Reference range:

The expected value is negative (&lt; 0.35 kU_A/L) for a specific allergen in a non-allergic person. The manufacturer recommends a cut-off at 0.35 kU_A/L. Each laboratory should establish its own expected range of values.

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/K150854](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHB/K150854)

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