← Product Code [MST](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/MST) · K132082

# AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK (K132082)

_Aesku Diagnostics · MST · Dec 5, 2013 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/MST/K132082

## Device Facts

- **Applicant:** Aesku Diagnostics
- **Product Code:** [MST](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/MST.md)
- **Decision Date:** Dec 5, 2013
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5750
- **Device Class:** Class 2
- **Review Panel:** Immunology

## Intended Use

AESKULISA DGP-Check is an in-vitro diagnostic device This solid phase enzyme immunassay employs synthetic, deemicated gliadin-derived pertides for the combined seniqualitative detation of 194 and 195 and 195 and 195 and its deamical desirical d Gliadin-specific peptides (DGP) in human serum. The assay is an aid in the diac disease (gluter-sensitive enteropatiy) and should be used in conjunction with ather serological tests and clinical findings. AESKULISA DGP-G is an in-vitro diagnostic device This salid phase enzyme immuncessay employs synthetic, deamicated gliadin-derived peptides for the semiquantitative and qualitative detection of IgG antibodies against deamidded Gliadin-specific peptides (DGP) in human serum. The assy is an aid in the diegnosis of celies disease (gluter-sensitive enteropedly) and should be used in conjunction with other serological tests and clinical findings. AESKULISA DGP-A is an in-vitro diagnostic device. This solid phase enzyme immunossay employs synthetic, deamidated gliadin-derived peptides for the semiqualitative and qualitative detection of 1gA antibodies against deaminded Gliadin-specific peptides (DGP) in human serum. The assay is an aid in the diagnosis of cellac disease (gluter-sensitive enteropathy) and should be used in corjunction with other serological tests and clinical findings.

## Device Story

AESKULISA DGP-A, DGP-G, and DGP-Check are solid-phase indirect noncompetitive enzyme immunoassays (ELISA) used to detect antibodies against deamidated gliadin-derived peptides (DGP) in human serum. The device utilizes 96-well microtiter plates coated with synthetic deamidated gliadin peptides. Patient serum is diluted 1:100 and added to the wells; specific antibodies bind to the immobilized antigen. A goat anti-human IgA/IgG-HRP conjugate is added, followed by a TMB chromogenic substrate. The resulting color intensity, measured via spectrophotometric microtiter plate reader at 450 nm, is proportional to the antibody concentration. The assay is performed in a clinical laboratory setting. Results are interpreted semiquantitatively against a 6-point calibrator curve (0-300 U/mL) or qualitatively using a cut-off calibrator. The output assists clinicians in diagnosing celiac disease when used alongside other serological tests and clinical findings.

## Clinical Evidence

No clinical data provided in the document.

## Technological Characteristics

Solid-phase indirect noncompetitive enzyme immunoassay. Components: 96-well microtiter plates coated with synthetic deamidated gliadin peptides, HRP-conjugated goat anti-human IgA/IgG, TMB substrate, and 1M HCl stop solution. Requires spectrophotometric microtiter plate reader (450 nm). Quantitative/semi-quantitative output via 4-parameter Lin-Log fit. Standardized via internal lot-to-lot comparison (no international standards).

## 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 SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:
k132082

B. Purpose for Submission:
New device

C. Measurand:
Anti-Deaminated Gliadin-derived Peptide (DGP) Antibodies

D. Type of Test:
Semi-quantitative and qualitative enzyme immunoassay

E. Applicant:
AESKU Diagnostics GmbH & Co.KG

F. Proprietary and Established Names:
AESKULISA® DGP-A
AESKULISA® DGP-G
AESKULISA® DGP-Check

G. Regulatory Information:
1. Regulation section:
21 § CFR 866.5750 – Radioallergosorbent (RAST) immunological test system
2. Classification:
Class II
3. Product code:
MST – Antibodies Gliadin
4. Panel:
Immunology (82)

H. Intended Use:
1. Intended use(s):
AESKULISA DGP-A is an in vitro diagnostic device. This solid phase enzyme immunoassay

{1}

employs synthetic, deamidated gliadin-derived peptides for the semiquantitative and qualitative detection of IgA antibodies against deamidated Gliadin-specific peptides (DGP) in human serum. The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjunction with other serological tests and clinical findings.

AESKULISA DGP-G is an in vitro diagnostic device. This solid phase enzyme immunoassay employs synthetic, deamidated gliadin-derived peptides for the semiquantitative and qualitative detection of IgG antibodies against deamidated Gliadin-specific peptides (DGP) in human serum. The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjunction with other serological tests and clinical findings.

AESKULISA DGP-Check is an in vitro diagnostic device. This solid phase enzyme immunoassay employs synthetic, deamidated gliadin-derived peptides for the combined semiquantitative and qualitative detection of IgA and IgG antibodies against deamidated Gliadin-specific peptides (DGP) in human serum. The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjunction with other serological tests and clinical findings.

2. Indication(s) for use:
Same as intended use

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

4. Special instrument requirements:
Microplate reader capable of reading absorbance values at 450 nm

I. Device Description:

AESKULISA DGP kits include the following common reagents:
- Sample buffer concentrate (5x), 1x20 mL
- Wash buffer concentrate (50x), 1x20 mL
- Negative/positive/control, containing human serum, BSA and buffer components, 1x1.5mL each
- Cut-off calibrator for qualitative analysis, containing human serum, BSA and buffer components, 1x1.5mL
- Calibrators, (0, 3, 10, 30, 100; 300 U/mL), containing human serum, BSA and buffer components, 6x1.5mL
- Conjugate IgA/IgG – Goat Anti-human Immunoglobulins conjugated to horseradish peroxidase (HRP), 1x15mL
- TMB Substrate - Tetramethylbenzidine (TMB) chromogenic substrate, 1x15 mL
- Stop solution containing 1 M HCl, 1x15mL
- 96-well microtiter plate (12x8 well strips) with breakaway microwell coated with synthetic deaminated gliadin peptides.

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J. Substantial Equivalence Information:

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

QUANTA Lite™ Gliadin IgA II (k052143)
QUANTA Lite™ Gliadin IgG II (k052142)
QUANTA Lite™ Celiac DGP Screen (k062708)

2. Comparison with predicates:

|  Similarities  |   |   |
| --- | --- | --- |
|  Feature | New devices
AESKULISA
DGP-A/G/Check | Predicate device
INOVA QUANTA Lite Gliadin
IgA II/ IgG II/
Celiac DPG Screen  |
|  Indications for Use | Aid in the diagnosis of celiac disease and should be used in conjunction with other serological tests and clinical findings | Same  |
|  Antigen | Deaminated gliadin peptides | Same  |
|  Conjugate | HRP conjugated goat anti-human IgA, IgG or IgA/IgG immunoglobulins | Same  |
|  Assay Principle | Indirect noncompetitive enzyme immunoassay | Same  |
|  Sample Dilution | 1:100 | Same  |
|  Specimen Type | Serum | Same  |
|  Assay Platform | 96 well microtiter plates | Same  |
|  Incubation times | 30-30-30 minutes | Same  |
|  Signal detected | Absorbance/optical density (OD) at 450 nm | Same  |
|  Differences  |   |   |
| --- | --- | --- |
|  Feature | New devices | Predicate devices  |
|  Antigen used | Synthetic, deaminated gliadin peptide | Purified gliadin peptides  |
|  Calibrators | 6 calibrators: 0; 3; 10; 30; 100; 300 (U/mL)
1 cut-off calibrator | None  |
|  Controls | Positive Control | Low Positive Control
High Positive Control  |
|  Assay Cut-off
DGP-A & DGP-G
DGP-Check | 12-18 U/mL equi zone
16-24 U/mL equi zone | 20 U/mL
20 U/mL  |

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|  Differences  |   |   |
| --- | --- | --- |
|  Feature | New devices | Predicate devices  |
|  Result Interpretation Qualitative | Based on the cutoff calibrator
Negative: < 0.8xOD cutoff
Equivocal: 0.8xOD cut-off
≤OD patient ≤ 1.2 x OD cut-off
Positive: > 1.2 x OD cutoff | No qualitative interpretation  |
|  Semi-quantitative: IgA or IgG | ≤12 U/mL= Negative
12-18 U/mL=Equivocal
>18 U/mL=Positive | ≤20 U/mL= Negative
20-30 U/mL=Weak Positive
>30 U/mL= Moderate-High Positive  |
|  IgA/IgG | ≤16 U/mL= Negative
16-24 U/mL=Equivocal
>24 U/mL=Positive | ≤20 U/mL= Negative
20-30 U/mL=Weak Positive
>30 U/mL= Moderate-High Positive  |

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

CLSI EP06-A: Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline

CLSI EP07-A2: Interference Testing in Clinical Chemistry, Approved Guideline – Second Edition

CLSI EP9-A2: Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline – Second Edition

CSLI EP17-A2: 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

CLSI EP25-A: Evaluation of Stability of In Vitro Diagnostic Reagents

CLSI H18-A4: Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests

## L. Test Principle:

The AESKULISA® DGP assays are solid phase indirect noncompetitive immunoassays. The antigen (deaminated gliadin specific peptides) is coated to 96 well microtiter plates. Antibodies specific for DGP present in the diluted patient sera bind to the synthetic gliadin antigen immobilized on wells of a microtiter plate. The formed antigen-antibody complex then interacts with the enzyme-labeled anti-human antibody conjugate that is added to each well and reacts with a chromogenic substrate to develop a colored reaction product. A quantitative determination of antibody concentration is obtained by absorbance measurement of the colored solution using a spectrophotometric microtiter plate reader. The intensity of color formation from the chromogen is a

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function of the amount of conjugate bound to the antigen-antibody complex and thus is proportional to the initial concentration of antibodies in the patient sera.

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

### 1. Analytical performance:

#### a. Precision/Reproducibility:

For the semi-quantitative claim, studies were performed with six sera samples with analyte levels across the reportable range of each assay. Each sample was tested in 8 replicates in 5 runs in 5 days with 1 reagent lot (n = 40). Lot-to-lot precision study was performed with the same samples. The same antigen but a different lot of conjugate was used for each of the three lots. The results are summarized in the tables below:

AESKULISA DGP-A (assay range 1.74-300 U/mL; 12-18 U/mL equivocal)

|   | Intra-assay |   | Inter-assay |   | Lot-to-Lot  |   |
| --- | --- | --- | --- | --- | --- | --- |
|  Mean (U/mL) | SD | %CV | SD | %CV | SD | %CV  |
|  2.7 | 0.3 | 11.2 | 0.6 | 21.0 | 0.5 | 17.6  |
|  12.9 | 0.9 | 6.9 | 1.4 | 10.5 | 1.2 | 9.1  |
|  16.7 | 1.6 | 9.6 | 1.8 | 10.7 | n/d | n/d  |
|  49.9 | 2.4 | 4.7 | 5.3 | 10.6 | 4.3 | 8.2  |
|  97.2 | 5.2 | 5.4 | 9.9 | 10.2 | 8.8 | 9.0  |
|  209.3 | 12.2 | 5.7 | 29.7 | 14.2 | 24.4 | 10.8  |

AESKULISA DGP-G (assay range 2.09-300 U/mL; 12-18 U/mL equivocal)

|   | Intra-assay |   | Inter-assay |   | Lot-to-Lot  |   |
| --- | --- | --- | --- | --- | --- | --- |
|  Mean (U/mL) | SD | %CV | SD | %CV | SD | %CV  |
|  3.2 | 0.4 | 11.3 | 0.7 | 21.5 | 0.2 | 7.6  |
|  12.1 | 1.2 | 10.4 | 1.8 | 14.8 | 1.4 | 12.4  |
|  19.5 | 1.8 | 9.0 | 2.0 | 10,0 | n/d | n/d  |
|  24.3 | 2.8 | 11.7 | 3.2 | 13.0 | 2.0 | 9.1  |
|  86.2 | 8.0 | 9.3 | 9.3 | 10.8 | 5.8 | 7.2  |
|  256.9 | 21.7 | 8.5 | 30.4 | 11.8 | 22.7 | 8.6  |

AESKULISA DGP-Check (assay range 1.84-300 U/mL; 16-24 U/mL equivocal)

|   | Intra-assay |   | Inter-assay |   | Lot-to-Lot  |   |
| --- | --- | --- | --- | --- | --- | --- |
|  Mean (U/mL) | SD | %CV | SD | %CV | SD | %CV  |
|  11.5 | 1.2 | 10.8 | 1.4 | 12.2 | 1.3 | 12.4  |
|  18.9 | 1.2 | 10.3 | 1.4 | 12.2 | 1.29 | 12.4  |
|  28.8 | 3.6 | 12.5 | 2.3 | 12.2 | 2.1 | 11.0  |
|  64.0 | 5.2 | 8.2 | 3.8 | 13.0 | 3.3 | 11.0  |
|  128.0 | 8.9 | 7.1 | 18.5 | 14.4 | 10.3 | 8.1  |

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For the qualitative claim, the same 6 samples were evaluated. Negative samples were 100% negative and positive samples were 100% positive. Results of the equivocal and positive samples close to the upper limit of the equivocal zone are summarized below:

|  Sample concentration | negative | Equivocal | positive  |
| --- | --- | --- | --- |
|  DGP-A (12-18U/mL equivocal zone)  |   |   |   |
|  12.9 U/mL | 30.0% | 70.0% | 0.0%  |
|  16.7 U/mL | 0.0% | 75.0% | 25.0%  |
|  DGP-G (12-18U/mL equivocal zone)  |   |   |   |
|  12.1 U/mL | 42.5% | 57.5% | 0.0%  |
|  19.5 U/mL | 0.0% | 20.0% | 80.0%  |
|  24.3 U/mL | 0.0% | 5.0% | 95.0%  |
|  DGP-Check (16-24U/mL equivocal zone)  |   |   |   |
|  18.9 U/mL | 15.0% | 85.0% | 0.0%  |
|  28.8 U/mL | 5.0% | 95.0% | 0.0%  |

## b. Linearity/assay reportable range:

Three positive serum samples were serially diluted using a negative serum sample and tested in duplicates. A calculation of the percent recovery and a regression analysis were performed on the results for each assay. The samples with &gt; ± 10% recovery from the expected value were typically highly diluted samples.

The results are summarized below:

|  Dilution range U/mL | Slope (95%CI) | Y-intercept (95%CI) | R²  |
| --- | --- | --- | --- |
|  DGP-A  |   |   |   |
|  331.9 - 35.6 | 1.016 (0.91 to 1.13) | -12.7 (-40.19 to 14.78) | 0.988  |
|  89.6 - 5.3 | 1.015 (0.88 to 1.15) | 5.24 (-18.63 to 8.16) | 0.983  |
|  13.9 - 1.3 | 0.974 (0.803 to 1.14) | -0.706 (-2.31 to 0.89) | 0.97  |
|  Combined | y = -1.2987 + 1.0040x R² 0.9958  |   |   |
|  DGP-G  |   |   |   |
|  313.9 - 42.3 | 0.979 (0.89 to 1.06) | 2.32 (-14.66 to 19.3) | 0.993  |
|  119.2 -13.7 | 0.927 (1.107 to 1.11) | -3.37 (-10.20 to 3.47) | 0.992  |
|  16.7 - 1.2 | 1.08 (0.93 to 1.23) | -1.06 (-2.70 to 0.58) | 0.980  |
|  Combined | y = -0.5213 + 0.9905x R² 0.9969  |   |   |

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|  Dilution range U/mL | Slope (95%CI) | Y-intercept (95%CI) | R²  |
| --- | --- | --- | --- |
|  DGP-Check  |   |   |   |
|  Dilution range U/mL | Slope (95%CI) | Y-intercept (95%CI) | R²  |
|  392.5-26.9 | 0.988 (088 to 1.09) | 2.926 (-19.51 to 25.37) | 0.989  |
|  156.5- 11.2 | 1.044 (0.958 to 1.13) | -5.27 (-10.18 to -0.37) | 0.993  |
|  14.0-1.3 | 1.002 (0.904 to 1.10) | -0.479 (-1.35 to 0.39) | 0.991  |
|  Combined | y = -2.8031 + 0.9827x R² 0.9941  |   |   |

The DGP-A claimed linear range is 1.74 – 300 U/mL

The DGP-G claimed linear range is 2.1 – 300 U/mL

The DGP-Check claimed linear range is 1.84 – 300 U/mL

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

Traceability:

There are no international standards for the gliadin antibodies. The results are reported in arbitrary units (U/mL). In order to have traceability with newly made calibrators, each new lot of calibrators is assayed on an already cleared kit and compared to the exiting calibrators.

Calibrators and Controls:

The calibrators are human serum in standard buffer. There are 6 levels (A-F) with assigned values from 0-300 U/mL. Calibrators E to Cal B are generated by diluting Cal F according to the dilution scheme shown in table below. The cut-off calibrator for the qualitative analysis is derived from Cal F by diluting Cal F to 15 U/mL for IgA and IgG and 20 U/mL for IgA/G.

|  Calibrator | Assigned Units (U/mL) | Dilution Range  |
| --- | --- | --- |
|  Cal F | 300 |   |
|  Cal E | 100 | 1:3 dil of F  |
|  Cal D | 30 | 1:3 dil of E  |
|  Cal C | 10 | 1:3 dil of D  |
|  Cal B | 3 | 1:3 dil of C  |
|  Cal A | 0 | Buffer (contains no sera)  |

Calibrator curve is acquired by fitting the values of 6 calibrators using a 4 parameter Lin-Log fit.

The negative control contains negative human serum in buffer. The positive control is from Cal F by diluting Cal F to 45-50 U/mL.

Kit Stability:

Shelf life stability was tested at real-time. Three lots of the assay kit, including all

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components of the kit, were stored at  $2 - 8^{\circ}\mathrm{C}$ . At different time points (0, 6 months, 12 months and 18 months), three samples with low, medium and high level of the analyte were tested in duplicate in one assay run. The results were compared to the results of the same samples tested at time  $= 0$ . The results support an unopened/shelf-life of 18 months at  $2 - 8^{\circ}\mathrm{C}$ .

Open vial stability - 4 samples - high negative, cut-off, low positive and high positive (approximately 10, 15, 30-70 and  $&gt;100\mathrm{U / mL}$ ) - were tested on different days on DGP-A, G and Check. The recovery results after 1 month were  $96\%$  to  $112.7\%$ .

Transport stability – the kit was assayed with 4 samples (negative, low, medium, high); each sample was tested in duplicate after being for 2 weeks at  $37^{\circ}\mathrm{C}$  and compared to  $t = 0$ . The stability results are summarized below:

|  Stability | DGP-A/DGP-G/DGP-Check  |
| --- | --- |
|  Kit shelf life (2-8°C) | 18 months  |
|  Transport stability (37°C) | 2 weeks  |
|  Reconstituted buffers | 1 month  |
|  Open kit stability (2-8°C) | 28 days  |
|  Serum samples | Up to 4 freeze/thaw cycles  |

# d. Detection limit:

The Limit of Blank (LoB) was based on 60 determinations of a blank sample and was estimated as the  $95\%$  percentile of the distribution. The Limit of Detection (LoD) was calculated according to the equation: the  $\mathrm{LoB} + c_{\beta}\mathrm{x}$  SD where SD, the standard deviation, was determined by assaying eight samples with analyte level near the lower limit of the reportable range in eight replicates. The results are summarized below:

|   | LoB (U/mL) | LoD (U/mL)  |
| --- | --- | --- |
|  AESKULISA DGP-A | 0.53 | 1.69  |
|  AESKULISA DGP-G | 0.30 | 1.83  |
|  AESKULISA DGP-Check | 0.20 | 1.44  |

# e. Analytical specificity:

# Interference:

Interferences were assessed by testing 4 serum samples with analyte concentrations across the assay range. Each sample was spiked with interfering substances and tested in duplicates. The data demonstrated that the assay was not affected by high levels of Rheumatoid Factor (400 IU/mL), Bilirubin (20 mg/dL), Triglyceride (3000 mg/dL), and Hemoglobin (800 mg/dL). The data is summarized in the table below:

|   | Percent Recovery (%)  |   |   |
| --- | --- | --- | --- |
|  Interfering substance (concentration) | DGP-A | DGP-G | DGP-Check  |
|  Rheumatoid Factor (400 IU/mL) | 93.4-105.9 | 99.4-107.8 | 96.9-113.9  |
|  Bilirubin (20 mg/dL) | 87.4-112.6 | 98.4-117.7 | 102.5-110.5  |
|  Triglyceride (3000 mg/dL) | 89.2-101.9 | 93.9-97.3 | 87.3-107.2  |
|  Hemoglobin (800 mg/dL) | 91.5-95.5 | 95.6-101.6 | 86.9-105.7  |

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# Cross-reactivity:

Cross-reactivity was tested using samples from other autoimmune conditions. The samples and results are summarized in the table below:

|  Diagnosis | Crossreactivity  |   |   |
| --- | --- | --- | --- |
|   |  DGP-A pos >18 U/mL | DGP-G pos >18 U/mL | DGP-Check pos >24 U/mL  |
|  Autoimmune Hepatitis | 0/5 (0%) | 0/5 (0%) | 0/6 (0%)  |
|  CCP | 0/5 (0%) | 0/5 (0%) | 0/5 (0%)  |
|  CCP; Rheumatoid Factor | 0/11 (0%) | 0/11 (0%) | 0/11 (0%)  |
|  Crohns Disease | ND | ND | 0/7 (0%)  |
|  Healthy | 0/99 (0%) | 0/99 (0%) | 1/99 (1%)  |
|  non-DH/CD controls (unspecified, diagnosis unknown) | 1/56 (1.8%) | 3/56 (5.4%) | 3/56 (5.4%)  |
|  Rheumatoid Arthritis | 0/18 (0%) | 0/18 (0%) | 0/18 (0%)  |
|  SLE | 0/13 (0%) | 0/13 (0%) | 0/23 (0%)  |
|  Vasculitis | 0/2 (0%) | 0/2 (0%) | 0/3 (0%)  |
|  Total | 1/209 (0.5%) | 3/209 (1.4%) | 4/228 (1.8%)  |

# f. Assay cut-off:

The assay cut-off was established by measuring serum samples from 160 healthy donors and 139 subjects with other autoimmune diseases expected to be negative for DPG antibodies. These samples were not used in the clinical evaluation study. The cut-off was determined from the mean  $\pm 3$  standard deviations. The results are shown in the table below:

|   | Negative | Equivocal | Positive  |
| --- | --- | --- | --- |
|  DGP-A | < 12 U/mL | 12–18 U/mL | > 18 U/mL  |
|  DGP-G | < 12 U/mL | 12–18 U/mL | > 18 U/mL  |
|  DGP-Check | < 16 U/mL | 16-24 U/mL | > 24 U/mL  |

# 2. Comparison studies:

# a. Method comparison with predicate device

For the method comparison study, 431 serum samples were tested by both the new and predicate devices (see table below). Patients with Celiac Disease (CD) were diagnosed by serology and confirmed with biopsy. Patients with Dermatitis Herpetiformis (DH) were diagnosed based on skin biopsy and serology.

|  Disease Group | Number of Samples  |
| --- | --- |
|  Celiac Disease (CD) | 79  |
|  CD IgA Def | 16  |
|  CD suspect | 41  |
|  CD suspect IgA Def | 2  |
|  Dermatitis Herpetiformis (DH) | 65  |
|  Total | 203  |

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|  Disease Controls | Number of Samples  |
| --- | --- |
|  Autoimmune Hepatitis | 6  |
|  CCP | 5  |
|  CCP; Rheumatoid Factor | 11  |
|  Crohns Disease (DGP-Check only) | 7  |
|  Rheumatoid Arthritis | 18  |
|  SLE | 23  |
|  Vasculitis | 3  |
|  Non DH-CD (diagnosis unspecified/unknown) | 56  |
|  Total | 129  |
|  Healthy Controls | 99  |
|  Total | 431  |

For the comparison study calculations, samples outside of the reportable range of both devices and the 99 normal samples were excluded. For DGP Check testing, 12 diluted samples were included to cover the assay range. Results are summarized below:

# AEKULISA DPG-A

|  DGP-A | INOVA (U/mL)  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Positive (>20) | Negative (≤20) | Total  |
|  AESKULISA DGP-A Test (U/mL) | Positive (>18) | 88 | 16* | 104  |
|   |  Equivocal (18-12) | 7** | 20 | 27  |
|   |  Negative (<12) | 13** | 64 | 77  |
|   |  Total | 108 | 100 | 208  |

*10 CD, 2 DH, 3 suspected of CD, 1 non-DH/CD
**16 CD, 1 suspected of CD, 2 DH, 1non-DH/CD

|  DGP-A Equivocal as negative | INOVA (U/mL)  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Positive >20 | Negative ≤20 | Total  |
|  AESKU (U/mL) | Positive >18 | 88 | 16 | 104  |
|   |  Negative ≤18 | 20 | 84 | 104  |
|   |  Total | 108 | 100 | 208  |

Positive agreement:  $81.5\%$  (88/108)  $(95\% \mathrm{CI}:73.1 - 87.7\%)$
Negative agreement:  $84.0\%$  (84/100)  $(95\% \mathrm{CI}:75.6 - 89.9\%)$
Total agreement:  $82.7\%$  [(88+84)/208] (95% CI: 77.0 - 87.2%

|  DGP-A Equivocal as positive | INOVA (U/mL)  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Positive >20 | Negative ≤20 | Total  |
|  AESKU (U/mL) | Positive ≥12 | 95 | 36 | 131  |
|   |  Negative <12 | 13 | 64 | 77  |
|   |  Total | 108 | 100 | 208  |

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Positive % agreement: 88.0% (95/108) (95% CI: 80.5 - 92.8%)
Negative % agreement: 64.0% (64/100) (95% CI: 54.2 - 72.7%)
Total % agreement: 76.4% [(95+64)/208] (95% CI: 70.2 - 81.7%)

# AESKULISA DGP-G

|  DGP-G | INOVA (U/mL)  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Positive (>20) | Negative (≤20) | Total  |
|  AESKULISA DGP-G (U/mL) | Positive (>18) | 136 | 13* | 149  |
|   |  Equivocal (18-12) | 8** | 13 | 21  |
|   |  Negative (<12) | 0 | 48 | 48  |
|   |  Total | 144 | 74 | 218  |

*7 CD, 4 DH, 2 non-DH/CD
**2 CD, 3 suspected of CD, 3 DH

|  DGP-G
Equivocal as negative | INOVA (U/mL)  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Positive >20 | Negative ≤20 | Total  |
|  AESKU (U/mL) | Positive >18 | 136 | 13 | 149  |
|   |  Negative ≤18 | 8 | 61 | 69  |
|   |  Total | 144 | 74 | 218  |

Positive % agreement: 94.4% (136/144) (95% CI: 89.4 - 97.2%)
Negative % agreement: 82.4% (61/74) (95% CI: 72.2 - 89.4%)
Total % agreement: 90.4% [(136+61)/218] (95% CI: 85.7 - 93.6%)

|  DGP-G
Equivocal as positive: | INOVA (U/mL)  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Positive >20 | Negative ≤20 | Total  |
|  AESKU (U/mL) | Positive ≥12 | 144 | 26 | 170  |
|   |  Negative <12 | 0 | 48 | 48  |
|   |  Total | 144 | 74 | 218  |

Positive % agreement: 100% (144/144) (95% CI: 97.4 - 100.0%)
Negative % agreement: 64.9% (48/74) (95% CI: 53.5 - 74.8%)
Total % agreement: 88.1% [(144+48)/218] (95% CI: 83.1 - 91.7%)

# AESKULISA DPG-Check:

|  DGP-Check | INOVA (U/mL)  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Positive (>20) | Negative (≤20) | Total  |
|  AESKULISA DGP-Check (U/mL) | Positive (>24) | 122 | 8* | 130  |
|   |  Equivocal (16-24) | 14** | 5 | 19  |
|   |  Negative (<16) | 7** | 60 | 67  |
|   |  Total | 143 | 73 | 216  |

*6 CD, 1 suspected of CD, 1 non-DH/CD
**14 equivocal [7 CD (diluted); 6 suspected of CD; 1 DH]
**7 negative (2 CD; 2 suspected of CD suspect; 3 DH)

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12

|  DGP-Check
Equivocal as negative | INOVA (U/mL)  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Positive >20 | Negative ≤20 | Total  |
|  AESKU
(U/mL) | Positive >24 | 122 | 8 | 130  |
|   |  Negative ≤24 | 21 | 65 | 86  |
|   |  Total | 143 | 73 | 216  |

Positive % agreement: 85.3% (122/143) (95% CI: 78.6% – 90.2%)
Negative % agreement: 89.0% (65/73) (95% CI: 79.8% – 94.3%)
Total % agreement: 86.6% [(122+65)/216] (95% CI: 81.4 – 90.5%)

|  DGP-Check
Equivocal as positive | INOVA (U/mL)  |   |   |   |
| --- | --- | --- | --- | --- |
|   |   |  Positive >20 | Negative ≤20 | Total  |
|  AESKU
(U/mL) | Positive ≥16 | 136 | 13 | 149  |
|   |  Negative <16 | 7 | 60 | 67  |
|   |  Total | 143 | 73 | 216  |

Positive % agreement: 95.1% (136/143) (95% CI: 90.2% – 97.6%)
Negative % agreement: 82.2% (60/73) (95% CI: 71.9% – 89.3%)
Total % agreement: 90.7% [(136+60)/216] (95% CI: 86.1 – 93.9%)

b. Matrix comparison:
Not applicable. Each assay uses only serum as the matrix.

3. Clinical studies:

a. Clinical Sensitivity and Specificity:
Serum samples used in the method comparison studies were also used to determine sensitivity and specificity of each assay. The following samples were excluded from the calculations: 43 samples with suspected CD and CD IgA deficient diagnosis and 99 healthy controls. For the DGP-A assay, the 16 CD samples with IgA deficiency were also excluded. For the DGP-Check, the 12 diluted samples were also excluded.

The tables below summarize the groups of diagnosed patients evaluated by each assay and the calculated specificity and sensitivity results with equivocals as positive or negative:

AESKULISA DGP-A:

|  DGP-A
Equivocal as negative: | Diagnosis  |   |   |
| --- | --- | --- | --- |
|   |  Positive | Negative | Total  |
|  Positive >18 U/mL | 110 | 1 | 111  |
|  Negative ≤18 U/mL | 34 | 109 | 143  |
|  Total | 144 | 110 | 254  |

Sensitivity: 76.4% (110/144) (95% CI: 68.8 - 82.6)
Specificity: 99.1% (109/110) (95% CI: 95.0 - 99.8)
Overall Agreement: 86.2% [(110+109)/254] (95% CI: 81.4 – 89.9)

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|  DGP-A
Equivocal as positive | Diagnosis  |   |   |
| --- | --- | --- | --- |
|   |  Positive | Negative | Total  |
|  Positive ≥12 U/mL | 123 | 23 | 146  |
|  Negative <12 U/mL | 21 | 87 | 108  |
|  Total | 144 | 110 | 254  |

Sensitivity: 85.4% (123/144) (95% CI: 78.7 - 90.3)

Specificity: 79.1% (87/110) (95% CI: 70.6 - 85.6)

Overall Agreement: 82.7% [(123+187)/254] (95% CI: 77.6 - 86.8)

|  DGP-A | AESKU  |   |   |
| --- | --- | --- | --- |
|  Disease Group | POS (>12) | POS (>18) | Total  |
|  CD | 60(75.9%) | 51(64.6%) | 79  |
|  DH | 63(96.9%) | 59(90.8%) | 65  |
|  SLE | 7(53.8%) | 0(0%) | 13  |
|  Vasculitis | 0(0%) | 0(0%) | 2  |
|  Rheumatoid Arthritis | 2(11.1%) | 0(0%) | 18  |
|  CCP | 1(20.0%) | 0(0%) | 5  |
|  CCP; Rheumatoid Factor | 1(9.1%) | 0(0%) | 11  |
|  Autoimmune Hepatitis | 0(0%) | 0(0%) | 5  |
|  non-DH/CD controls
(diagnosis not specified) | 12(21.4%) | 1(1.8%) | 56  |
|  Total | 146(57.5%) | 111(43.7%) | 254  |

# AESKULISA DGP-G:

|  DGP-G
Equivocal as negative | Diagnosis  |   |   |
| --- | --- | --- | --- |
|   |  Positive | Negative | Total  |
|  Positive >18 U/mL | 150 | 3 | 153  |
|  Negative ≤18 U/mL | 10 | 107 | 117  |
|  Total | 160 | 110 | 270  |

Sensitivity: 93.8% (150/160) (95% CI: 88.9 - 96.6)

Specificity: 97.3% (107/110) (95% CI 92.3 - 99.1)

Overall Agreement: 95.2% [(150+107)/270] (95% CI: 91.9 - 97.2)

|  DGP-G
Equivocal as positive: | Diagnosis  |   |   |
| --- | --- | --- | --- |
|   |  Positive | Negative | Total  |
|  Positive ≥12 U/mL | 159 | 31 | 190  |
|  Negative <12 U/mL | 1 | 79 | 80  |
|  Total | 160 | 110 | 270  |

Sensitivity: 99.4% (159/160) (95% CI: 96.6 - 99.9)

Specificity: 71.8% (79/110) (95% CI: 62.8 - 79.4)

Overall Agreement: 88.2% [(159+79)/270] (95% CI: 83.8 - 91.5)

{13}

|  DGP-G | AESKU  |   |   |
| --- | --- | --- | --- |
|  Disease Group | POS >12 | Pos >18 | Total  |
|  CD | 79(100%) | 75(94.9%) | 79  |
|  CD IgA Def | 16(100%) | 16(100%) | 16  |
|  DH | 64(98.5%) | 59(90.8%) | 65  |
|  SLE | 9(69.2%) | 0(0%) | 13  |
|  Vasculitis | 0(0%) | 0(0%) | 2  |
|  Rheumatoid Arthritis | 5(27.8%) | 0(0%) | 18  |
|  CCP | 1(20%) | 0(0%) | 5  |
|  CCP; Rheumatoid Factor | 4(36.4%) | 0(0%) | 11  |
|  Autoimmune Hepatitis | 4(80%) | 0(0%) | 5  |
|  non-DH/CD controls | 8(14.3%) | 3(5.4%) | 56  |
|  Total | 190(70.4%) | 153(56.7%) | 270  |

AESKULISA DGP-Check:

|  DGP-Check Equivocal as negative | Diagnosis  |   |   |
| --- | --- | --- | --- |
|   |  Positive | Negative | Total  |
|  Positive >24 U/mL | 151 | 3 | 154  |
|  Negative ≤24 U/mL | 9 | 126 | 135  |
|  Total | 160 | 129 | 289  |

Sensitivity: 94.4% (151/160) (95% CI: 89.7 - 97.0)

Specificity: 97.7% (126/129) (95% CI 93.4 - 99.2)

Overall Agreement:  $95.9\%$  [(151+126)/289] (95% CI: 92.9 - 97.6)

|  DGP-Check Equivocal as positive: | Diagnosis Group  |   |   |
| --- | --- | --- | --- |
|   |  Positive | Negative | Total  |
|  Positive ≥16 U/mL | 152 | 13 | 165  |
|  Negative <16 U/mL | 8 | 116 | 124  |
|  Total | 160 | 129 | 289  |

Sensitivity:  $95.0\%$  (152/160)  $(95\% \mathrm{CI}: 90.5 - 97.5)$

Specificity:  $89.9\%$  (116/129)  $(95\% \mathrm{CI}: 83.5 - 94.0)$

Overall Agreement:  $92.7\%$  [(152+116)/289] (95% CI: 89.2 - 95.2)

|  DGP-Check | AESKU  |   |   |
| --- | --- | --- | --- |
|  Disease Group | POS (>=16) | POS (>24) | Total  |
|  CD | 77(97.5%) | 77(97.5%) | 79  |
|  CD IgA Def | 15(93.8%) | 15(93.8%) | 16  |
|  DH | 60(92.3%) | 59(90.8%) | 65  |
|  SLE | 7(30.4%) | 0(0%) | 23  |
|  Vasculitis | 0(0%) | 0(0%) | 3  |
|  Crohns Disease | 2(28.6%) | 0(0%) | 7  |
|  Rheumatoid Arthritis | 0(0%) | 0(0%) | 18  |
|  CCP | 0(0%) | 0(0%) | 5  |

{14}

|  DGP-Check | AESKU  |   |   |
| --- | --- | --- | --- |
|  Disease Group | POS (>=16) | POS (>24) | Total  |
|  CCP; Rheumatoid Factor | 1 (9.1%) | 0(0%) | 11  |
|  Autoimmune Hepatitis | 0(0%) | 0(0%) | 6  |
|  non-DH/CD controls | 3 (5.4%) | 3(5.4%) | 56  |
|  Total | 165(57.1%) | 154(53.3%) | 289  |

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

Not applicable

4. Clinical cut-off:

See assay cut-off.

5. Expected values/Reference range:

The expected value in the general population is negative. A study of 133 apparently healthy blood donors was performed on all three AESKULISA kits. The samples included 69 female, 64 male; 116 in the age group of 16-45, 17 in the age group of 46+. The results are summarized in the table below:

|   | Healthy Samples  |   |   |
| --- | --- | --- | --- |
|  Results | DGP-A | DGP-G | DGP-Check  |
|  Max | 13.7 IU/mL | 18.2 IU/mL | 28.4 IU/mL  |
|  Mean±SD | 3.1±1.8 IU/mL | 3.2±2.2 IU/mL | 8.3±4.4 IU/mL  |
|  95% CI | 97.2 - 100.0% | 95.9 – 99.9% | 95.9 - 99.9%  |

N. Proposed Labeling:

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

O. Conclusion:

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

---

**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/MST/K132082](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/MST/K132082)

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