QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS

K113863 · Inova Diagnostics, Inc. · MST · Sep 20, 2012 · Immunology

Device Facts

• Record ID: K113863
• Device Name: QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS
• Applicant: Inova Diagnostics, Inc.
• Product Code: MST · Immunology
• Decision Date: Sep 20, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5750
• Device Class: Class 2

Intended Use

The QUANTA Flash™ DGP IgA is a chemiluminescent immunoassay for the semiquantitative determination of IgA antibodies to synthetic, deamidated gliadin peptides in human serum. The presence of IgA deamidated gliadin peptide antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of celiac disease and dermatitis herpetiformis. The QUANTA Flash™ DGP IgG is a chemiluminescent immunoassay for the semiquantitative detection of IgG antibodies to synthetic, deamidated gliadin peptides in human serum. The presence of IgG deamidated gliadin peptide antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of celiac disease in both IgA sufficient and IgA deficient subjects, as well as dermatitis herpetiformis. The QUANTA Flash™ DGP IgA Calibrators are intended for use with the QUANTA Flash™ DGP IgA chemiluminescent immunoassay to establish points of reference for the working curve that is used to determine Chemiluminescent Unit (CU) values in the measurement of IgA anti-DGP antibodies in serum. The QUANTA Flash™ DGP IgG Calibrators are intended for use with the QUANTA Flash™ DGP IgG chemiluminescent immunoassay to establish points of reference for the working curve that is used to determine Chemiluminescent Unit (CU) values in the measurement of IgG anti-DGP antibodies in serum. The QUANTA Flash DGP IgA Controls are intended for quality control purposes of the QUANTA Flash DGP IgA chemiluminescent immunoassay (CIA) kit run on the BIO FLASH ® Instrument that is used for the measurement of IgA anti-deamidated gliadin peptide (DGP) antibodies in human serum. The QUANTA Flash DGP IgG Controls are intended for quality control purposes of the QUANTA Flash DGP IgG chemiluminescent immunoassay (CIA) kit run on the BIO FLASH ® Instrument that is used for the measurement of IgG anti-deamidated gliadin peptide (DGP) antibodies in human serum.

Device Story

The QUANTA Flash DGP IgA/IgG assays are chemiluminescent immunoassays (CIA) performed on the BIO-FLASH instrument. Synthetic deamidated gliadin peptides (DGP) are coated onto paramagnetic beads. Patient serum is incubated with these beads; anti-DGP antibodies bind to the antigen. After washing, isoluminol-conjugated anti-human IgA or IgG is added. A luminescent reaction is triggered, and light (RLU) is measured by the BIO-FLASH optical system. RLU is proportional to the amount of bound antibody. The system uses a lot-specific Master Curve and two calibrators to generate a working curve for calculating Chemiluminescent Units (CU). The device is used in clinical laboratories by trained personnel. Results assist clinicians in diagnosing celiac disease and dermatitis herpetiformis, particularly in IgA-deficient patients for the IgG assay.

Clinical Evidence

Clinical validation included 499 samples for IgA and 484 for IgG, including celiac disease (CD), dermatitis herpetiformis (DH), and disease controls. For IgA: sensitivity 71.4%, specificity 100%. For IgG: sensitivity 89.2%, specificity 97.3%. ROC analysis showed AUC 0.94 (IgA) and 0.99 (IgG) for CD. Precision studies showed total CV <15%.

Technological Characteristics

Solid-phase heterogeneous chemiluminescent immunoassay; uses DGP-coated paramagnetic beads; isoluminol-labeled anti-human IgA/IgG conjugate; BIO-FLASH instrument system; semi-quantitative; lot-specific master curve stored in reagent barcode; 2-8°C storage; analytical measuring range 5.2-2,367.3 CU (IgA) and 2.8-1,936.7 CU (IgG).

Indications for Use

Indicated for the semi-quantitative determination of IgA and IgG antibodies to synthetic, deamidated gliadin peptides in human serum to aid in the diagnosis of celiac disease and dermatitis herpetiformis. IgG testing is indicated for both IgA-sufficient and IgA-deficient subjects.

Regulatory Classification

Identification

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

Special Controls

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

Predicate Devices

• QUANTA Lite™ Gliadin IgA II (k052143)
• QUANTA Lite™ Gliadin IgG II (k052142)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number:
k113863

B. Purpose for Submission:
New assay

C. Measurand:
IgG and IgA anti-deamidated gliadin peptide (DGP) antibodies

D. Type of Test:
Semi-quantitative chemiluminescent immunoassay

E. Applicant:
INOVA Diagnostics, Inc

F. Proprietary and Established Names:
QUANTA Flash™ DGP IgA
QUANTA Flash™ DGP IgG
QUANTA Flash™ DGP IgA Calibrators
QUANTA Flash™ DGP IgG Calibrators
QUANTA Flash™ DGP IgA Controls
QUANTA Flash™ DGP IgG Controls

G. Regulatory Information:

1. Regulation section:
21 CFR §866.5750 – Radioallergosorbent (RAST) Immunological Test System
21 CFR §862.1150 – Calibrator
21 CFR §862.1660 – Quality Control Material (Assayed and Unassayed)

2. Classification:
Class II (Assay and calibrator)
Class I (Control)

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3. Product code:
MST – Antibodies, Gliadin
JIX – Calibrator, Multi-Analyte Mixture
JJX – Single (Specified) Analyte Controls (Assayed and Unassayed)

4. Panel:
Immunology (82)
Clinical Chemistry (75)

H. Intended Use:

1. Intended use(s):

The QUANTA Flash™ DGP IgA is a chemiluminescent immunoassay for the semi-quantitative determination of IgA antibodies to synthetic, deamidated gliadin peptides in human serum. The presence of IgA deamidated gliadin peptides antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of celiac disease and dermatitis herpetiformis.

The QUANTA Flash™ DGP IgG is a chemiluminescent immunoassay for the semi-quantitative detection of IgG antibodies to synthetic, deamidated gliadin peptides in human serum. The presence of IgG deamidated gliadin peptide antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of celiac disease in both IgA sufficient and IgA deficient subjects, as well as dermatitis herpetiformis.

The QUANTA Flash™ DGP IgA Calibrators are intended for use with the QUANTA Flash™ DGP IgA chemiluminescent immunoassay to establish points of reference for the working curve that is used to determine Chemiluminescent Unit (CU) values in the measurement of IgA anti-DGP antibodies in serum.

The QUANTA Flash™ DGP IgG Calibrators are intended for use with the QUANTA Flash™ DGP IgG chemiluminescent immunoassay to establish points of reference for the working curve that is used to determine Chemiluminescent Unit (CU) values in the measurement of IgG anti-DGP antibodies in serum.

The QUANTA Flash DGP IgA Controls are intended for quality control purposes of the QUANTA Flash DGP IgA chemiluminescent immunoassay (CIA) kit run on the BIO FLASH ® Instrument that is used for the measurement of IgA anti-deamidated gliadin peptide (DGP) antibodies in human serum.

The QUANTA Flash DGP IgG Controls are intended for quality control purposes of the QUANTA Flash DGP IgG chemiluminescent immunoassay (CIA) kit run on the BIO FLASH ® Instrument that is used for the measurement of IgG anti-deamidated gliadin

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peptide (DGP) antibodies in human serum.

2. Indication(s) for use:
Same as Intended Use

3. Special conditions for use statement(s):
For prescription use only

4. Special instrument requirements:
BIO-FLASH™ Instrument System (k083518)

I. Device Description:

The QUANTA Flash™ DGP IgA and IgG reagent cartridges contain the following reagents:
- DGP coated paramagnetic beads in buffer, containing protein stabilizers and preservative.
- Assay buffer – containing Tris-buffered saline, Tween 20, protein stabilizers and preservatives.
- Tracer IgA or IgG – Isoluminol labeled anti-human IgA or IgG antibodies in buffer, containing protein stabilizers and preservative.

The QUANTA Flash™ DGP IgA or IgG Calibrators set includes two calibrators (Calibrator 1 and Calibrator 2). These are barcoded tubes containing 0.3 mL pre-diluted, ready-to-use reagent. Calibrators contain human IgA or human IgG antibodies to DGP in buffer. The calibration process utilizes the 2 calibrators included in the Calibrators set to adjust the predefined master curve into an instrument specific working curve. This working curve is used to calculate chemiluminescent unit (CU) values from the measured relative light units (RLU). The working curve is lot-specific, and is stored in the system for use with any reagent pack from that lot.

The QUANTA Flash™ DGP IgA or IgG Controls contain four vials (two each of Negative and Positive Controls) containing human antibodies to DGP in buffer, protein stabilizers and preservatives.

J. Substantial Equivalence Information:

1. Predicate device name(s) and Predicate 510(k) number(s):
QUANTA Lite™ Gliadin IgA II, k052143
QUANTA Lite™ Gliadin IgG II, k052142

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# 2. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device QUANTA Flash™ DGP IgA/IgG | Predicate QUANTA Lite™ Gliadin IgA/IgG II |
| Intended Use | Semi-quantitative determination of IgA/IgG antibodies to synthetic, deamidated gliadin peptides in human serum. | Same |
| Assay methodology | Solid phase (heterogeneous) immunoassay | Same |
| Antigen | Synthetic, deamidated gliadin peptides | Same |
| Assay Type | Semi-quantitative immunoassay | Same |
| Sample matrix | Serum | Same |
| Shelf life | One year | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device QUANTA Flash™ DGP IgA/IgG | Predicate QUANTA Lite™ Gliadin IgA/IgG II |
| Detection/ Operating principle | Chemiluminescent immunoassay (CIA) using paramagnetic microparticles (beads) | Enzyme-linked immunosorbent assay (ELISA) |
| Conjugate | Isoluminol conjugated anti-human IgA/IgG | Horse radish peroxidase (HRP)-conjugated goat anti-human IgA/IgG |
| Signal Detected | Luminescence (visible light) | Absorbance at 450nm |
| Calibration | Lot specific Master Curve + two calibrators (Sold separately) | Gliadin IgA/IgG II ELISA Low Positive and High Positive (Included in the kit) |

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

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

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

CLSI EP7-A2: Interference Testing in Clinical Chemistry; Approved Guideline – Second Edition

CLSI EP9-A2 IR: Method Comparison and Bias Estimation Using Patient samples; Approved Guideline – Second Edition (Interim Revision)

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

CLSI C28-A3c: Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline – Third Edition

L. Test Principle:

Anti-DGP antibodies present in the serum bind to DGP-coated paramagnetic beads during an incubation step. The unbound sample is washed away and isoluminol conjugated anti-human IgA (or IgG) antibody is added. After washing away any unbound conjugate, the remaining isoluminol conjugate bound to the DGP-coated paramagnetic beads is exposed to a catalyst and an oxidizing agent. The light produced from this reaction is measured as relative light units (RLU) by the BIO-FLASH optical system. The RLU are proportional to the amount of bound isoluminol conjugate, which in turn is proportional to the amount of anti-DGP antibodies bound to the DGP on the beads.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility studies:

i) Reproducibility: QUANTA Flash™ DGP IgA and IgG assays reproducibility testing was performed in accordance with CLSI EP5-A2 Guideline, at three different testing sites (one internal and two externals sites) using three specimens including one negative, one around-the-cutoff low positive and one medium positive. Samples were run in duplicates four times a day for 10 days, resulting in 80 individual data points. Two reagent lots, two calibrator lots and two operators were included as variables at the internal site. Total coefficient of variation (CV) was calculated based on within-run, between-run, between-reagent-lots, between-calibrator-lots, between-operators and between-sites precision.

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QUANTA Flash™ DGP IgA:

| Sample | Mean (CU) | Within Run CV% | Between Run CV% | Between Reagent Lots CV% | Between Calibrator Lots CV% | Between Operators CV% | Between Sites CV% | Total CV% |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 1 | 12.9 | 6.4 | 5.2 | 3.1 | 5.6 | 5.8 | 9.1 | 14.8 |
| 2 | 25.5 | 3.8 | 5.5 | 4.1 | 6.3 | 2.3 | 7.0 | 12.6 |
| 3 | 136.8 | 2.9 | 6.5 | 5.5 | 7.6 | 3.2 | 8.3 | 14.7 |

QUANTA Flash™ DGP IgG:

| Sample | Mean (CU) | Within Run CV% | Between Run CV% | Between Reagent Lots CV% | Between Calibrator Lots CV% | Between Operators CV% | Between Sites CV% | Total CV% |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 1 | 13.4 | 2.6 | 5.9 | 4.0 | 7.5 | 3.6 | 8.1 | 13.5 |
| 2 | 21.0 | 2.3 | 5.5 | 3.5 | 7.3 | 4.0 | 7.6 | 12.9 |
| 3 | 118.9 | 2.4 | 4.9 | 2.3 | 2.3 | 4.0 | 8.1 | 10.9 |

ii) Within-Laboratory Precision: The within laboratory precision of the QUANTA Flash™ DGP IgA and IgG assays was evaluated in accordance with CLSI EP5-A2 Guideline.

Eight samples each representing entire reportable range of DGP IgA or DGP IgG antibodies and with samples close to the cutoff were run in duplicates, twice a day, for at least 20 days resulting in $\geq 80$ individual data points. Data were analyzed and within-run, between-run, between-day and total precisions are summarized in the Table below.

QUANTA Flash™ DGP IgA:

| Sample | Mean (CU) | Within-Run CV% | Between-Run CV% | Between-Day CV% | Total CV% |
| --- | --- | --- | --- | --- | --- |
| 1 | 10.5 | 4.0% | 1.9% | 5.8% | 7.3% |
| 2 | 15.4 | 5.8% | 0.0% | 6.2% | 8.5% |
| 3 | 32.4 | 3.1% | 0.8% | 6.8% | 7.5% |
| 4 | 33.0 | 4.1% | 0.0% | 8.8% | 9.7% |
| 5 | 35.1 | 5.9% | 0.0% | 10.7% | 12.2% |
| 6 | 105.6 | 5.1% | 0.0% | 6.4% | 8.2% |
| 7 | 128.8 | 4.6% | 3.2% | 6.7% | 8.7% |
| 8 | 1930.8 | 4.9% | 3.3% | 7.8% | 9.8% |

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QUANTA Flash™ DGP IgG:

| Sample | Mean (CU) | Within-Run CV% | Between-Run CV% | Between-Day CV% | Total CV% |
| --- | --- | --- | --- | --- | --- |
| 1 | 5.8 | 3.1% | 2.5% | 2.0% | 4.5% |
| 2 | 16.8 | 3.0% | 0.5% | 1.5% | 3.3% |
| 3 | 20.7 | 2.5% | 1.3% | 2.2% | 3.6% |
| 4 | 24.6 | 1.9% | 1.8% | 1.5% | 3.0% |
| 5 | 85.1 | 2.2% | 0.9% | 2.9% | 3.8% |
| 6 | 411.6 | 1.9% | 1.6% | 2.3% | 3.4% |
| 7 | 791.0 | 3.1% | 2.0% | 0.7% | 3.8% |
| 8 | 1781.4 | 2.9% | 1.6% | 2.7% | 4.3% |

b. Linearity/assay reportable range:

i) Linearity: The QUANTA Flash™ DGP IgA and IgG assay linearity studies were evaluated in accordance with CLSI EP6-A Guideline. In each assay, six serum samples with various DGP IgA (or IgG) concentrations were diluted with a low negative serum to obtain values that cover the whole analytical measuring range (AMR). The observed values were graphed against the calculated values and linear regression was performed. The study results are summarized in the table below:

The QUANTA Flash™ DGP IgA:

| Sample | Test Range (CU) | Slope (95% CI) | Y-intercept (95% CI) | R² |
| --- | --- | --- | --- | --- |
| 1 | 5.2 to 34.0 | 1.00 (0.9 to 1.1) | 0.61 (-1.3 to 2.5) | 0.99 |
| 2 | 7.6 to 128.7 | 1.01 (1.0 to 1.0) | -0.17 (-2.3 to 2.0) | 1.00 |
| 3 | 5.2 to 356.5 | 1.02 (1.0 to 1.1) | 4.24 (-4.0 to 12.5) | 0.99 |
| 4 | 5.2 to 748.1 | 1.02 (1.0 to 1.0) | 3.32 (-2.1 to 8.7) | 1.00 |
| 5 | 96.7 to1990.4 | 1.02 (1.0 to 1.1) | 10.46 (-24.3 to 45.2) | 1.00 |
| 6 | 91.5 to 2596.8 | 0.96 (0.9 to 1.1) | -69.15 (-204.5 to 66.2) | 0.99 |

The claimed reportable Analytical Measuring range is 5.2 CU – 2,367.3 CU.

QUANTA Flash™ DGP IgG:

| Sample | Test Range (CU) | Slope (95% CI) | Y-intercept (95% CI) | R² |
| --- | --- | --- | --- | --- |
| 1 | 1.9 to 36 | 1.06 (1.0 to 1.1) | -2.37 (-3.1 to -1.7) | 1.00 |
| 2 | 6.8 to 81.9 | 0.97 (0.9 to 1.0) | 0.04 (-2.0 to 2.1) | 0.99 |
| 3 | 18.6 to 173.6 | 1.04 (1.0 to 1.1) | 5.46 (-1.1 to 12.0) | 0.99 |
| 4 | 39.6 to 449.8 | 0.94 (0.9 to 1.0) | -2.06 (-16.0 to 11.9) | 0.99 |
| 5 | 213.2 to 1,668 | 0.95 (0.9 to 1.0) | 101.97 (72.2 to 131.7) | 1.00 |
| 6 | 255.8 to 2,565.4 | 0.99 (0.9 to 1.0) | 79.28 (-4.0 to 162.6) | 0.99 |

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The claimed reportable Analytical Measuring range is 2.8 CU – 1,936.7 CU.

ii) **Dilution Recovery**: The BIO-FLASH software has an Auto-rerun option available. If this option is selected, the instrument will automatically rerun any sample that has a result &gt;2,367.3 CU for DGP IgA or &gt;1,936.7 CU for DGP IgG, by further diluting it by a factor of 10, and calculating the actual CU using this additional dilution factor.

To confirm the Auto-rerun function, two high positive specimens with results above the analytical measuring range were selected for each assay. The samples were run with the Auto-rerun function enabled on the BIO-FLASH. Then the specimens were manually diluted the same way as it happens in the Auto-rerun function (10 fold dilution), and tested on the BIO-FLASH. The results were within the analytical measuring range after auto-rerun or manual dilution for all specimens. The differences between the manual and automatic results for DGP IgA were 11% and 15%, and for the DGP IgG 19% and 5%.

iii) **High Concentration Hook-effect**: To assess hook effect, the measurement signal (i.e., RLU) was examined for high positive specimens with results above the analytical measuring range before and after automatic or manual dilution. All sera produced significantly higher RLU values when used "as is" compared to the manually or automatically diluted ones, thereby confirming that high positive specimens above the analytical measuring range do not show hook effect up to 5167.2 CU in the DGP IgA assay and up to 4323.7 CU in the DGP IgG assay.

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

i) **Traceability**: There is currently no recognized international standard for the measurement of IgA or IgG anti-deamidated gliadin peptide antibodies. Calibrators are assigned values based on a 20 unit cutoff between positive and negative during assay development.

ii) **Calibrator and controls**:

**Calibrators**: The QUANTA Flash™ DGP IgA (or IgG) chemiluminescent immunoassay utilizes predefined lot specific master curve that is stored in the reagent cartridge barcode. The QUANTA Flash™ DGP IgA (or IgG) Calibrators are designed to produce an instrument specific working curve from the parameters of the master curve, with a decision point based on the performance characteristics and clinical evaluation of the QUANTA Flash™ DGP IgA (or IgG) assay. Calibrators are tested on multiple instruments with multiple lots of reagents prior to value assignment.

Stability studies demonstrated that both the QUANTA Flash™ DGP IgA and IgG Calibrators can be used for up to 4 calibrations over an 8 hour period.

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Controls: The QUANTA Flash™ DGP IgA (or IgG) Controls are made up of a Negative Control and a Positive Control. Each contains a different amount of IgA (or IgG) anti-DGP antibodies. The Negative Control is designed to assess precision and accuracy of the assay at very low antibody levels. The Positive Control is designed to assess precision and accuracy of the assay at moderate to high antibody levels.

Stability studies demonstrated that opened Controls can be used for up to 15 times, with a maximum time of 10 minutes onboard the instrument per use. The total time the control tubes can be uncapped onboard the instrument is $2\frac{1}{2}$ hours, or 10 minutes per use.

iii) Kit Stability: Stability studies support that the QUANTA Flash™ DGP IgA reagent cartridge in-use (on-board) stability is 40 days, and the QUANTA Flash™ DGP IgG reagent cartridge in-use (on-board) stability is 62 days. Accelerated stability studies also support that the QUANTA Flash™ DGP IgA and IgG assays, as well as the Calibrators and Controls have a shelf life of one year at $2-8^{\circ}\mathrm{C}$.

d. Detection limit:

QUANTA Flash™ DGP IgA: The Limit of Detection (LoD) of the QUANTA Flash™ DGP IgA assay is 730.3 RLU or 1.826 chemiluminescent unit (CU), which is below the analytical measuring range of the assay. It was determined consistent with CLSI EP17-A guideline with proportions of false positives (alpha) less than $5\%$ and false negatives (beta) less than $5\%$; based on 140 determinations, with 60 blank and 80 low level samples. The LoB is 504.9 RLU or 1.262 CU.

QUANTA Flash™ DGP IgG: The Limit of Detection (LoD) of the QUANTA Flash™ DGP IgG assay is 469.2 RLU or 0.626 CU, which is below the analytical measuring range of the assay. It was determined consistent with CLSI EP17-A guideline with proportions of false positives (alpha) less than $5\%$ and false negatives (beta) less than $5\%$; based on 140 determinations, with 60 blank and 80 low level samples. The LoB is 257.7 RLU or 0.344 CU.

e. Analytical specificity:

i) Cross-reactivity:

QUANTA Flash™ DGP IgA: To test potential cross-reactivity with autoantibodies and infection-induced antibodies, 201 patient samples were tested from patients with infectious diseases, autoimmune diseases and connective tissue diseases, including those characterized with gastrointestinal symptoms. None of those specimens were positive in the QUANTA Flash™ DGP IgA test.

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QUANTA Flash™ DGP IgG: To test potential cross-reactivity with autoantibodies and infection-induced antibodies, 185 patient samples were tested from patients with infectious diseases, autoimmune diseases and connective tissue diseases, including those characterized with gastrointestinal symptoms. Two out of the 31 viral hepatitis specimens, two out of the 17 H. pylori infection specimens, and one out of the 37 rheumatoid arthritis specimens were positive with the QUANTA Flash™ DGP IgG assay. Altogether, only five out of the 185 specimens (3%) were positive, indicating the minimal cross-reactivity.

ii) Interference: The interference study was performed according to CLSI EP07-A2 Guideline.

QUANTA Flash™ DGP IgA: Three specimens, including one negative (5.8 CU), one around-the-cutoff low positive (24.7 CU) and one medium positive (186.9 CU), were tested. Interfering substances were spiked into every specimen at three different concentrations in 10% of total specimen volume, and the resulting samples were analyzed in triplicates with the DGP IgA assay. Recovery of the unit values was calculated compared to control samples spiked with the same volume of diluents. No interference was detected with bilirubin up to 10 mg/dL, hemoglobin up to 200 mg/dL, triglycerides up to 1,000 mg/dL, cholesterol up to 224.3 mg/dL and with rheumatoid factor IgM up to 500 IU/mL.

QUANTA Flash™ DGP IgG: Four specimens, including one negative (12.8 CU), two around-the-cutoff low positive (32 and 41.3 CU) and one medium positive (139.8 CU), were tested. Interfering substances were spiked into every specimen at three different concentrations in 10% of total specimen volume, and the resulting samples were analyzed in triplicates with the QUANTA Flash™ DGP IgG assay. Recovery of the unit values was calculated compared to control samples spiked with the same volume of diluents. No interference was detected with bilirubin up to 10 mg/dL, hemoglobin up to 200 mg/dL, triglycerides up to 1000 mg/dL or cholesterol up to 224.3 mg/dL and rheumatoid factor IgM up to 500 IU/mL.

f. Assay cut-off: The cut off was established in accordance to CLSI C28-A3c Guideline.

QUANTA Flash™ DGP IgA: The assay cutoff of 20 CU was determined by testing 355 serum samples from control population including 201 healthy subjects.

QUANTA Flash™ DGP IgG: The assay cutoff of 20 CU was determined by testing 292 serum samples from control population including 201 healthy subjects.

2. Comparison studies:

a. Method comparison with predicate device:

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QUANTA Flash™ DGP IgA: One hundred and two samples within the reportable range of the assay were tested with the QUANTA Flash™ DGP IgA assay and the predicate method. The samples were collected from normal subjects, diagnosed celiac (CD) patients, and patients with other defined diseases non-CD and dermatitis herpetiformis (DH) patients. These samples were tested on both the QUANTA Flash™ DGP IgA CIA and on the predicate ELISA. The study results are summarized in the table below.

| | QUANTA Lite™ Gliadin IgA II | | | |
| --- | --- | --- | --- | --- |
| | | Positive | Negative | Total |
| QUANTA Flash™ DGP IgA | Positive | 65 | 3* | 68 |
| | Negative | 6** | 28 | 34 |
| | Total | 71 | 31 | 102 |

(*) Two patients were suspected CD with no diagnosis, while the third was a DH patient. (**) Two patients had DH. Three patients had CD, two without clinical presentation, one with a Marsh III biopsy. The last patient had ulcerative colitis

Positive Agreement = 91.5% (95% C.I. = 82.5 - 96.8%)

Neg. Agreement = 90.3% (95% C.I. = 74.2 - 98.0%)

Overall Agreement = 91.2% (95% C.I. = 83.9 - 95.9%)

In separate analyses, 21 samples from patients with DH were compared to the predicate. The study results are summarized in the tables below.

| | QUANTA Lite™ Gliadin IgA II | | | |
| --- | --- | --- | --- | --- |
| | | Positive | Negative | Total |
| QUANTA Flash™ DGP IgA | Positive | 12 | 1 | 13 |
| | Negative | 2 | 6 | 8 |
| | Total | 14 | 7 | 21 |

Positive Agreement = 85.7% (95% C.I. = 57.2% - 98.2%)

Negative Agreement = 85.7% (95% C.I. = 42.1 - 99.6%)

Overall Agreement = 85.7% (95% C.I. = 63.7% - 97.0%)

QUANTA Flash™ DGP IgG: Two hundred and forty one samples within the reportable range of the assay were tested with the QUANTA Flash™ DGP IgG assay and the predicate method.

The samples were collected from normal subjects, diagnosed celiac (CD) patients, and patients with other defined diseases non-CD and DH patients. These samples were tested on both the QUANTA Flash™ DGP IgG CIA and on the predicate ELISA. The study results are summarized in the table below.

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| | QUANTA Lite™ Gliadin IgG II | | | |
| --- | --- | --- | --- | --- |
| | | Positive | Negative | Total |
| QUANTA Flash™ DGP IgG | Positive | 78 | 26* | 104 |
| | Negative | 4** | 133 | 137 |
| | Total | 82 | 159 | 241 |

(*) Thirteen samples were from CD patients; three being on gluten-free diet. One sample was from a suspected CD patient that is IgA anti-DGP positive. Two samples had H. pylori gastritis, two had viral hepatitis, and one had rheumatoid arthritis. One patient, with low blood count, was IgG anti-h-tTG positive. The remaining 6 samples were from apparently healthy individuals; one had gastrointestinal symptoms at time of sample collection, with two being IgA anti-h-tTG positive. (**) Three samples were from CD patients, and one was from a DH patient.

Positive Agreement = 95.1% (95% C.I. = 88.0 - 98.7%)

Negative Agreement = 83.6% (95% C.I. = 77.0 - 89.0%)

Overall Agreement = 87.6% (95% C.I. = 82.7 - 91.4%)

In separate analyses, the results of thirteen IgA deficient samples from patients with diagnosed celiac disease were compared to the predicate, and 23 samples from patients with DH were compared to the predicate. The study results are summarized in the tables below.

IgA Deficient Celiac Disease:

| | QUANTA Lite™ Gliadin IgG II | | | |
| --- | --- | --- | --- | --- |
| | | Positive | Negative | Total |
| QUANTA Flash™ DGP IgG | Positive | 5 | 2 | 7 |
| | Negative | 2 | 4 | 6 |
| | Total | 7 | 6 | 13 |

Positive Agreement = 71.4% (95% C.I. = 29.0% - 96.3%)

Negative Agreement = 66.7% (95% C.I. = 22.3% - 95.7%)

Overall Agreement = 69.2% (95% C.I. = 38.6% - 90.9%)

Dermatitis Herpetiformis:

| | QUANTA Lite™ Gliadin IgG II | | | |
| --- | --- | --- | --- | --- |
| | | Positive | Negative | Total |
| QUANTA Flash™ DGP IgG | Positive | 16 | 0 | 16 |
| | Negative | 2 | 5 | 7 |
| | Total | 18 | 5 | 23 |

Positive Agreement = 88.9% (95% C.I. = 65.3% - 98.6%)

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Negative Agreement $= 100.0\%$ (95% C.I. $= 47.8\% -100.0\%$

Overall Agreement $= 91.3\%$ (95% C.I. $= 72.0\% - 98.9\%$ )

b. Matrix comparison:

Not applicable.

# 3. Clinical studies:

# a. Clinical Sensitivity and Specificity:

QUANTA Flash™ DGP IgA: The clinical validation study included 54 CD samples (39 samples from patients with CD but on gluten free diet or with unconfirmed CD), 103 non-celiac disease controls, and 21 samples from patients with DH. A separate external study included 93 CD samples, 151 samples from individuals seeking medical attention in whom CD was excluded based on physical exam and diagnostic tests, and 98 disease controls. The results were analyzed to calculate sensitivity and specificity for CD $(n = 147)$ and DH $(n = 21)$ separately using the same control population $(n = 352)$ . The results of this testing are shown in the Tables below:

Clinical sensitivity and specificity of the QUANTA Flash™ DGP IgA assay in CD (total population):

| | Diagnosis | | | |
| --- | --- | --- | --- | --- |
| | | CD | Not CD | Total |
| QUANTA Flash™ DGP IgA | Positive | 105 | 0 | 105 |
| | Negative | 42 | 352 | 394 |
| | Total | 147 | 352 | 499 |

Sensitivity $= 71.4\%$ (95% C.I. $= 63.4 - 78.6\%$

Specificity $= 100.0\%$ (95% C.I. $= 99.0 - 100\%$

The distribution and positivity rate in the disease control population:

| Patient Group | N | # of positives |
| --- | --- | --- |
| Autoimmune liver disease | 5 | 0 |
| Viral hepatitis | 47 | 0 |
| Inflammatory bowel disease (Crohn's Disease and Ulcerative Colitis) | 17 | 0 |
| H. pylori infection | 17 | 0 |
| Food allergy | 9 | 0 |
| Systemic rheumatic disease | 12 | 0 |
| Autoimmune thyroid disease | 22 | 0 |
| Patients with gastrointestinal symptoms | 11 | 0 |
| Type 1 diabetes mellitus | 14 | 0 |

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Diagnostic sensitivity and specificity were calculated on the DH group separately, and the results are shown in the Table below.

Clinical sensitivity and specificity of the QUANTA Flash™ DGP IgA assay in DH:

| | Diagnosis | | | |
| --- | --- | --- | --- | --- |
| | | DH | Not DH | Total |
| QUANTA Flash™ DGP IgA | Positive | 13 | 0 | 13 |
| | Negative | 8 | 352 | 360 |
| | Total | 21 | 352 | 373 |

Sensitivity $= 61.9\%$ (95% C.I. = 38.4 - 81.9%)

Specificity $= 100.0\%$ (95% C.I. = 99.0 - 100%)

QUANTA Flash™ DGP IgG: The clinical validation study included 62 CD samples from INOVA's serum library (including 7 with selective IgA deficiency), 87 non-celiac disease controls, 39 samples from patients with CD but on gluten free diet or with unconfirmed CD, and 23 samples from patients with DH. A separate external study included 102 CD samples (including 9 with selective IgA deficiency), 151 samples from individuals seeking medical attention in whom CD was excluded after physical exam and diagnostic tests, and 98 disease controls. The results were analyzed to calculate sensitivity and specificity for CD $(n = 148)$ and DH $(n = 23)$ separately using the same control population $(n = 336)$ .

Clinical sensitivity and specificity of the QUANTA Flash™ DGP IgG assay in CD (total population):

| | Diagnosis | | | |
| --- | --- | --- | --- | --- |
| | | CD | Not CD | Total |
| QUANTA Flash™ DGP IgG | Positive | 132 | 9* | 141 |
| | Negative | 16 | 327 | 343 |
| | Total | 148 | 336 | 484 |

(*) Two samples had H. pylori gastritis, two had viral hepatitis, and one had rheumatoid arthritis.

Sensitivity $= 89.2\%$ (95% C.I. = 83.0 - 93.7%)

Specificity $= 97.3\%$ (95% C.I. = 95.0 - 98.8%)

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The distribution and positivity rate in the disease control population:

| Patient Group | n | # of positives |
| --- | --- | --- |
| Autoimmune liver disease | 5 | 0 |
| Viral hepatitis | 31 | 2 |
| Inflammatory bowel disease (Crohn's Disease and Ulcerative Colitis) | 17 | 0 |
| H pylori infection | 17 | 2 |
| Food allergy | 9 | 0 |
| Systemic rheumatic disease | 12 | 0 |
| Autoimmune thyroid disease | 22 | 0 |
| Patients with gastrointestinal symptoms | 11 | 0 |
| Type 1 diabetes mellitus | 14 | 0 |
| Rheumatoid arthritis | 37 | 1 |
| Other infectious disease (HIV, Syphilis) | 10 | 0 |
| Total | 185 | 5 |

Altogether 16 samples were from IgA deficient CD patients. Nine out of 16 (56.3%) were positive with the QUANTA Flash™ DGP IgG assay, indicating that the assay is a useful tool for CD screening in IgA deficient subjects.

Clinical sensitivity and specificity of the QUANTA Flash™ DGP IgG assay in IgA deficient CD:

| | Diagnosis | | | |
| --- | --- | --- | --- | --- |
| | | CD (IgA deficient) | Not CD | Total |
| QUANTA Flash™ DGP IgG | Positive | 9 | 9 | 18 |
| | Negative | 7 | 327 | 334 |
| | Total | 16 | 336 | 352 |

Sensitivity $= 56.3\%$ (95% C.I. = 29.9 - 80.2%)

Specificity $= 97.3\%$ (95% C.I. = 95.0 - 98.8%)

Diagnostic sensitivity and specificity were calculated on the DH group separately, and the results are shown in the Table below.

Clinical sensitivity and specificity of the QUANTA Flash™ DGP IgG assay in DH:

| | Diagnosis | | | |
| --- | --- | --- | --- | --- |
| | | DH | Not DH | Total |
| QUANTA Flash™ DGP IgG | Positive | 16 | 9* | 25 |
| | Negative | 7 | 327 | 334 |
| | Total | 23 | 336 | 359 |

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(*)Two samples have H. pylori gastritis, two have viral hepatitis, and one has rheumatoid arthritis.

Sensitivity = 69.6% (95% C.I. = 47.1 – 86.8%)

Specificity = 97.3% (95% C.I. = 95.0 – 98.8%)

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

Not applicable

4. Clinical cut-off:

See Assay Cutoff above.

5. Expected values/Reference range:

QUANTA Flash™ DGP IgA: The expected result in the normal population is “negative”. The prevalence of CD in the not-at-risk reference population is close to 1%, so occasional positive results can be expected when healthy subjects are tested. A study of 232 apparently healthy individuals tested with the QUANTA Flash™ DGP IgA assay showed that ~1% were positive (one positive and one weak positive).

QUANTA Flash™ DGP IgG: The expected result in the normal population is “negative”. The prevalence of CD in the not-at-risk reference population is close to 1%, so occasional positive results can be expected when healthy subjects are tested. A study of 232 apparently healthy individuals tested with the QUANTA Flash DGP™ IgG assay showed that ~2% were positive (four positive and one weak positive).

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.

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