← Product Code [DHB](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHB) · K182793

# AP3600 Automated Instrument (K182793)

_Hitachi Chemical Diagnostics, Inc. · DHB · Mar 19, 2019 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHB/K182793

## Device Facts

- **Applicant:** Hitachi Chemical Diagnostics, Inc.
- **Product Code:** [DHB](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHB.md)
- **Decision Date:** Mar 19, 2019
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5750
- **Device Class:** Class 2
- **Review Panel:** Immunology

## Indications for Use

The AP 3600 Automated Instrument, in conjunction with the OPTIGEN Allergen-Specific IgE Assay, is for the semiquantitative measurement of circulating allergen-specific IgE antibodies in human serum. The OPTIGEN Allergen-Specific IgE Assay is intended to aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings. The AP 3600 Automated Instrument is a software-enabled instrument designed for use with the OPTIGEN Allergen-Specific IgE Assay in clinical laboratories for sample processing, measurement analyses, and reporting of OPTIGEN Allergen-Specific IgE Assay results.

## Device Story

AP 3600 Automated Instrument processes OPTIGEN Allergen-Specific IgE Assays; automates manual steps including pette re-hydration, serum/reagent loading, incubation, washing, and photoreagent addition. Input: patient serum samples in vials. Operation: nozzle heads dispense samples/reagents into allergen-coated pette chambers; enzyme-labeled anti-IgE binds to patient IgE; photoreagent mixture added; chemiluminescence generated. Output: light emission measured by internal photomultiplier tube; converted to Luminometer Count (LMC) units; assigned Class 0-6 score. Used in clinical laboratories by professional staff. Instrument software subtracts Negative Blanking Control from allergen emission levels to calculate IgE response. Benefits: fully automated processing replaces semi-automated predecessor (AP 720S); improves throughput and standardization of optical readings via NIST-traceable electronic calibrators.

## Clinical Evidence

Method comparison study performed against Thermos Fisher ImmunoCAP using 2902 serum samples (positive and negative). Results: PPA 92.8%, NPA 95.7%, TPA 94.9%. Disagreement analysis showed 73.5% of discordant results were within one class. Precision assessed per CLSI EP05-A3 with 23 pooled serum samples across 40-42 runs; total %CV ranged from 10-36% depending on class. Linearity demonstrated per CLSI EP6-A (r2 0.96-0.99). LoB/LoD determined per CLSI EP17-A2.

## Technological Characteristics

Chemiluminescence immunoassay system. Materials: disposable pettes, sample cups, transfer tips. Energy: electrical. Connectivity: internal software-controlled reader, barcode scanning. Sterilization: N/A (disposable components). Software: automated processor, internal photomultiplier tube. Standards: CLSI EP05-A3, EP6-A, EP17-A2.

## 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.

## Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM INSTRUMENT ONLY TEMPLATE

A. 510(k) Number:
K182793

B. Purpose for Submission:
This submission is for modification of the OPTIGEN Allergen-Specific IgE Assay System. The modified version is the AP 3600 Automated Instrument that provides fully automated assay processing.

C. Manufacturer and Instrument Name:
Hitachi Chemical Diagnostics, Inc., OPTIGEN AP 3600 Automated Instrument

D. Type of Test or Tests Performed:
Chemiluminescent, Allergen-specific IgE assay

E. System Descriptions:

1. Device Description:
The AP 3600 Automated Instrument is a modification of its predecessor product AP 720STM Semi-automated Instrument cleared under K112910. The difference between the two systems is that the modification includes a fully automated processor and does not require the pette to be removed from the instrument for optical reading of test results with the CLA-1 luminometer. The AP 3600 Automated instrument re-hydrates the pette, loads the patient serum sample, incubates for two hours, washes, adds the antibody reagent, incubates for two hours, washes and adds the photoreagent mixture before reading test results. The instrument utilizes its own software-controlled reader to convert light output emitted by the device into Luminometer Count (LMC) units and assigns a class value that can be used as a semi-quantitative estimate of specific IgE levels. The AP 3600 Automated Instrument comes with the OPTIGEN AP 3600 Automated Instrument User Manual.

2. Principles of Operation:
The AP 3600 Automated Instrument is a software controlled system that includes a processor to automate the manual steps of the OPTIGEN Allergen-Specific IgE Assay, from the device re-hydration step to loading of patient serum and reagents and reading of test results after the introduction of photoreagent. Three nozzle heads (sample, reagent,

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and wash) in the instrument drive the pette down to open the pette tip for wash or loading of patient sera or reagent. IgE antibodies in the patient sera bind to allergen-coated wells of the pette test chambers. After an incubation period, the pette is washed with buffer solution to remove any unbound serum components. An enzyme-labeled anti-IgE antibody is introduced into the pette that binds to the IgE bound to the wells. After a second washing, the pette is filled with a Photoreagent mixture which, when combined with the enzyme-labeled anti-IgE antibody gives off a chemically generated light (i.e. chemiluminescence). The amount of light emitted by each well is directly proportional to the amount of allergen-specific IgE in the patient's serum. A photomultiplier tube unit in the instrument measures the chemiluminescence light emitted and converts the light output into Luminometer Count (LMC) units. To calculate the patient's IgE response, the instrument automatically subtracts the emission level of the Negative Blanking Control from the emission level of each allergen. AP 3600 Class Values are assigned from 0 to 6 based on the amount of light emitted by the individual allergens in the pette. The amounts of IgE associated with AP 3600 Class values and instrument readings are listed in the following table.

|  AP 3600 Class Allergy Scoring System of the OPTIGEN Allergen-Specific IgE Assay  |   |   |
| --- | --- | --- |
|  AP 3600™ Class | LMC | Levels of allergen-Specific IgE Concentration  |
|  0 | 0-500 | No antibodies detected  |
|  1 | 501-1500 | Low levels of antibodies  |
|  2 | 1501-7000 | Moderate levels of antibodies  |
|  3 | 7001-36000 | High levels of antibodies  |
|  4 | 36001-72000 | Very high levels of antibodies  |
|  5 | 72001-150000  |   |
|  6 | 150001-500000  |   |

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

Yes ☐ X ☐ or No ☐

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

Yes ☐ X ☐ or No ☐

4. Specimen Identification:

The operator places the sample vials in a rack and loads up to five racks with a maximum of ten vials each, one at a time, for scanning of sample barcodes.

5. Specimen Sampling and Handling:

Sample collection, preparation and storage are described in the Package Insert. After the

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sample barcodes are scanned, the distribution dispensing nozzle head uses single-use disposable transfer tips to transfer sera samples from the vials in a rack into the sample cups for the assay. If the dilution method is used, the Sample Diluent Dispensing Head dispenses Sample Diluent into the sample cups before samples are transferred to the sample cups.

6. Calibration:

NIST traceable electronic calibrators (Calibrator II) are used to standardize the optical readings across AP 3600 instruments. A calibration factor is calculated as the ratio of the Expected Value printed on the label of the Calibrator divided by the Actual Value that is generated by running the calibrator on the instrument.

7. Quality Control:

The device contains a Positive Procedural Control as well as a Negative Blanking Control. The Positive Procedural Control checks the performance of kit reagents. The Positive Procedural Control must generate a reading greater than or equal to 12500 LMC in the AP 3600. The Negative Blanking Control compensates for any nonspecific IgE binding that may occur. The Negative Blanking Control must generate a reading of equal to or less than 1500 LMC in the AP 3600.

8. Software:

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

Yes ☐ X or No ☐

F. Regulatory Information:

1. Regulation section:

21 CFR § 866.5750, Radioallergosorbent (RAST) immunological test system

2. Classification:

Class II

3. Product code:

DHB - System, Test, Radioallergosorbent (RAST), Immunological

4. Panel:

Immunology (82)

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G. Intended Use:

1. Indications for Use:

The AP 3600 Automated Instrument, in conjunction with the OPTIGEN Allergen-Specific IgE Assay, is for the semi-quantitative measurement of circulating allergen-specific IgE antibodies in human serum. The OPTIGEN Allergen-Specific IgE Assay is intended to aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings. The AP 3600 Automated Instrument is a software-enabled instrument designed for use with the OPTIGEN Allergen-Specific IgE Assay in clinical laboratories for sample processing, measurement analyses, and reporting of OPTIGEN Allergen-Specific IgE Assay results.

2. Special Conditions for Use Statement:

For Prescription Use Only

H. Substantial Equivalence Information:

1. Predicate Device Names and 510(k) numbers:

OPTIGEN AP 720S Semi-Automated Instrument, K112910.

ImmunoCAP Specific IgE Assay and ImmunoCAP Specific IgE Conjugate 100 and Conjugate 400, K051218

2. Comparison with Predicate Devices:

|  Similarities  |   |   |
| --- | --- | --- |
|  Item | New Device
OPTIGEN AP 3600 Automated Instrument | Predicate
OPTIGEN AP 720S Semi-Automated Instrument  |
|  Indications for Use Statement | The AP 3600 Automated Instrument, in conjunction with the OPTIGEN Allergen-Specific IgE Assay, is for the semi-quantitative measurement of circulating allergen-specific IgE antibodies in human serum. The OPTIGEN Allergen-Specific IgE Assay is intended to aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings. The AP 3600 Automated Instrument is a software-enabled instrument designed for use with the OPTIGEN Allergen-Specific IgE Assay in clinical laboratories. | The AP 720S Semi-Automated Instrument is a semi-automated processor for use with the OPTIGEN Assay. The OPTIGEN Assay is an in vitro diagnostic test for use in the semi-quantitative determination of circulating allergen-specific IgE concentrations in human serum. It is intended to aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings. The device is designed for use in clinical laboratories.  |

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|  Similarities  |   |   |
| --- | --- | --- |
|  Item | New Device OPTIGEN AP 3600 Automated Instrument | Predicate OPTIGEN AP 720S Semi-Automated Instrument  |
|   | IgE Assay in clinical laboratories for sample processing, measurement analyses, and reporting of OPTIGEN Allergen-Specific IgE Assay results. |   |
|  Reagent Component | Fully integrated disposable pettes | Same  |
|  Testing Environment | Professional use | Same  |
|  Sample Type | Serum | Same  |
|  Methodology | Chemiluminescence Immunoassay | Same  |
|  Assay Format | Semi-quantitative | Same  |
|  Processing Temperature | 18–30°C | Same  |
|  Antibody Reagent | Enzyme-labeled goat anti-human IgE | Same  |
|  Consumables | Sample cups, transfer tips, pettes, pipette tips, reagent bottles, wash buffer concentrate bottles | Same  |
|  Differences  |   |   |
| --- | --- | --- |
|  Item | New Device OPTIGEN AP 3600 Automated Instrument | Predicate OPTIGEN AP 720S Semi-Automated Instrument  |
|  System Configuration | AP 3600 + pettes + consumables | AP 720 STM processor + luminometer + Pettes + consumables  |
|  Sample Processing | Fully automated | Semi-automated  |
|  Sample Volume | 600 uL | 490 uL  |
|  Calibration/Reader Performance Check | Yes | No  |
|  Throughput | Approximately 5.5 hours for 50 pettes | Approximately 4.75 hours for 20 pettes  |
|  Reported Unit | Luminometer Count (LMC) | Luminescence Unit (LU)  |
|  Light Source | Internal reference light within instrument | External, provided by a separate reader  |
|  Reader | Included in AP 3600 | CLA-1 Luminometer  |
|  Class Allergy Scoring System of the OPTIGEN Allergen-Specific IgE Assay | AP 3600 Class 0 to Class 6 | CLA Class 0 to Class 4  |
|  Quality Control | Positive Procedural Control: ≥12500 LMC Negative Blanking Control: <1500 LMC | Positive Procedural Control: ≥243 LU Negative Blanking Control: <69 LU  |

{5}

|  Similarities  |   |   |
| --- | --- | --- |
|  Item | New Device OPTIGEN AP 3600 Automated Instrument | Predicate Phadia ImmunoCAP  |
|  Indications for Use Statement | The AP 3600 Automated Instrument, in conjunction with the OPTIGEN Allergen-Specific IgE Assay, is for the semi-quantitative measurement of circulating allergen-specific IgE antibodies in human serum. The OPTIGEN Allergen-Specific IgE Assay is intended to aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings. The AP 3600 Automated Instrument is a software-enabled instrument designed for use with the OPTIGEN Allergen-Specific IgE Assay in clinical laboratories for sample processing, measurement analyses, and reporting of OPTIGEN Allergen-Specific IgE Assay results. | 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, and Phadia 1000. 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.  |
|  Sample Processing | Fully automated | Same  |
|  Antibody Reagent | Enzyme-labeled goat anti-human IgE | Same  |
|  Testing Environment | Clinical laboratories | Same  |
|  Differences  |   |   |
| --- | --- | --- |
|  Item | New Device OPTIGEN AP 3600 Automated Instrument | Predicate Phadia ImmunoCAP  |
|  System Configuration | AP 3600 + pettes + consumables | Phadia 100, 250 or 1000 + ImmunoCAP Specific IgE reagents  |
|  Methodology | Chemiluminescence immunoassay | Fluoroenzyme immunoassay  |
|  Assay Format | Semi-quantitative | Quantitative  |
|  Sample Type | Serum | Serum and plasma (EDTA or sodium heparin)  |
|  Minimum Sample Volume | 600 μL | 40–200 μL  |
|  Processing/Temperature | 18–30°C | 37°C  |
|  Reagent Component | Fully integrated disposable pettes | Modular in concept and are available individually  |
|  Reported Unit | Luminometer Count (LMC) | kUA/L  |

{6}

|  Differences  |   |   |
| --- | --- | --- |
|  Item | New Device
OPTIGEN AP 3600 Automated Instrument | Predicate
Phadia ImmunoCAP  |
|  Reader | Included in AP 3600 | Phadia instruments  |
|  Class Allergy Scoring System | AP 3600 Class Allergy Scoring System of the OPTIGEN Allergen-Specific IgE Assay:
Class 0 to Class 6 | ASM (Alternate Scoring Method):
Class 0/1 to Class 6  |

I. Special Control/Guidance Document Referenced:

CLSI EP05-A3 — Evaluation of Precision Performance of Quantitative Measurement Procedures

CLSI EP6-A — Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline

CLSI EP17-A2 — Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline

J. Performance Characteristics:

1. Analytical Performance:

All results met the manufacturers pre-determined acceptance criteria.

a. Method comparison with predicate device:

A study was performed to compare results obtained with the OPTIGEN Universal Panel 20 using the AP 3600 Automated Instrument to the results obtained by the comparator method, Thermos Fisher ImmunoCAP Specific IgE. A total of 30–51 positive serum samples (with total IgE concentration ≥20 IU/mL) and 99–130 negative serum samples (with total IgE concentration &lt;20 IU/mL) were assayed in singleton by both methods. The samples tested (N) represent all AP 3600 classes, i.e. Class 0 to Class 6. The positive percentage agreement (PPA), negative percentage agreement (NPA), and total percentage agreement (TPA) for each allergen in the OPTIGEN Universal Panel 20 were calculated and are summarized in the table below:

{7}

|  OPTIGEN Universal Panel 20 |   |   | Positive Samples |   |   | Negative Samples |   |   | All Samples  |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  # | Allergen |   | N | PPA (%) | 95% CI | N | NPA (%) | 95% CI | N | TPA (%) | 95% CI  |
|  1 | Alternaria | m6 | 44 | 91.3 (42/46) | 79.7–96.6 | 109 | 99.1 (108/109) | 95.0–99.8 | 155 | 96.8 (150/155) | 92.7–98.6  |
|  2 | Aspergillus | m3 | 36 | 75.0 (27/36) | 58.9 –86.3 | 111 | 97.3 (108/111) | 92.4–99.1 | 147 | 91.8 (135/147) | 86.3–95.3  |
|  3 | Birch, White | t3 | 34 | 97.1 (33/34) | 85.1–99.5 | 101 | 99.0 (100/101) | 94.6–99.8 | 135 | 98.5 (133/135) | 94.8–99.6  |
|  4 | Cat | e1 | 51 | 96.1 (49/51) | 86.8–98.9 | 99 | 98.0 (97/99) | 92.9–99.4 | 150 | 97.3 (146/150) | 93.3–99.0  |
|  5 | Cladosporium | m2 | 41 | 73.2 (30/41) | 58.1–84.3 | 109 | 96.3 (105/109) | 90.9–98.6 | 150 | 90.0 (135/150) | 84.2–93.8  |
|  6 | Cockroach Mix | i6/i206 | 39 | 92.3 (36/39) | 79.7–97.4 | 104 | 96.2 (100/104) | 90.5–98.5 | 143 | 95.1 (136/143) | 90.2–97.6  |
|  7 | Codfish | f3 | 34 | 94.1 (32/34) | 80.9–98.4 | 115 | 96.5 (111/115) | 91.4–98.6 | 149 | 96.0 (111/149) | 91.5–98.1  |
|  8 | Dog | e5 | 51 | 94.1 (48/51) | 84.1–98.0 | 101 | 100.0 (101/101) | 96.3–100.0 | 152 | 98.0 (149/152) | 94.4–99.3  |
|  9 | Egg white | f1 | 34 | 94.1 (32/34) | 80.9–98.4 | 121 | 90.1 (109/121) | 83.5–94.2 | 155 | 91.0 (141/155) | 85.4–94.5  |
|  10 | Latex | k82 | 30 | 100 (30/30) | 88.7–100.0 | 105 | 91.4 (96/105) | 84.5–95.4 | 135 | 93.3 (96/135) | 87.8–96.5  |
|  11 | Milk | f2 | 33 | 90.9 (30/33) | 76.4–96.9 | 130 | 86.2 (112/130) | 79.2–91.1 | 163 | 87.1 (142/163) | 81.1–91.4  |
|  12 | Mite Farinae | d2 | 42 | 88.1 (37/42) | 75.0–94.8 | 104 | 96.2 (100/104) | 90.5–98.5 | 146 | 93.8 (137/146) | 88.7–96.7  |
|  13 | Mite Pteronyssinus | d1 | 42 | 95.2 (40/42) | 84.2–98.7 | 104 | 97.1 (101/104) | 91.9–99.0 | 146 | 96.6 (141/146) | 92.2–98.5  |
|  14 | Mugwort | w6 | 33 | 100 (33/33) | 89.6–100.0 | 101 | 98.0 (99/101) | 93.1–99.5 | 134 | 98.5 (99/143) | 94.7–99.6  |
|  15 | Peanut | f13 | 40 | 95.0 (38/40) | 83.5–98.6 | 100 | 97.1 (100/103) | 91.8–99.0 | 143 | 96.5 (138/143) | 92.1–98.5  |
|  16 | Ragweed mix I | w1/w3 | 32 | 93.8 (30/32) | 79.9–98.3 | 99 | 98.0 (97/99) | 92.9–99.4 | 131 | 96.9 (127/131) | 92.4–98.8  |
|  17 | Rice, Brown | f9 | 33 | 93.9 (31/33) | 80.4–98.3 | 102 | 99.0 (101/102) | 94.7–99.8 | 135 | 97.8 (132/135) | 93.7–99.2  |
|  17 | Soybean | f14 | 33 | 100 (33/33) | 89.6–100.0 | 111 | 94.6 (105/111) | 88.7–97.5 | 144 | 95.8 (105/144) | 91.2–98.1  |
|  18 | Timothy grass | g6 | 43 | 95.3 (41/43) | 84.5–98.7 | 103 | 94.2 (97/103) | 87.9–97.3 | 146 | 94.5 (138/146) | 89.6–97.2  |
|  20 | Wheat | f4 | 40 | 100 (40/40) | 91.2–100.0 | 103 | 93.2 (96/103) | 86.6–96.7 | 143 | 95.1 (136/143) | 90.2–97.6  |

The PPA, NPA and TPA for all allergens in the OPTIGEN Universal Panel 20 are summarized in the table below:

{8}

9

|   | Comparator Method  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Positive (Class 1 and above) | Negative (Class 0) | Total  |
|  OPTIGEN Universal Panel 20 on AP3600 | Positive (Class 1 and above) | 712 | 92 | 804  |
|   |  Negative (Class 0) | 55 | 2043 | 2098  |
|   |  Total | 767 | 2135 | 2902  |
|  PPA: 92.8% (712/767) 95% CI: 91.0 – 94.0%
NPA: 95.7% (2043/2135) 95% CI: 95.0 – 96.0%
TPA: 94.9% (2755/2902) 95% CI: 94.1 – 95.7%  |   |   |   |   |

A comparison by each AP 3600 class was also performed for all allergens and all serum samples tested by the two methods to determine the number of misclassifications. The results are summarized in the table below. For all AP 3600 classes, the total number of disagreements between the two methods is 582 or 20.1% (582/2902). The majority of disagreements (428/582 or 73.5%) were within one class. A total of 134 (134/582 or 23%) differed by two classes, 19 (19/582 or 3.2%) differed by three classes and one (1/582 or 0.17%) differed by four classes.

|   | Comparator Method  |   |   |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |   |  Class 0 | Class 1 | Class 2 | Class 3 | Class 4 | Class 5 | Class 6 | Total  |
|  OPTIGEN Universal Panel 20 on AP3600 | Class 0 | 2043 | 21 | 25 | 7 | 1 | 1 | 0 | 2098  |
|   |  Class 1 | 57 | 13 | 46 | 16 | 0 | 0 | 0 | 132  |
|   |  Class 2 | 27 | 28 | 116 | 91 | 9 | 0 | 0 | 271  |
|   |  Class 3 | 8 | 5 | 57 | 92 | 38 | 4 | 0 | 204  |
|   |  Class 4 | 0 | 0 | 5 | 30 | 17 | 8 | 3 | 63  |
|   |  Class 5 | 0 | 0 | 1 | 16 | 19 | 14 | 4 | 54  |
|   |  Class 6 | 0 | 0 | 1 | 1 | 24 | 29 | 25 | 80  |
|   |  Total | 2135 | 67 | 251 | 253 | 108 | 56 | 32 | 2902  |

A comparison between AP3600 and the comparator method for samples that differ by one AP 3600 class show strong correlation (84% and above) for all classes except Class 4 (68%). There is no risk of misclassification as these samples are all positive.

|   | OPTIGEN Universal Panel 20 on AP3600 vs. Comparator Method  |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- |
|   |  Positive (Class 1 and above)  |   |   |   |   |   |
|   |  Class 1 | Class 2 | Class 3 | Class 4 | Class 5 | Class 6  |
|  Within one class | 62/67 (92.5%) | 219/251 (87.3%) | 213/253 (84.2%) | 74/108 (68%) | 51/56 (91.1%) | 29/32 (90.6%)  |

The numbers of samples that differ by one AP 3600 class for each allergen tested are summarized in the table below.

{9}

10

|  OPTIGEN Universal Panel 20 on AP3600 vs. Comparator Method  |   |   |   |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  # | Allergen |   | N | Within one class | # | Allergen |   | N | Within one class  |
|  1 | Alternaria | m6 | 155 | 147 (95%) | 11 | Milk | f2 | 163 | 154 (94%)  |
|  2 | Aspergillus | m3 | 147 | 129 (88%) | 12 | Mite Farinae | d2 | 146 | 136 (93%)  |
|  3 | Birch, White | t3 | 135 | 131 (97%) | 13 | Mite Pteronyssinus | d1 | 146 | 137 (94%)  |
|  4 | Cat | e1 | 150 | 134 (89%) | 14 | Mugwort | w6 | 134 | 133 (99%)  |
|  5 | Cladosporium | m2 | 150 | 136 (91%) | 15 | Peanut | f13 | 143 | 137 (96%)  |
|  6 | Cockroach Mix | i6/i206 | 143 | 136 (95%) | 16 | Ragweed mix I | w1/w3 | 131 | 125 (95%)  |
|  7 | Codfish | f3 | 149 | 138 (93%) | 17 | Rice, Brown | f9 | 135 | 132 (98%)  |
|  8 | Dog | e5 | 152 | 150 (99%) | 18 | Soybean | f14 | 144 | 143 (99%)  |
|  9 | Egg white | f1 | 155 | 146 (94%) | 19 | Timothy grass | g6 | 146 | 133 (91%)  |
|  10 | Latex | k82 | 135 | 132 (98%) | 20 | Wheat | f4 | 143 | 139 (97%)  |

b. Precision/Reproducibility:

The precision of the OPTIGEN Universal Panel 20 on the AP 3600 Automated Instrument was assessed with 23 pooled serum samples according to CLSI guideline EP05-A3 in a study with a total of 40 runs, (two runs per day over the course of 20 days or eight runs per day for five days) or a total of 42 runs (three runs per day for 14 days), using one reagent lot and one instrument. Each sample was tested by one operator in two replicates per run giving a total of 80 or 84 replicates per test sample. The test samples represent all the AP 3600 Classes (Class 0 – Class 6) with the following ranges of values in LMC unit as summarized in the table below:

|  Classification Level of Samples in the Test Panel  |   |   |
| --- | --- | --- |
|  AP 3600 Class | Luminometer Count (LMC)  |   |
|   |  Lower Limit | Upper Limit  |
|  Class 0* | 250 | 500  |
|  Low Class 1* | 501 | 750  |
|  High Class 1# | 1000 | 1500  |
|  Class 2 | 1501 | 7000  |
|  Class 3 | 7001 | 36000  |
|  Class 4 | 36001 | 72000  |
|  Class 5 | 72001 | 150000  |
|  Class 6 | 150001 | 500000  |
|  *Class 0: Extends from 25% below cut-off to 50% below cut-off
*Low Class 1: Extends from 25% above cut-off to 50% above cut-off
#High Class 1: Extends from the midpoint of Class-1 (1000 LMC) to the upper limit of Class 1 (1500 LMC)  |   |   |

The SD and %CV for between-run, between-day, and total imprecision are calculated for each allergen at each Class level and the results are summarized in the tables below.

{10}

|  Between-Run  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  OPTIGEN Universal Panel 20 | AP 3600 Class  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|   |   |  Class 0 |   | Low Class 1 |   | High Class 1 |   | Class 2 |   | Class 3 |   | Class 4 |   | Class 5 |   | Class 6  |
|  # | Allergen | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD  |
|  1 | Alternaria | 132 | 28 | 139 | 17 | 238 | 18 | 471 | 16 | 5559 | 18 | 3714 | 10 | 8072 | 10 | n/a  |
|  2 | Aspergillus | 96 | 21 | 139 | 15 | 156 | 11 | 895 | 18 | 895 | 7 | 2053 | 5% | n/a | n/a | n/a  |
|  3 | Birch, White | 111 | 23 | 142 | 15 | 206 | 12 | 1389 | 27 | 1670 | 17 | 14983 | 23 | n/a | n/a | n/a  |
|  4 | Cat | 112 | 39 | 222 | 19 | 344 | 18 | 737 | 12 | 3000 | 12 | 5789 | 14 | 7685 | 11 | 17431  |
|  5 | Cladosporium | 60 | 21 | 89 | 16 | 209 | 11 | 497 | 9 | 1158 | 7 | n/a | n/a | n/a | n/a | n/a  |
|  6 | Cockroach Mix | 75 | 13 | 131 | 14 | 176 | 11 | 360 | 13 | 1413 | 14 | 3679 | 9 | n/a | n/a | 12400  |
|  7 | Codfish | 186 | 36 | 113 | 12 | 219 | 17 | 420 | 12 | 420 | 4 | 4245 | 11 | n/a | n/a | 16017  |
|  8 | Dog | 99 | 28 | 180 | 1 | 195 | 19 | 418 | 14 | 3107 | 13 | 5381 | 12 | 10749 | 9 | n/a  |
|  9 | Egg White | 71 | 22 | 120 | 20 | 260 | 12 | 476 | 15 | 476 | 5 | 4436 | 9 | 6669 | 6 | n/a  |
|  10 | Latex | 122 | 31 | 185 | 21 | 280 | 20 | 484 | 13 | 1478 | 10 | 7931 | 12 | n/a | n/a | 15102  |
|  11 | Milk | 65 | 19 | 83 | 13 | 180 | 14 | 468 | 11 | 468 | 2 | 4785 | 6 | 6283 | 6 | 6051  |
|  12 | Mite F | 114 | 35 | 123 | 16 | 203 | 14 | 276 | 11 | 276 | 3 | 6165 | 15 | 11396 | 11 | 18212  |
|  13 | Mite P | 112 | 23 | 87 | 13 | 163 | 10 | 233 | 13 | 233 | 1 | 2345 | 5 | 2836 | 4 | 18098  |
|  14 | Mugwort | 111 | 24 | 167 | 17 | 242 | 18 | 376 | 13 | 2002 | 20 | n/a | n/a | 7484 | 8 | 11048  |
|  15 | Peanut | 85 | 28 | 183 | 25 | 289 | 13 | 330 | 17 | 330 | 2 | 3249 | 8 | 9146 | 8 | 18409  |
|  16 | Ragweed Mix I | 147 | 31 | 189 | 26 | 448 | 25 | 1286 | 22 | 4388 | 22 | 11904 | 22 | n/a | n/a | n/a  |
|  17 | Rice, Brown | 67 | 23 | 258 | 28 | 236 | 18 | 671 | 18 | 1940 | 18 | 7320 | 19 | n/a | n/a | n/a  |
|  18 | Soybean | 107 | 32 | 127 | 12 | 117 | 8 | 257 | 9 | 658 | 6 | 2295 | 6 | n/a | n/a | n/a  |
|  19 | Timothy grass | 156 | 29 | 119 | 17 | 294 | 21 | 389 | 9 | 2441 | 9 | 8873 | 14 | 11273 | 13 | 15673  |
|  20 | Wheat | 87 | 20 | 131 | 10 | 275 | 19 | 408 | 8 | 408 | 4 | 4785 | 15 | 7164 | 6 | n/a  |
|  Between-Day  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  OPTIGEN Universal Panel 20 | AP 3600 Class  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|   |   |  Class 0 |   | Low Class 1 |   | High Class 1 |   | Class 2 |   | Class 3 |   | Class 4 |   | Class 5 |   | Class 6  |
|  # | Allergen | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD  |
|  1 | Alternaria | 53 | 11 | 87 | 11 | 76 | 6 | 235 | 8 | 1192 | 4 | 1937 | 5 | 878 | 1 | n/a  |
|  2 | Aspergillus | 56 | 12 | 129 | 14 | 161 | 11 | 489 | 10 | 489 | 4 | 1633 | 4 | n/a | n/a | n/a  |
|  3 | Birch, White | 47 | 10 | 154 | 16 | 375 | 23 | 834 | 16 | 0 | 0 | 12949 | 20 | n/a | n/a | n/a  |
|  4 | Cat | 105 | 37 | 126 | 11 | 358 | 18 | 297 | 5 | 0 | 0 | 2748 | 7 | 0 | 0 | 21415  |
|  5 | Cladosporium | 61 | 21 | 155 | 29 | 203 | 11 | 1626 | 28 | 1856 | 11 | n/a | n/a | n/a | n/a | n/a  |
|  6 | Cockroach Mix | 89 | 16 | 143 | 15 | 194 | 12 | 255 | 9 | 939 | 9 | 2143 | 5 | n/a | n/a | 10383  |
|  7 | Codfish | 46 | 9 | 150 | 16 | 220 | 17 | 346 | 10 | 346 | 3 | 3574 | 9 | n/a | n/a | 20664  |
|  8 | Dog | 75 | 22 | 41 | 4 | 155 | 15 | 181 | 6 | 3058 | 12 | 5394 | 12 | 12666 | 10 | n/a  |
|  9 | Egg White | 58 | 18 | 45 | 7 | 111 | 5 | 283 | 9 | 283 | 3 | 2195 | 5 | 7627 | 7 | n/a  |
|  10 | Latex | 109 | 27 | 28 | 3 | 153 | 11 | 385 | 11 | 917 | 6 | 2767 | 4 | n/a | n/a | 25639  |
|  11 | Milk | 66 | 20 | 106 | 17 | 292 | 23 | 396 | 9 | 396 | 2 | 3921 | 5 | 5546 | 5 | 9800  |
|  12 | Mite F | 76 | 23 | 116 | 15 | 315 | 21 | 420 | 16 | 420 | 5 | 5270 | 12 | 7049 | 7 | 15821  |
|  13 | Mite P | 116 | 24 | 142 | 22 | 62 | 4 | 348 | 19 | 348 | 2 | 3681 | 8 | 2156 | 3 | 24480  |
|  14 | Mugwort | 0 | 0 | 109 | 11 | 190 | 14 | 334 | 11 | 1007 | 10 | n/a | n/a | 0 | 0 | 10482  |
|  15 | Peanut | 82 | 27 | 126 | 17 | 418 | 19 | 38 | 2 | 38 | 0 | 2676 | 7 | 8341 | 7 | 19176  |
|  16 | Ragweed Mix I | 106 | 22 | 72 | 10 | 398 | 22 | 462 | 8 | 2636 | 13 | 0 | 0 | n/a | n/a | n/a  |
|  17 | Rice, Brown | 77 | 26 | 94 | 10 | 156 | 12 | 0 | 0 | 0 | 0 | 2782 | 7 | n/a | n/a | n/a  |
|  18 | Soybean | 71 | 21 | 90 | 8 | 157 | 11 | 269 | 9 | 615 | 6 | 825 | 2 | n/a | n/a | n/a  |

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12

|  Between-Day  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  OPTIGEN Universal Panel 20 | AP 3600 Class  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|   |   |  Class 0 |   | Low Class 1 |   | High Class 1 |   | Class 2 |   | Class 3 |   | Class 4 |   | Class 5 |   | Class 6  |   |
|  # | Allergen | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV  |
|  19 | Timothy grass | 96 | 18 | 94 | 13 | 0 | 0 | 433 | 10 | 2565 | 10 | 8721 | 14 | 4865 | 6 | 6551 | 3  |
|  20 | Wheat | 107 | 25 | 153 | 12 | 215 | 15 | 360 | 7 | 360 | 3 | 2026 | 6 | 8680 | 8 | n/a | n/a  |
|  Total Within-Laboratory Imprecision  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  OPTIGEN Universal Panel 20 | AP 3600 Class  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|   |   |  Class 0 |   | Low Class 1 |   | High Class 1 |   | Class 2 |   | Class 3 |   | Class 4 |   | Class 5 |   | Class 6  |   |
|  # | Allergen | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV  |
|  1 | Alternaria | 153 | 33 | 209 | 26 | 304 | 24 | 652 | 22 | 6186 | 20 | 4189 | 11 | 8797 | 11 | n/a | n/a  |
|  2 | Aspergillus | 120 | 26 | 211 | 22 | 290 | 21 | 1026 | 21 | 1026 | 8 | 2623 | 6 | n/a | n/a | n/a | n/a  |
|  3 | Birch, White | 141 | 30 | 275 | 29 | 575 | 35 | 1658 | 33 | 3679 | 38 | 20708 | 32 | n/a | n/a | n/a | n/a  |
|  4 | Cat | 157 | 55 | 263 | 23 | 516 | 26 | 1144 | 19 | 4633 | 18 | 8110 | 20 | 10277 | 14 | 27612 | 9  |
|  5 | Cladosporium | 107 | 37 | 208 | 39 | 375 | 20 | 1709 | 29 | 2352 | 13 | n/a | n/a | n/a | n/a | n/a | n/a  |
|  6 | Cockroach Mix | 136 | 24 | 227 | 24 | 285 | 17 | 598 | 22 | 1954 | 19 | 4492 | 11 | n/a | n/a | 21898 | 11  |
|  7 | Codfish | 191 | 37 | 207 | 23 | 318 | 25 | 812 | 23 | 812 | 7 | 6127 | 16 | n/a | n/a | 28606 | 11  |
|  8 | Dog | 130 | 37 | 258 | 25 | 309 | 31 | 619 | 21 | 4459 | 18 | 7848 | 17 | 20000 | 16 | n/a | n/a  |
|  9 | Egg White | 92 | 29 | 165 | 28 | 331 | 15 | 554 | 17 | 554 | 6 | 6209 | 13 | 10899 | 10 | n/a | n/a  |
|  10 | Latex | 164 | 41 | 233 | 27 | 336 | 24 | 740 | 20 | 3187 | 21 | 10264 | 16 | n/a | n/a | 30390 | 10  |
|  11 | Milk | 111 | 33 | 175 | 27 | 343 | 27 | 816 | 18 | 816 | 3 | 9034 | 12 | 10351 | 10 | 14115 | 7  |
|  12 | Mite F | 145 | 45 | 187 | 25 | 461 | 31 | 677 | 26 | 677 | 8 | 9362 | 22 | 16156 | 15 | 31416 | 9  |
|  13 | Mite P | 171 | 35 | 174 | 27 | 239 | 15 | 535 | 29 | 535 | 2 | 6122 | 14 | 5629 | 8 | 35038 | 8  |
|  14 | Mugwort | 131 | 28 | 243 | 24 | 400 | 29 | 503 | 17 | 2241 | 22 | n/a | n/a | 25927 | 26 | 17346 | 11  |
|  15 | Peanut | 128 | 42 | 240 | 33 | 646 | 29 | 546 | 28 | 546 | 4 | 6974 | 17 | 13267 | 11 | 31075 | 10  |
|  16 | Ragweed Mix I | 182 | 38 | 226 | 31 | 640 | 35 | 1641 | 28 | 7429 | 38 | 11997 | 23 | n/a | n/a | n/a | n/a  |
|  17 | Rice, Brown | 111 | 38 | 279 | 30 | 331 | 25 | 891 | 23 | 2300 | 22 | 7944 | 20 | n/a | n/a | n/a | n/a  |
|  18 | Soybean | 133 | 40 | 204 | 19 | 225 | 15 | 496 | 16 | 1102 | 10 | 3507 | 10 | n/a | n/a | n/a | n/a  |
|  19 | Timothy grass | 204 | 38 | 163 | 23 | 326 | 23 | 719 | 16 | 3641 | 14 | 18532 | 29 | 23382 | 28 | 26756 | 13  |
|  20 | Wheat | 160 | 37 | 231 | 18 | 420 | 28 | 711 | 13 | 711 | 7 | 5283 | 16 | 14183 | 13 | n/a | n/a  |

The %CV of the responses of all allergens tested was calculated for each class and summarized in the table below for each variance component evaluated:

|  Variance (%CV) | AP 3600 Class  |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- |
|   |  Class 0 | Class 1* | Class 2 | Class 3 | Class 4 | Class 5 | Class 6  |
|  Between-Run | 27 | 18 | 16 | 13 | 14 | 9 | 6  |
|  Between-Day | 20 | 15 | 13 | 8 | 10 | 7 | 7  |
|  Total | 36 | 26 | 24 | 19 | 20 | 16 | 10  |
|  *includes low and high  |   |   |   |   |   |   |   |

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# c. Linearity:

Five representative allergens of the OPTIGEN Universal Panel 20 were used to demonstrate linearity of the continuous LMC signal. A high-positive neat serum sample was diluted down across the lower end of the measuring range with a negative serum sample (&lt;LoD). The resulting 16 diluted samples were tested in triplicates with one lot of the OPTIGEN Universal Panel 20 using the AP 3600 Automated Instrument. Linear regression and polynomial analysis was performed according to CLSI guideline EP6-A. The results of the regression analysis and the claimed linear range for the allergens tested are summarized in the table below:

|  Allergen |   | Regression Equation | 95% CI Slope | 95% CI Intercept | r2 | Linear Range (LMC)  |
| --- | --- | --- | --- | --- | --- | --- |
|  Codfish | f 3 | y= 1.01x - 1105 | 0.95–1.07 | -8510–6301 | 0.99 | 77–298041  |
|  Mite Farinae | d2 | y= 1.07x + 6591 | 0.94–1.19 | -3858–17040 | 0.98 | 136–210488  |
|  Mite Pteronyssinus | d1 | y= 1.00x + 484 | 0.95–1.05 | -4665–5634 | 0.99 | 73–231799  |
|  Peanut | f13 | y= 1.04x + 15101 | 0.95–1.05 | -2803–33006 | 0.96 | 75–286476  |
|  Timothy grass | g6 | y= 1.02x + 2679 | 0.95–1.05 | -4971–10330 | 0.99 | 240–275740  |

# d. Carryover:

Not applicable

# e. Interfering Substances:

Refer to K051677

# 2. Other Supportive Instrument Performance Data Not Covered Above:

# Detection Limit:

The Limit of Blank (LoB) and Limit of Detection (LoD) were determined for the OPTIGEN Universal Panel 20 on the AP 3600 Automated Instrument. The methods used were in alignment with CLSI EP17-A2. The LoB is based on 75 blank measurements (one blank sample tested in 25 replicates  $\times$  one run/day  $\times$  three days) for each allergen for each of two reagent lots. The LoD for each allergen was determined by running four low level "Class 1" sera. Each serum was run in duplicates per run with two runs per day over four different days for each of two reagent lots. For each allergen, the criterion for use of a serum to calculate the LoB and LoD was that the mean LMC for the runs for that allergen had to be less than the cut-off between undetectable (Class 0: 0-500 LMC) and low positive (Class 1:501-1500 LMC). The results are summarized in the table below. Results showed that the LoB is above 0 LMC for six of the 20 allergens and that LoD is not uniform across allergens and instead was a range from 59 LMC to 241 LMC.

{13}

14

|  OPTIGEN Universal Panel 20 |   |   | LoB (LMC) | LoD (LMC)  |
| --- | --- | --- | --- | --- |
|  # | Allergen  |   |   |   |
|  1 | Birch, White | t3 | 71 | 148  |
|  2 | Ragweed mix I | w1/w3 | 0 | 113  |
|  3 | Timothy grass | g6 | 159 | 240  |
|  4 | Mugwort | w6 | 0 | 67  |
|  5 | Latex | k82 | 0 | 73  |
|  6 | Soybean | f14 | 0 | 64  |
|  7 | Rice, Brown | f9 | 0 | 74  |
|  8 | Codfish | f3 | 0 | 77  |
|  9 | Wheat | f4 | 16 | 94  |
|  10 | Peanut | f13 | 0 | 75  |
|  11 | Egg white | f1 | 0 | 68  |
|  12 | Milk | f2 | 175 | 241  |
|  13 | Aspergillus | m3 | 0 | 92  |
|  14 | Cladosporium | m2 | 0 | 81  |
|  15 | Alternaria | m6 | 0 | 59  |
|  16 | Dog | e5 | 63 | 137  |
|  17 | Cat | e1 | 0 | 84  |
|  18 | Cockroach Mix | i6/i206 | 0 | 66  |
|  19 | Mite Pteronyssinus | d1 | 0 | 73  |
|  20 | Mite Farinae | d2 | 45 | 136  |

Instrument-to-instrument variability:

To evaluate instrument-to-instrument variability, two pooled patient serum samples were tested in four replicates for five days using at least three OPTIGEN AP 3600 instruments. The % CV of the responses of all allergens tested was calculated for each class and summarized in the table below for each variance component evaluated:

|  Variance (%CV) | AP 3600™ Class  |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- |
|   |  Class 0 | Class 1 | Class 2 | Class 3 | Class 4 | Class 5 | Class 6  |
|  Between-Run | 19 | 20 | 14 | 15 | 13 | 9 | 7  |
|  Between-Day | 27 | 21 | 15 | 16 | 19 | 14 | 12  |
|  Between-Instrument | 22 | 11 | 7 | 1 | 2 | 5 | 2  |
|  Total | 39 | 32 | 23 | 23 | 24 | 18 | 14  |

K. Proposed Labeling:

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

{14}

L. Conclusion:

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

15

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHB/K182793](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DHB/K182793)

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