Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a standard chemiluminescent immunoassay process and data analysis based on predefined master and working curves, with no mention of AI or ML algorithms for data interpretation or decision making.

Therapeutic

No.
This device is an in-vitro diagnostic (IVD) device used to aid in the diagnosis of celiac disease and dermatitis herpetiformis by detecting specific antibodies, not to provide therapy or treatment.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the device "can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of celiac disease and dermatitis herpetiformis." This indicates its purpose is to assist in diagnosis.

SaMD (Software as a Medical Device)

No

The device is a chemiluminescent immunoassay kit that includes reagents, calibrators, and controls, which are physical components used in conjunction with an instrument (BIO-FLASH®) to perform the test. It is not solely software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states that the device is for the "semi-quantitative determination of IgA antibodies to synthetic, deamidated gliadin peptides in human serum" and "semi-quantitative detection of IgG antibodies to synthetic, deamidated gliadin peptides in human serum." It also states that the results are used "in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of celiac disease and dermatitis herpetiformis." This clearly indicates that the device is intended to be used on samples taken from the human body (serum) to provide information for diagnostic purposes.
Device Description: The description details a "chemiluminescent immunoassay" that measures antibodies in "human serum samples." This is a common method used in IVD devices.
Components: The device includes reagents, calibrators, and controls, which are typical components of IVD kits used in a laboratory setting.
Performance Studies: The document includes extensive performance studies (Precision, Limit of Detection, Analytical Measuring Range, Cut-off, reference range, Linearity, Interference, Cross-reactivity, Comparison with predicate device, Clinical sensitivity, specificity, and Stability) which are required for the validation and regulatory approval of IVD devices.
Predicate Devices: The mention of "Predicate Device(s)" with 510(k) numbers (K052143 and K052142) further confirms that this device is being compared to other legally marketed IVD devices.

All these elements align with the definition and characteristics of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The QUANTA Flash™ DGP IgA is a chemiluminescent immunoassay for the semi-quantitative determination of of IgA antibodies to synthetic, deamidated gliadin peptides in human serum. The measurement 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 semi-quantitative detection of IgG antibodies to synthetic, deamidated gliadin peptides in human serum. The measurement 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 IgA deficient and IgA deficient patients, as well as dermatitis herpetiformis.

The QUANTA Flash DGP IgA Calibrators are intended for use with the QUANTA Flash DGP IgA chemiluminescent immunoassay (CIA). Each calibrator establishes a point 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 IgA Controls are intended for quality control purposes of the QUANTA Flash DGP lgA 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.

Product codes (comma separated list FDA assigned to the subject device)

MST, JIT, JJX

Device Description

Synthetic deamidated gliadin peptide is coated onto the surface of paramagnetic beads (microparticles), which are stored in the reagent cartridge under conditions that preserve the antigen in its reactive state. The reagent cartridge is then loaded onto and used by the BIO-FLASH instrument.

Serum samples are prediluted by the instrument with system rinse buffer, and added to disposable plastic cuvettes. Small amounts of the diluted patient serum, the DGP beads, and assay buffer are all combined into a second cuvette, and mixed. This cuvette is incubated at 37℃. The beads are then magnetized and washed several times. Isoluminol conjugated anti-human IgA (or IgG) antibody is then added to the cuvette, and incubated at 37°C. Again, the beads are magnetized and washed repeatedly. The isoluminol conjugate produces a luminescent reaction when reagents ("Triggers") are added to the cuvette. 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.

For quantitation, the QUANTA Flash DGP IgA and IgG assays utilize a predefined lot specific Master Curve that is uploaded onto the instrument through the reagent cartridge barcode. Every new lot number of reagent cartridge must be calibrated before first use with the QUANTA Flash DGP IgA and IgG Calibrators. Based on the results obtained with the two Calibrators included in the Calibrator set, an instrument specific Working Curve is created, which is used to calculate chemiluminescent units (CU) from the RLU obtained for each patient.

The QUANTA Flash DGP IgA reagent cartridge contains the following reagents:

DGP coated paramagnetic beads in buffer, containing protein stabilizers and a. preservative.
Assay buffer colored pink, containing Tris-buffered saline, Tween 20, protein b. stabilizers and preservatives.
Tracer IgA Isoluminol labeled anti-human IgA antibodies in buffer, containing protein ن stabilizers and preservative.

The QUANTA Flash DGP IgG reagent cartridge contains the following reagents:

DGP coated paramagnetic beads in buffer, containing protein stabilizers and a. preservative.
Assay buffer colored pink, containing Tris-buffered saline, Tween 20, protein ﻗ stabilizers and preservatives.
Tracer IgG Isoluminol labeled anti-human IgA antibodies in buffer, containing protein ﻥ stabilizers and preservative.

The QUANTA Flash™ DGP IgA Calibrators and the QUANTA Flash™ DGP IgG Calibrators kits each contain 2 vials of Calibrators:

QUANTA Flash™ DGP IgA Calibrators:

QUANTA Flash DGP IgA Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human IgA antibodies to DGP in buffer, protein stabilizers, and preservatives.
QUANTA Flash DGP IgA Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL . prediluted, ready to use reagent. Calibrators contain human IgA antibodies to DGP in buffer, protein stabilizers, and preservatives.

QUANTA Flash™ DGP IgG Calibrators:

QUANTA Flash DGP IgG Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL . prediluted, ready to use reagent. Calibrators contain human IgG antibodies to DGP in buffer, protein stabilizers, and preservatives.
QUANTA Flash DGP IgG Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human IgG antibodies to DGP in buffer, protein stabilizers, and preservatives.

The QUANTA Flash™ DGP IgA Controls kit and the QUANTA Flash™ DGP IgG Controls kits each contain 2 vials of Negative Control and two vials of Positive Control:

QUANTA Flash™ DGP IgA Controls:
QUANTA Flash™ DGP IgA Negative Control: Two (2) barcode labeled tubes containing 0.5 ml, ready to use reagent. Controls contain human IgA antibodies to DGP in buffer, protein stabilizers, and preservatives.
QUANTA Flash™ DGP IgA Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human IgA antibodies to DGP in buffer, protein stabilizers, and preservatives.

QUANTA Flash™ DGP IgG Controls:
QUANTA Flash™ DGP IgG Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human IgG antibodies to DGP in buffer, protein stabilizers, and preservatives.
QUANTA Flash™ DGP IgG Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human IgG antibodies to DGP in buffer, protein stabilizers, and preservatives.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

1 month – 2 years, 2 years - 12 years, 12-21 years, >21 years, 2367.3 CU (DGP IgA) or >1936.7 CU (DGP IgG), which are diluted by a factor of 10.

Key Results: Differences between manual and automatic results for DGP IgA were 11% and 15%, and for DGP IgG 19% and 5% (within the ± 20% acceptance limit).

High Concentration Hook Effect:

Key Results: No hook effect detected up to 5167.2 CU in DGP IgA and up to 4323.7 CU in DGP IgG.

Interference:

Study Type: Performed according to CLSI EP07-A2, Interference Testing in Clinical Chemistry.
Acceptance Criteria: 85% - 115% recovery, or +/- 4 CU difference, whichever is greater.
Key Results (DGP IgA): No interference with hemoglobin (up to 200 mg/dL), triglycerides (up to 1000 mg/dL), cholesterol (up to 224.3 mg/dL), bilirubin (up to 10 mg/dL, with one exception at 5 mg/dL), and RF IgM (up to 500 IU/mL, with one exception at 500 IU/mL).
Key Results (DGP IgG): No interference with bilirubin (up to 10 mg/dL), hemoglobin (up to 200 mg/dL), triglycerides (up to 1000 mg/dL), cholesterol (up to 224.3 mg/dL), and RF IgM (up to 500 IU/mL, with one exception at 100 IU/mL).

Cross-reactivity:

DGP IgA: 201 patient samples with autoantibodies and infection-induced antibodies were tested; none were positive.
DGP IgG: 185 patient samples were tested; 5 out of 185 (3%) were positive, indicating lack of significant cross-reactivity.

Comparison with predicate device (Method comparison):

DGP IgA:
- N=96
- Positive Agreement = 91.5% (82.5-96.8%)
- Negative Agreement = 90.3% (74.2-98.0%)
- Total Agreement = 91.2% (83.9-95.9%)
- DH samples (N=21):
  - Positive Agreement = 85.7% (57.2%-98.2%)
  - Negative Agreement = 85.7% (42.1-99.6%)
  - Total Agreement = 85.7% (63.7%-97.0%)
DGP IgG:
- N=235
- Positive Agreement = 95.1% (88.0-98.7%)
- Negative Agreement = 83.6% (77.0-89.0%)
- Total Agreement = 87.6% (82.7-91.4%)
- DH samples (N=21):
  - Positive Agreement = 88.9% (65.3%-98.6%)
  - Negative Agreement = 100.0% (47.8%-100.0%)
  - Total Agreement = 91.3% (72.0%-98.9%)
- IgA deficient samples (N=21):
  - Positive Agreement = 71.4% (29.0%-96.3%)
  - Negative Agreement = 66.7% (22.3%-95.7%)
  - Total Agreement = 69.2% (38.6%-90.9%)

Clinical Sensitivity and Specificity:

QUANTA Flash DGP IgA:
- CD (n=147) and Not CD (n=352):
  - Sensitivity = 71.4% (63.4-78.6%)
  - Specificity = 100.0% (99.0-100%)
- DH (n=21) and Not DH (n=352):
  - Sensitivity = 61.9% (38.4-81.9%)
  - Specificity = 100.0% (99.0-100%)
- ROC Analysis (Celiac Disease): Area = 0.94, 95% CI (0.90 to 0.97), p 30 CU
Clinical sensitivity and specificity in CD:
- Sensitivity = 71.4% (95% CI: 63.4-78.6%)
- Specificity = 100.0% (95% CI: 99.0-100%)
Clinical sensitivity and specificity in DH:
- Sensitivity = 61.9% (95% CI: 38.4-81.9%)
- Specificity = 100.0% (95% CI: 99.0-100%)
ROC Analysis (Celiac Disease): Area = 0.94
ROC Analysis (Dermatitis Herpetiformis): Area = 0.79

QUANTA Flash DGP IgG:

Cut-off, reference range: Negative 30 CU
Clinical sensitivity and specificity in CD:
- Sensitivity = 89.2% (95% CI: 83.0-93.7%)
- Specificity = 97.3% (95% CI: 95.0-98.8%)
Clinical sensitivity and specificity in IgA deficient CD:
- Sensitivity = 56.3% (95% CI: 29.9-80.2%)
- Specificity = 97.3% (95% CI: 95.0-98.8%)
Clinical sensitivity and specificity in DH:
- Sensitivity = 69.6% (95% CI: 47.1-86.8%)
- Specificity = 97.3% (95% CI: 95.0-98.8%)
ROC Analysis (Celiac Disease): Area = 0.99
ROC Analysis (Dermatitis Herpetiformis): Area = 0.95

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

QUANTA Lite™ Gliadin IgA II, 510(k) number: K052143
QUANTA Lite™ Gliadin IgG II, 510(k) number: K052142

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 866.5750 Radioallergosorbent (RAST) immunological test system.

(a)
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.(b)
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.

Summary

0

K//3863

510(k) Summary

SEP 2 0 2012

This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| Submitter: | INOVA Diagnostics, Inc
9900 Old Grove Road,
San Diego, CA, 92131 | |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Purpose of submission: | New device | |
| Scientific contact: | Gabriella Lakos, Director of Research, Rheumatology
INOVA Diagnostics, Inc
9900 Old Grove Road, San Diego, CA, 92131
Phone: 858-586-9900/393
Fax: 858-863-0025
email: glakos@sd.inovadx.com | |
| Quality Systems contact: | Tana Keivens, Director, Quality Systems
INOVA Diagnostics, Inc
9900 Old Grove Road, San Diego, CA, 92131
Phone: 858-586-9900
Fax: 858-863-0025/351
email: tkeivens@sd.inovadx.com | |
| Preparation date: | 09/10/2012 (amended on 09/28/2012) | |
| Device name (assay kits): | Proprietary name: QUANTA Flash™ DGP IgA
QUANTA Flash™ DGP IgG
Common name: DGP IgA Chemiluminescent Immunoassay
DGP IgG Chemiluminescent Immunoassay
Classification name: Antibodies, Gliadin (21 CCFR 862.1690) | |
| Regulation Description | Radioallergosorbent (RAST) immunological test system | |
| Regulation Medical Specialty | Immunology | |
| Review Panel | Immunology | |
| Product Code | MST | |
| Regulation Number | 866.5750 | |
| Device Class | 2 | |
| Device name (Calibrators): | Proprietary name: QUANTA Flash™ DGP IgA Calibrators
QUANTA Flash™ DGP IgG Calibrators
Common name: DGP IgA Calibrators
DGP IgG Calibrators
Classification name: Calibrator, secondary | |
| Regulation Description | Calibrator | |
| Regulation Medical Specialty | Clinical Chemistry | |
| Product Code | JIT | |
| Regulation Number | 862.1150 | |
| Device Class | 2 | |
| Device name (Controls): | Proprietary name: | QUANTA Flash™ DGP IgA Controls
QUANTA Flash™ DGP IgG Controls |
| | Common name: | DGP IgA Controls
DGP IgG Controls |
| | Classification name: | single (specified) analyte controls (assayed and unassayed) |
| Regulation Description | Quality control material (assayed and unassayed) | |
| Regulation Medical Specialty | Clinical Chemistry | |
| Product Code | JJX | |
| Regulation Number | 862.1660 | |
| Device Class | 1 | |
| Predicate device(s): | QUANTA Lite™ Gliadin IgA II, 510(k) number: K052143
QUANTA Lite™ Gliadin IgG II, 510(k) number: K052142 | |

1

Device description:

Synthetic deamidated gliadin peptide is coated onto the surface of paramagnetic beads (microparticles), which are stored in the reagent cartridge under conditions that preserve the antigen in its reactive state. The reagent cartridge is then loaded onto and used by the BIO-FLASH instrument.

Serum samples are prediluted by the instrument with system rinse buffer, and added to disposable plastic cuvettes. Small amounts of the diluted patient serum, the DGP beads, and assay buffer are all combined into a second cuvette, and mixed. This cuvette is incubated at 37℃. The beads are then magnetized and washed several times. Isoluminol conjugated anti-human IgA (or IgG) antibody is then added to the cuvette, and incubated at 37°C. Again, the beads are magnetized and washed repeatedly. The isoluminol conjugate produces a luminescent reaction when reagents ("Triggers") are added to the cuvette. 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.

For quantitation, the QUANTA Flash DGP IgA and IgG assays utilize a predefined lot specific Master Curve that is uploaded onto the instrument through the reagent cartridge barcode. Every new lot number of reagent cartridge must be calibrated before first use with the QUANTA Flash DGP IgA and IgG Calibrators. Based on the results obtained with the two Calibrators included in the Calibrator set, an instrument specific Working Curve is created, which is used to calculate chemiluminescent units (CU)

2

from the RLU obtained for each patient.

The QUANTA Flash DGP IgA reagent cartridge contains the following reagents:

DGP coated paramagnetic beads in buffer, containing protein stabilizers and a. preservative.
Assay buffer colored pink, containing Tris-buffered saline, Tween 20, protein b. stabilizers and preservatives.
Tracer IgA Isoluminol labeled anti-human IgA antibodies in buffer, containing protein ن stabilizers and preservative.

The QUANTA Flash DGP IgG reagent cartridge contains the following reagents:

DGP coated paramagnetic beads in buffer, containing protein stabilizers and a. preservative.
Assay buffer colored pink, containing Tris-buffered saline, Tween 20, protein ﻗ stabilizers and preservatives.
Tracer IgG Isoluminol labeled anti-human IgA antibodies in buffer, containing protein ﻥ stabilizers and preservative.

The QUANTA Flash™ DGP IgA Calibrators and the QUANTA Flash™ DGP IgG Calibrators kits each contain 2 vials of Calibrators:

QUANTA Flash™ DGP IgA Calibrators:

QUANTA Flash DGP IgA Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human IgA antibodies to DGP in buffer, protein stabilizers, and preservatives.
QUANTA Flash DGP IgA Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL . prediluted, ready to use reagent. Calibrators contain human IgA antibodies to DGP in buffer, protein stabilizers, and preservatives.

QUANTA Flash™ DGP IgG Calibrators:

QUANTA Flash DGP IgG Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL . prediluted, ready to use reagent. Calibrators contain human IgG antibodies to DGP in buffer, protein stabilizers, and preservatives.
QUANTA Flash DGP IgG Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human IgG antibodies to DGP in buffer, protein stabilizers, and preservatives.

The QUANTA Flash™ DGP IgA Controls kit and the QUANTA Flash™ DGP IgG Controls kits each contain 2 vials of Negative Control and two vials of Positive Control:

QUANTA Flash™ DGP IgA Controls:

QUANTA Flash™ DGP IgA Negative Control: Two (2) barcode labeled tubes containing 0.5 ml, ready to use reagent. Controls contain human IgA antibodies to DGP in buffer, protein stabilizers, and preservatives.

QUANTA Flash™ DGP IgA Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human IgA antibodies to DGP in buffer, protein

3

stabilizers, and preservatives.

QUANTA Flash™ DGP IgG Controls:

QUANTA Flash™ DGP IgG Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human IgG antibodies to DGP in buffer, protein stabilizers, and preservatives.

QUANTA Flash™ DGP IgG Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human IgG antibodies to DGP in buffer, protein stabilizers, and preservatives.

Intended use:

The QUANTA Flash™ DGP IgA is a chemiluminescent immunoassay for the semi-quantitative determination of of IgA antibodies to synthetic, deamidated gliadin peptides in human serum. The measurement 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 semi-quantitative detection of IgG antibodies to synthetic, deamidated gliadin peptides in human serum. The measurement 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 IgA deficient and IgA deficient patients, as well as dermatitis herpetiformis.

The QUANTA Flash DGP IgA Calibrators are intended for use with the QUANTA Flash DGP IgA chemiluminescent immunoassay (CIA). Each calibrator establishes a point 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 IgA Controls are intended for quality control purposes of the QUANTA Flash DGP lgA 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.

Substantial equivalence:

The QUANTA Flash™ DGP IgA assay, the QUANTA Flash DGP IgA Calibrators and the QUANTA Flash DGP IgA Controls have the same intended use and assay principle as the predicate device. The QUANTA Flash™ DGP IgG assay, the QUANTA Flash DGP IgAG Calibrators and the QUANTA Flash DGP IgG Controls have the same intended use and assay principle as the predicate device.

4

Comparison to predicate device:

Similarities
Item	QUANTA Flash DGP IgA	Predicate Device
Intended use	Semi-quantitative determination of
IgA antibodies to synthetic,
deamidated gliadin peptides in human
serum.	Semi-quantitative detection of IgA
antibodies to gliadin in human serum
Assay methodology	Solid phase (heterogenous)
immunoassay	Solid phase (heterogeneous)
immunoassay
Traceability	International Reference Preparation is
not available	International Reference Preparation is
not available
Antigen	Synthetic, deamidated gliadin
peptides	Synthetic, deamidated gliadin peptides
Sample type	Serum	Serum
Shelf life	One year	One year

QUANTA Flash DGP IgA reagent kit

Differences
Item	QUANTA Flash DGP IgA	Predicate Device
Detection/
Operating principle	Chemiluminescent immunoassay	Enzyme-linked immunosorbent assay
Solid phase	Paramagnetic microparticles (beads)	96-well plate
Conjugate	Isoluminol conjugated anti-human IgA	HRP conjugated anti-human IgA
Calibration	Lot specific Master Curve + two
Calibrators (Sold separately)	Gliadin IgA II ELISA Low Positive
Gliadin IgA II ELISA High Positive
(Included in the kit)

QUANTA Flash DGP IgG reagent kit

Similarities
ltem	QUANTA Flash DGP IgG	Predicate Device
Intended use	Semi-quantitative determination of
lgG antibodies to synthetic,
deamidated gliadin peptides in
human serum.	Semi-quantitative detection of IgG
antibodies to gliadin in human serum
Assay methodology	Solid phase (heterogenous)
immunoassay	Solid phase (heterogenous)
immunoassay
Traceability	International Reference Preparation
is not available	International Reference Preparation is
not available
Antigen	Synthetic, deamidated gliadin
peptides	Synthetic, deamidated gliadin peptides
Sample type	Serum	Serum
Shelf life	One year	One year

5

Differences
Item	QUANTA Flash DGP IgG	Predicate Device
Detection/
Operating principle	Chemiluminescent immunoassay	Enzyme-linked immunosorbent assay
Solid phase	Paramagnetic microparticles (beads)	96-well plate
Conjugate	Isoluminol conjugated anti-human IgG	HRP conjugated anti-human IgG
Calibration	Lot specific Master Curve + two
calibrators (Sold separately)	Gliadin IgG II ELISA Low Positive
Gliadin IgG II ELISA High Positive
(Included in the kit)

QUANTA Flash DGP IgA Calibrators

Item	QUANTA Flash DGP IgA Calibrators	Predicate Device
Intended use	For use with the QUANTA Flash DGP
IgA chemiluminescent immunoassay
(CIA). Each calibrator establishes a
point 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.	No separate intended use;
calibrators are part of the kit.
Analyte	DGP IgA antibodies	DGP IgA antibodies
Method	QUANTA Flash™ DGP IgA,
chemiluminescent immunoassay	QUANTA Lite™ Gliadin IgA II, ELISA
Unit	CU (Chemiluminescent units)
(arbitrary)	Units (arbitrary)
Matrix	Human serum, buffer, stabilizers,
preservative	Human serum, buffer, stabilizers,
preservative
Physico-chemical
characteristics	Liquid, ready to use	Liquid, ready to use
Storage	2-8 °C	2-8 °C
Shelf life	One year	One year
In-use stability	Four calibrations, maximum total 8 hours uncapped onboard the instrument.	Calibrators can be used until the end
of the shelf life when stored
properly

QUANTA Flash DGP IgG Calibrators

Item	QUANTA Flash DGP IgG Calibrators	Predicate Device
Intended use	For use with the QUANTA Flash DGP
IgG chemiluminescent immunoassay
(CIA). Each calibrator establishes a
point of reference for the working
curve that is used to determine
Chemiluminescent Unit (CU) values	No separate intended use;
calibrators are part of the kit.

6

| | in the measurement of IgG anti-DGP
antibodies in serum. | |
|-------------------------------------|---------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Analyte | DGP IgG antibodies | DGP IgG antibodies |
| Method | QUANTA Flash™ DGP IgG,
chemiluminescent immunoassay | QUANTA Lite™ Gliadin IgG II, ELISA |
| Matrix | Human serum, buffer, stabilizers,
preservative | Human serum, buffer, stabilizers,
preservative |
| Unit | CU (Chemiluminescent units)
(arbitrary) | Units (arbitrary) |
| Physico-chemical
characteristics | Liquid, ready to use | Liquid, ready to use |
| Storage | 2-8 °C | 2-8 °C |
| Shelf life | One year | One year |
| In-use stability | Four calibrations, maximum total 8
hours uncapped onboard the
instrument. | Calibrators can be used until the end
of the shelf life when stored
properly |

QUANTA Flash DGP IgA Controls

Item	QUANTA Flash DGP IgA Controls	Predicate Device
Intended use	Quality control purposes of the
QUANTA Flash DGP IgA
chemiluminescent immunoassay
(CIA) kit.	No separate intended use; controls
are part of the kit.
Analyte	DGP IgA antibodies	DGP IgA antibodies
Method	QUANTA Flash™ DGP IgA,
chemiluminescent immunoassay	QUANTA Lite™ Gliadin IgA II, ELISA
Unit	CU (Chemiluminescent units)
(arbitrary)	Units (arbitrary)
Matrix	Human serum, buffer, stabilizers,
preservative	Human serum, buffer, stabilizers,
preservative
Physico-chemical
characteristics	Liquid, ready to use	Liquid, ready to use
Levels	2 (negative and positive)	3: (ELISA negative, low positive, high
positive)
Storage	2-8 °C	2-8 °C
Shelf life	One year	One year
In-use stability	15 uses, with a maximum time of 10
minutes onboard the instrument per
use, or 2 ½ hours, total.	Controls can be used until the end
of the shelf life when stored
properly

7

ltem	QUANTA Flash DGP IgG Controls	Predicate Device
Intended use	Quality control purposes of the
QUANTA
Flash
DGP
lgG
chemiluminescent
immunoassay
(CIA) kit.	No separate intended use; controls
are part of the kit.
Analyte	DGP IgG antibodies	DGP IgG antibodies
Method	QUANTA Flash™ DGP IgG,
chemiluminescent immunoassay	QUANTA Lite™ Gliadin IgG II, ELISA
Matrix	Human serum, buffer, stabilizers,
preservative	Human serum, buffer, stabilizers,
preservative
Unit	CU (Chemiluminescent units)
(arbitrary)	Units (arbitray)
Physico-chemical
characteristics	Liquid, ready to use	Liquid, ready to use
Levels	2 (negative and positive)	3: (ELISA negative, low positive, high
positive)
Storage	2-8 °C	2-8 °C
Shelf life	One year	One year
In-use stability	15 uses, with a maximum time of 10
minutes onboard the instrument per
use, or 2 ½ hours, total.	Controls can be used until the end
of the shelf life when stored
properly

Value assignment and traceability of Calibrators and Controls

The QUANTA Flash DGP IgA and IgG Calibrators and Controls are manufactured by diluting human serum that contains high titer of IgA or IgG antibodies into a buffer containing stabilizers and preservative. The human serum is obtained from commercial sources and it is tested for markers of infectious substances.

The target CU is achieved through trial dilutions on small scale. Once a dilution is selected, the Calibrators and Control are bulked, tested, and adjusted. Upon completion of the manufacturing process, the Calibrators and Controls are tested on at least two instruments, on at least two lots of reagent cartridge, in replicates of 10 to determine final value assignment.

There are currently no recognized international standards for the measurement of IgA and IgG antideamidated gliadin peptide antibodies.

Calibrator and Control values are directly traceable to in-house Standards that are used to create the Master Curve for the QUANTA Flash™ DGP IgA and QUANTA Flash™ DGP IgG assay.

Performance characteristics

Precision

The precision of the QUANTA Flash DGP IgA assay was evaluated on 8 samples containing various concentrations of DGP IgA antibodies in accordance with CLSI EPS-A2, Evaluation of Precision Performance of Quantitative Measurement Procedures - Approved Guideline: samples were run in

8

duplicates, twice a day, for at least 20 days. Data were analyzed with the Analyse-it for Excel method evaluation software, and within run, between day and total precisions are summarized in the Table below. All %CV values were within the acceptance limit, 15%.

| | | | Within-Run
Precision
(repeatability) | | Between-Run
Precision | | Between-Day
Precision | | Total Precision | |
|-----------|----|-----------|--------------------------------------------|------|--------------------------|------|--------------------------|-------|-----------------|-------|
| Sample ID | N | Mean(CU)) | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| 1 | 84 | 105.6 | 5.4 | 5.1% | 0.0 | 0.0% | 6.8 | 6.4% | 8.6 | 8.2% |
| 2 | 80 | 35.1 | 2.1 | 5.9% | 0.0 | 0.0% | 3.8 | 10.7% | 4.3 | 12.2% |
| 3 | 84 | 15.4 | 0.9 | 5.8% | 0.0 | 0.0% | 1.0 | 6.2% | 1.3 | 8.5% |
| 4 | 80 | 32.4 | 1.0 | 3.1% | 0.3 | 0.8% | 2.2 | 6.8% | 2.4 | 7.5% |
| 5 | 84 | 128.8 | 5.9 | 4.6% | 4.1 | 3.2% | 8.6 | 6.7% | 11.2 | 8.7% |
| 6 | 84 | 10.5 | 0.4 | 4.0% | 0.2 | 1.9% | 0.6 | 5.8% | 0.8 | 7.3% |
| 7 | 80 | 33.0 | 1.3 | 4.1% | 0.0 | 0.0% | 2.9 | 8.8% | 3.2 | 9.7% |
| 8 | 76 | 1930.8 | 94.9 | 4.9% | 63.8 | 3.3% | 149.7 | 7.8% | 188.4 | 9.8% |

The precision of the QUANTA Flash DGP IgG assay was evaluated on 8 samples containing various concentrations of DGP IgG antibodies in accordance with CLSI EPS-A2, Evaluation of Precision Performance of Quantitative Measurement Procedures - Approved Guideline: samples were run in duplicates, twice a day, for at least 20 days. Data were analyzed with the Analyse-it for Excel method evaluation software, and within run, between run, between day and total precision are summarized in the Table below. All %CV values were within the acceptance limit, 15%.

| | | | Within-Run
Precision
(repeatability) | | Between-Run
Precision | | Between-Day
Precision | | Total Precision | |
|-----------|----|-----------|--------------------------------------------|------|--------------------------|------|--------------------------|------|-----------------|------|
| Sample ID | N | Mean (CU) | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| 1 | 80 | 5.8 | 0.2 | 3.1% | 0.1 | 2.5% | 0.1 | 2.0% | 0.3 | 4.5% |
| 2 | 80 | 16.8 | 0.5 | 3.0% | 0.1 | 0.5% | 0.2 | 1.5% | 0.6 | 3.3% |
| 3 | 80 | 20.7 | 0.5 | 2.5% | 0.3 | 1.3% | 0.5 | 2.2% | 0.7 | 3.6% |
| 4 | 80 | 24.6 | 0.5 | 1.9% | 0.5 | 1.8% | 0.4 | 1.5% | 0.7 | 3.0% |
| 5 | 80 | 85.1 | 1.9 | 2.2% | 0.8 | 0.9% | 2.5 | 2.9% | 3.2 | 3.8% |
| 6 | 80 | 411.6 | 7.7 | 1.9% | 6.8 | 1.6% | 9.4 | 2.3% | 13.9 | 3.4% |
| 7 | 80 | 791.0 | 24.3 | 3.1% | 16.2 | 2.0% | 5.9 | 0.7% | 29.8 | 3.8% |
| 8 | 80 | 1781.4 | 52.1 | 2.9% | 27.9 | 1.6% | 48.3 | 2.7% | 76.3 | 4.3% |

Additionally, precision studies were also performed at three different testing sites to calculate between-sites (between-instruments) precision. Results that were obtained in the research laboratory of INOVA were compared to those obtained on the same specimens in a hospital (Akron City Hospital, Summa Health System, 525 East Market Street, Akron, Ohio 44304) and in an academic laboratory (Mitogen Advanced Diagnostics Laboratory, The University of Calgary, Faculty of Medicine, #431,3330 Hospital Dr NW, Calgary, AB T2N 4N1, CANADA).

9

Three specimens (one negative, one around-the-cutoff low positive and one medium positive) were tested at each site. 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 INOVA site.

Between sites/instruments SD and %CV values were calculated with the Analyse-it for Excel software, and the results are presented below as pair-wise comparisons between the sites.

Moreover, total between-sites reproducibility was calculated based on the pair-wise comparisons, and it was used to calculate Total Reproducibility, taking into account within run, between run, between lots, between calibrator lots, between operators and between sites precision.

Acceptance criterion was ≤ 15% for all reproducibility studies.

DGP IgA, Sample 1

Blue: %CV	Red: average (CU)
	INOVA	Mitogen Advanced
Diagnostics	Summa Health
System
INOVA		12.6	12.6
Mitogen Advanced
Diagnostics	9.1		12.3
Summa Health
System	7.6	5.0

DGP IgA, Sample 2

	Red: average (CU)
	INOVA	Mitogen Advanced Diagnostics	Summa Health System
INOVA		25.4	25.1
Mitogen Advanced Diagnostics	5.4		25.0
Summa Health System	6.6	5.1

DGP IgA, Sample 3

Blue: %CV	Red: average (CU)
	INOVA	Mitogen Advanced
Diagnostics	Summa Health
System
INOVA		137.1	132.8
Mitogen Advanced
Diagnostics	5.7		132.9
Summa Health
System	7.6	6.9

10

DGP IgG, Sample 1

Blue: %CV		Red: average (CU)
	INOVA	Mitogen Advanced
Diagnostics	Summa
Health System
INOVA		13.0	12.8
Mitogen Advanced
Diagnostics	6.3		12.5
Summa Health
System	7.9	5.3

DGP IgG, Sample 2

Blue: %CV Red: average (CU)

	INOVA	Mitogen Advanced Diagnostics	Summa Health Care
INOVA		20.5	20.2
Mitogen Advanced Diagnostics	5.6		19.7
Summa Health Care	7.5	5.2

DGP IgG, Sample 3

Blue: %CV	Red: average (CU)
	INOVA	Mitogen Advanced
Diagnostics	Summa
Health Care
INOVA		118.4	114.1
Mitogen Advanced
Diagnostics	4.7		113.5
Summa Health Care	7.7	7.2

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DGP IgA Total Reproducibility summary table:

			Within Run		Between Run		Between Reagent Lots		Between Calibrator Lots		Between Operators		Between Sites		Total
Sample	Mean (CU)	Number of replicates	SD (CU)	CV (%)	SD (CU)	CV (%)	SD (CU)	CV (%)	SD (CU)	CV (%)	SD (CU)	CV (%)	SD (CU)	CV (%)	SD (CU)	CV (%)
Sample #1	12.9	80	0.8	6.4	0.7	5.2	0.4	3.1	0.7	5.6	0.8	5.8	1.1	9.1	1.9	14.8
Sample #2	25.5	80	1.0	3.8	1.4	5.5	1.1	4.1	1.6	6.3	0.6	2.3	1.8	7.0	3.2	12.6
Sample #3	136.8	80	4.0	2.9	8.9	6.5	7.5	5.5	10.4	7.6	4.4	3.2	11.2	8.3	20.1	14.7

DGP IgG Total Reproducibility summary table:

| | | | Within Run | | Between
Run | | Between
Reagent
Lots | | Between
Calibrator
Lots | | Between
Operators | | Between
Sites | | Total | |
|--------------|--------------|-------------------------|------------|-----------|----------------|-----------|----------------------------|-----------|-------------------------------|-----------|----------------------|-----------|------------------|-----------|------------|-----------|
| Sample | Mean
(CU) | Number of
replicates | SD
(CU) | CV
(%) | SD
(CU) | CV
(%) | SD
(CU) | CV
(%) | SD
(CU) | CV
(%) | SD
(CU) | CV
(%) | SD
(CU) | CV
(%) | SD
(CU) | CV
(%) |
| Sample
#1 | 13.4 | 80 | 0.3 | 2.6 | 0.8 | 5.9 | 0.5 | 4.0 | 1.0 | 7.5 | 0.5 | 3.6 | 1.0 | 8.1 | 1.8 | 13.5 |
| Sample
#2 | 21.0 | 80 | 0.5 | 2.3 | 1.2 | 5.5 | 0.7 | 3.5 | 1.5 | 7.3 | 0.8 | 4.0 | 1.5 | 7.6 | 2.7 | 12.9 |
| Sample
#3 | 118.9 | 80 | 2.8 | 2.4 | 5.9 | 4.9 | 2.8 | 2.3 | 2.8 | 2.3 | 4.7 | 4.0 | 9.4 | 8.1 | 13.0 | 10.9 |

Limit of Blank, Limit of Detection

QUANTA Flash DGP IgA:

The Limit of Detection (LoD) of the QUANTA Flash™ DGP IgA assay is 730.3 RLU, which is below the analytical measuring range of the assay. It was determined consistent with CLSI EP 17-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.

QUANTA Flash DGP IgG:

The Limit of Detection (LoD) of the QUANTA Flash™ DGP IgG assay is 469.2 RLU, 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 de

terminations, with 60 blank and 80 low level samples. The LoB is 257.7 RLU.

12

Analytical Measuring Range

QUANTA Flash DGP IgA:	5.2 CU - 2367.3 CU
QUANTA Flash DGP IgG:	2.8 CU - 1936.7 CU

Cut-off, reference range

QUANTA Flash DGP IgA

The control population for establishing the reference interval for the DGP IgA assay consisted of 355 subjects:

Apparently healthy blood bank donors	201
Inflammatory bowel disease	14
H. pylori infection	9
Autoimmune thyroid disease	18
Infectious diseases	28
Rheumatoid arthritis	30
Patients with antinuclear antibodies	5
Controls tTG workshop study from Dr. Liu at
Children's Hospital and University of Colorado.	50

All specimens were the same matrix (serum) as specified in the Intended Use. All specimens were unaltered. The cut off was established in accordance to CLSI C28-A3c: Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline - Third Edition. The Analyseit for Excel software was used to make the calculations. The distribution of the results was non-normal (Saphiro-Wilk p2367.3 CU for DGP IgA or >1936.7 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 JgA were 11% and 15%, and for the DGP IgG 19% and 5% (within the ± 20% acceptance limit).

High concentration hook effect

To assess hook effect, the measurement signal (relative light units, 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.

Interference

QUANTA Flash DGP IgA:

The interference study was performed according to CLSI EP07-A2, Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition. Three specimens were tested. Interfering substances were spiked into every specimen at three different concentrations in 10% of total specimen volume, and the resulting samples were assessed in triplicates with the DGP IgG assay. Recovery of the unit values was calculated compared to control samples spiked with the same volume of diluents. Acceptance criteria for the interference studies were 85% - 115% recovery, or +/- 4 CU difference, whichever is greater.

No interference was detected with hemoglobin up to 200 mg/dL (recovery 88.9-114.4%) and triglycerides up to 1000 mg/dL and cholesterol up to 224.3 mg/dL (recovery 100.2-110.1%). No interference was detected with bilirubin up to 10 mg/dL (recovery: 96.0-114.6%) in two specimens. One specimen showed 116.1% recovery when spiked with 5 mg/dl bilirubin; however, no interference could be detected when the same specimen was spiked with 10 mg/dL bilirubin (recovery 109.9%) or when the other specimens were spiked with the same concentration of bilirubin. No interference was detected with RF IgM up to 500 IU/mL (recovery 86.8-98.5%). One specimen showed 76.3% recovery when spiked with 500 IU/mL RF; however, no interference was detected when the same specimen was spiked with 100 and 300 IU/mL RF (recovery 94.1 and 98.5%), or when the other two specimens were spiked with 500 IU/mL.

15

QUANTA Flash DGP IgG:

The interference study was performed according to CLSI EPO7-A2, Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition. Five specimens were tested. One specimen (6.2 CU) was excluded from the final calculations, as some of the measurement results were below the analytical measuring range (5.2 CU). Interfering substances were spiked into every specimen at three different concentrations in 10% of total specimen volume, and the resulting samples were assessed in triplicates with the DGP IgG assay. Recovery of the unit values was calculated compared to control samples spiked with the same volume of diluents. Acceptance criteria for the interference studies were 85% - 115% recovery, or +/- 4 CU difference, whichever is greater.

No interference was detected with bilirubin up to 10 mg/dL (recovery: 104-108%), hemoglobin up to 200 mg/dL (recovery 100-110%), triglycerides up to 1000 mg/dL (recovery 104-107%), and cholesterol up to 224.3 mg/dL (recovery 104-107%). No interference was detected with RF IgM up to 500 IU/mL in three specimens (recovery 99-112%). One specimen showed 137% recovery when spiked with 100 IU/mL RF only; however, no interference was detected when the same specimen was spiked with 300 and 500 IU/mL RF (recovery 108% and 112%), or when the other three specimens were spiked with the same concentration of RF.

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 and connective tissue diseases, including those characterized with gastrointestinal symptoms. None of those specimens were positive in the DGP IgA test.

QUANTA Flash DGP IgG:

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

Comparison with predicate device

QUANTA Flash DGP IgA:

Samples for method comparison analysis included those samples from the clinical validation studies (CD, non-CD and dermatitis herpetiformis patients) that were within the AMR of the QUANTA Flash DGP IgA assay. These samples were tested on both the QUANTA Flash DGP IgA and on the predicate ELISA.

16

Method Comparison (N=96)		DGP IgA ELISA			Percent Agreement
		Positive	Negative	Total	(95% Confidence)
QUANTA
Flash™ DGP
IgA CIA	Positive	65	3*	68	Pos. Agreement = 91.5% (82.5-96.8%)
	Negative	6**	28	34	Neg. Agreement = 90.3% (74.2-98.0%)
	Total	71	31	102	Total Agreement = 91.2% (83.9-95.9%)

Two patients are suspected CD with no diagnosis, while the third is a DH patient.

** Two patients have DH. Three patients have CD, two without clinical presentation, one with a Marsh III biopsy. One patient has ulcerative colitis.

DGP IgA method comparison on DH samples:

Method Comparison (N=21)		DGP IgA ELISA			Percent Agreement
		Positive	Negative	Total	(95% Confidence)
QUANTA
Flash™ DGP
IgA CIA	Positive	12	1	13	Pos. Agreement = 85.7% (57.2%-98.2%)
	Negative	2	6	8	Neg. Agreement = 85.7% (42.1-99.6%)
	Total	14	7	21	Total Agreement = 85.7% (63.7%-97.0%)

QUANTA Flash DGP IgG:

Samples for method comparison analysis included those samples from the clinical validation studies (CD, non-CD and DH patients) that were within the AMR of the QUANTA Flash DGP IgG assay. These samples were tested on both the QUANTA Flash DGP IgG and on the predicate ELISA.

Method Comparison (N=235)		DGP IgG ELISA			Percent Agreement
		Positive	Negative	Total	(95% Confidence)
QUANTA
Flash™ DGP
IgG CIA	Positive	78	26*	104	Pos. Agreement = 95.1% (88.0-98.7%)
	Negative	4**	133	137	Neg. Agreement = 83.6% (77.0-89.0%)
	Total	82	159	241	Total Agreement = 87.6% (82.7-91.4%)

17

*Thirteen samples are from CD patients; three being on GFD. One sample is from a suspected CD patient that is IgA anti-DGP positive. Two samples have H. pylori gastrits, two have viral hepatitis, and one has rheumatoid arthritis. One patient, with low blood count, is lgG anti-h-tTG positive. The remaining 6 samples are from apparently healthy individuals; one had gastrointestinal symptoms at time of sample collection, with two being IgA anti-h-tTG positive.

** Three samples are from CD patients, and one is from a DH patient.

DGP IgG method comparison on DH samples:

Method Comparison (N=21)		DGP IgG ELISA			Percent Agreement
		Positive	Negative	Total	(95% Confidence)
QUANTA
Flash™ DGP
IgG CIA	Positive	16	0	16	Pos. Agreement = 88.9% (65.3%-98.6%)
	Negative	2	5	7	Neg. Agreement = 100.0% (47.8%-100.0%)
	Total	18	5	23	Total Agreement = 91.3% (72.0%-98.9%)

DGP IgG method comparison on IgA deficient samples:

Method Comparison (N=21)		DGP IgG ELISA			Percent Agreement
		Positive	Negative	Total	(95% Confidence)
QUANTA
Flash™ DGP
IgG CIA	Positive	5	2	7	Pos. Agreement = 71.4% (29.0%-96.3%)
	Negative	2	4	6	Neg. Agreement = 66.7% (22.3%-95.7%)
	Total	7	6	13	Total Agreement = 69.2% (38.6%-90.9%)

Clinical sensitivity, specificity

QUANTA Flash DGP IgA:

The clinical validation study included 54 CD samples from library, 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 from individuals seeking medical attention in whom CD was excluded based on physical exam and diagnostic tests, and 98 disease controls. The 151 samples consisted of 58 samples from adults and 93 samples from pediatric population. Clinical symptoms of these subjects were consistent with suspected CD:

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gastrointestinal symptoms, fatigue, and/or anemia. These samples were tested with the QUANTA Flash DGP IgA CIA. Results obtained on healthy blood donors were not included in the clinical sensitivity and specificity calculations. None of the control samples were positive in the DGP IgA assay.

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).

When divided according to age, the QUANTA Flash™ DGP IgA test was performed on 43 serum samples from infants, 96 serum samples from children, 36 serum samples from adolescents, and 324 serum samples from adults. Sera from all pediatric groups showed similar sensitivity and specificity values as of the adult population, thereby demonstrating the utility of the same cut-off (20 CU). The results of this testing are shown in the Tables below:

Clinical sensitivity and specificity of the QUANTA FlashTM - DGP IgA assay in CD
		Diagnosis			Analysis
		CD	Not CD	Total	(95% confidence)
QUANTA FlashTM
DGP IgA	Positive	105	0	105	Sensitivity = 71.4% (63.4-78.6%)
	Negative	42*	352	394	Specificity = 100.0% (99.0-100%)
	Total	147	352	499
*Of 21 patients with ELISA data, 18 were DGP IgA EIA negative. Of the 21 patients with no ELISA data, 6 had Marsh III, 4 had Marsh II, and 11 had no biopsy result.

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

The distribution and DGP IgA positivity rate in the disease control population:

Patient Group	N	# of positives
Autoimmune liver disease	5	0
Viral hepatitis	47	0
Inflammatory bowel disease (Chron +UC)	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
Rheumatoid arthritis	37	0
Other infectious disease (HIV, Syphilis)	10	0
Total	201	0

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Summary of sensitivity and specificity values in CD according to age groups:

Age group	DGP IgA
	Sensitivity, %	Specificity, %
1 month – 2 years	50.0	100.0
2 years - 12 years	66.7	100.0
12-21 years	58.3	100.0
>21 years	77.4	100.0
21 years	89.4	97.8