(256 days)
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No
The description details a standard ELISA immunoassay with spectrophotometric reading and calculation of results based on established thresholds, with no mention of AI/ML algorithms for data analysis or interpretation.
No
This device is an in vitro diagnostic (IVD) test intended to aid in the diagnosis of celiac disease or dermatitis herpetiformis by detecting specific antibodies. It does not directly treat or prevent a disease, which is the primary function of a therapeutic device.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "to aid in the diagnosis of patients with celiac disease or dermatitis herpetiformis." This indicates its purpose is diagnostic support.
No
The device description clearly outlines a solid phase immunoassay involving physical components like microwells, antigens, conjugates, and substrates, which are processed and read by a spectrophotometer. This indicates a hardware-based in vitro diagnostic device, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the device is for the "qualitative detection of IgA anti-gliadin antibodies in human serum" and "qualitative detection of IgG anti-gliadin antibodies in human serum". This indicates the device is used to examine specimens derived from the human body.
- Purpose: The purpose is "to aid in the diagnosis of patients with celiac disease or dermatitis herpetiformis in conjunction with other laboratory and clinical findings". This clearly shows the device is intended for use in the diagnosis of disease.
- Device Description: The description details a laboratory test method (ELISA) performed on human serum samples.
- Performance Studies: The document includes detailed descriptions of non-clinical and clinical studies performed on human samples to evaluate the device's performance in detecting the target antibodies.
- Key Metrics: The document provides key metrics like Sensitivity and Specificity, which are standard performance indicators for diagnostic tests.
- Predicate Device(s): The mention of predicate devices that are also ELISAs for detecting gliadin antibodies further supports its classification as an IVD.
All these elements align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens, including blood, tissues, and body excretions, from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
N/A
Intended Use / Indications for Use
Enzyme linked immunosorbent assays (ELISA) for the qualitative detection of IgA anti-gliadin antibodies in human serum to aid in the diagnosis of patients with celiac disease or dermatitis herpetiformis in conjunction with other laboratory and clinical findings
Enzyme linked immunosorbent assays (ELISA) for the qualitative detection of IgG anti-gliadin antibodies in human serum to aid in the diagnosis of patients with celiac disease or dermatitis herpetiformis in conjunction with other laboratory and clinical findings
Enzyme inked immunosorbent assays (EUSA) for the qualitative detection of IgA or IgG anti-gliadin antibodies in human serum to aid in the diagnosis of patients with celiac disease or dermotitis herpetiformis in conjunction with other laboratory and clinical findings.
Product codes
MST
Device Description
This test is performed as a solid phase immunoassay. Microwells are coated with antigen. Controls, calibrators and patient sera are incubated in the antigen coated wells to allow specific antibodies present in the serum to bind to the gliadin antigen. Bound antibodies are detected by adding an enzyme labeled anti-human IgA or IgG conjugate. Specific enzyme substrate (TMB) is then added and the presence of antibodies is detected by a color change that is read by a spectrophotometer at 450 mm. Results are expressed in ELISA units per milliliter (EU/ml) and reported as positive or negative.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Cross Reactivity: A total of 456 sera from individuals with other potentially cross-reactive autoimmune disorders were selected to test for gliadin antibodies using the ImmuLisa™ assay. The results appear below.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Tests:
Method Comparison: Both kits were tested with well-characterized CD and DH subjects and disease controls.
Disease Associated Specimens: 230
Disease Control Specimens: 170
Borderline considered positive
Positive % Agreement 97.2% (95% CI 91.6% - 99.3%)
Negative % Agreement 90.0% (95% CI 85.9% - 93.1%)
Overall % Agreement 92.0% (95% CI 88.9% - 94.3%)
Borderline considered negative
Positive % Agreement 88.1% (95% CI 80.1% - 93.2%)
Negative % Agreement 94.2% (95% CI 90.6% - 96.5%)
Overall % Agreement 92.5% (95% CI 89.5% - 94.7%)
Predicate AGA IgG
Disease Associated Specimens: 246
Disease Control Specimens: 213
Borderline considered positive
Positive % Agreement 97.1% (95% CI 93.4% - 98.8%)
Negative % Agreement 94.5% (95% CI 90.7% - 96.8%)
Overall % Agreement 95.6% (95% CI 93.4% - 97.2%)
Borderline considered negative
Positive % Agreement 92.7% (95% CI 88.0% - 95.7%)
Negative % Agreement 96.1% (95% CI 92.7% - 98.0%)
Overall % Agreement 94.6% (95% CI 92.1% - 96.3%)
Cross Reactivity: A total of 456 sera from individuals with other potentially cross-reactive autoimmune disorders were selected to test for gliadin antibodies using the ImmuLisa™ assay.
Precision: Seven patients were run in duplicate, twice per day for 20 days (n=80 replicates per sample). Assays were run by two operators on two different sets of equipment.
Qualitative Reproducibility: 80 replicates of samples in the low negative range, near the cutoff, in the moderate positive range, and approximately +/- 20% of the assay cutoffs for each AGA isotype were performed to determine qualitative reproducibility. One sample near the cutoff yielded 51.3% and 57.5% agreement on Gliadin IgA and Gliadin IgG respectively, all remaining specimens produced 100% qualitative agreement.
Inter-lot Reproducibility: Five samples were tested in replicates of five on three separate assay lots for 5 days. There was no recalibration of this equipment over the course of this study.
Inter-site Reproducibility: Site to site reproducibility was tested with multiple endogenous specimens selected throughout the ranges were tested in replicates of 5 in three different sites over the days. There was no recalibration of this equipment over the course of this study.
Limit of Detection / Limit of Blank / Limit of Quantitation: The limits of blank (LoB) and limits of detection (LoD) were determined based on 60 replicates of the blank and 10 replicates each of 6 low-level (NHS) samples. LoB was determined to be 2.2 EU/ml for IgG. LoD was determined to be 3.6 EU/ml for IgA and 2.8 EU/ml for IgG. The limits of quantitation (LoQ) were determined by testing four low level samples in replicates of four. LoQ was determined to be 7.5 EU/ml for IgA and 4.6 EU/ml for IgG.
Linearity and Recovery: Linearity and recovery were tested by diluting positive specimens through the assay range in equidistant dilutions and comparing actual vs. expected results. The linear range of the assay was determined be 7.5 (LoQ) – 160 EU/ml for IgA. Hook effect was not demonstrated in dilution samples as high as ~5,515.8 EU/ml for IgG within OD range of the microplate reader (~3.50D).
Interference: No significant interference was demonstrated for the following substances at the levels indicated: Hemoglobin (2 g/L), Bilirubin (342 µmol/L), Rheumatoid Factor (100 EU/ml), Triglycerides (37 mmol/L), and Cholesterol (13 mmol/L).
Clinical Study: Sets of clinical samples were tested on the IMMCO Enhanced Gliadin ELISAs. By testing 250 celiac disease and 45 dermatitis herpetiformis along with 456 autoimmune and infectious disease controls following sensitivity and specificity were calculated. IgA deficient CD have been excluded from these calculations.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Clinical Study:
Borderline / indeterminate results are considered positive:
Celiac Disease:
IgA Sensitivity: 65.6% (95% CI 59.3% - 71.4%)
IgA Specificity: 97.4% (95% CI 95.3% - 98.6%)
IgG Sensitivity: 76.4% (95% CI 70.5% - 81.4%)
IgG Specificity: 95.4% (95% CI 92.9% - 97.1%)
Dermatitis herpetiformis:
IgA Sensitivity: 35.6% (95% CI 22.3% - 51.3%)
IgA Specificity: 97.4% (95% CI 95.3% - 98.6%)
IgG Sensitivity: 57.8% (95% CI 42.2% - 72.0%)
IgG Specificity: 95.4% (95% CI 92.9% - 97.1%)
Borderline / indeterminate results are considered negative:
Celiac Disease:
IgA Sensitivity: 55.6% (95% CI 49.2% - 61.8%)
IgA Specificity: 98.5% (95% CI 96.7% - 99.3%)
IgG Sensitivity: 68.4% (95% CI 62.2% - 74.0%)
IgG Specificity: 96.7% (95% CI 94.5% - 98.1%)
Dermatitis herpetiformis:
IgA Sensitivity: 33.3% (95% CI 20.4% - 49.1%)
IgA Specificity: 98.5% (95% CI 96.7% - 99.3%)
IgG Sensitivity: 55.6% (95% CI 40.1% - 70.0%)
IgG Specificity: 96.7% (95% CI 94.5% - 98.1%)
Predicate Device(s)
IMMCO Gliadin (AGA) IgA ELISA, IMMCO Gliadin (AGA) IgG ELISA
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/12 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure in profile, with three overlapping figures suggesting community or support.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 28, 2017
Immco Diagnostics, Inc. Kevin Lawson VP Regulatory Affairs 9870 Hollingson Rd Clarence, New York 14031
Re: K163177
Trade/Device Name: ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA Regulation Number: 21 CFR 866.5750 Regulation Name: Radioallergosorbent (RAST) immunological test system Regulatory Class: Class II Product Code: MST Dated: July 5, 2017 Received: July 7, 2017
Dear Kevin Lawson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
1
Part 807): labeling (21 CFR Part 801 and Part 809): medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Kelly Oliner -S
For Leonthena R. Carrington, M.S., MBA, MT Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K163177
Device Name ImmuLisa™ Enhanced Gliadin IgA Antibody ELISA
ImmuLisa™ Enhanced Gliadin IgG Antibody ELISA
Indications for Use (Describe)
Enzyme linked immunosorbent assays (ELISA) for the qualitative detection of IgA anti-gliadin antibodies in human serum to aid in the diagnosis of patients with celiac disease or dermatitis herpetiformis in conjunction with other laboratory and clinical findings
Enzyme linked immunosorbent assays (ELISA) for the qualitative detection of IgG anti-gliadin antibodies in human serum to aid in the diagnosis of patients with celiac disease or dermatitis herpetiformis in conjunction with other laboratory and clinical findings
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | ☒ |
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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Image /page/3/Picture/0 description: The image shows the logo for Immco Diagnostics. The logo features a cluster of blue and green circles on the left, followed by the word "immco" in blue, with a small dot above the "o". Below "immco" is the word "DIAGNOSTICS" in green, and below that is the text "A Trinity Biotech Company" in a smaller font.
510(k) Summary
| Submitter: | Immco Diagnostics, Inc. |
|---|---|
| Address: | 60 Pineview Dr., Buffalo, NY 14228 |
| Phone Number: | 716-691-0091 ext. 110 |
| Contact: | Kevin Lawson |
| Summary Prepared: | 7-27-2017 |
| Device Name: | ImmuLisa™ Enhanced Gliadin IgA Antibody ELISA |
| ImmuLisa™ Enhanced Gliadin IgG Antibody ELISA | |
| Common Name: | Anti-Gliadin IgA or IgG Antibody (AGA) ELISA |
| Product Code: | Antibodies, Gliadin [MST] |
| Substantially Equivalent to: | IMMCO Gliadin (AGA) IgA ELISA |
| IMMCO Gliadin (AGA) IgG ELISA |
General Description: Celiac Disease (CD) and dermatitis herpetiformis (DH) are autoimmune gastrointestinal and skin disorders that may occur in genetically susceptible individuals triggered by the ingestion of gluten containing grains such as wheat, barley and rye. The classical symptoms of CD include diarhea, weight loss and malnutrition. Dermatitis herpetiformis is chronic bullous disease characterized by the formation of subepidermal blisters. Only a small percent with CD present with classical symptoms. The most common serologic tests for the screening of CD or DH are the immunofluorescence method of detecting endomysial antibodies (EMA) and ELISA methods of detecting antibodies to tissue transglutaninase (tTG) and gliadin. The EMA and tTG immunoassays is that both immunoassays detect IgA antibodies, hindering identification of IgA deficient patients with CD. IgG gliadin antibody tests are important towards the diagnosis of CD in patient. Studies show that 1-2% of the general population is lgA deficient and that the incidence of CD in lgA deficient, hence the need for specific tests. In addition to the native Gliadin assay, Gliadin peptide based assys have shown promising results in addressing the limitations of current immunoassay for gliadin antibodies incorporates a native gliadin for sensitive and specific detection of IgA or IgG isotype antibodies with a high degree of reliability.
This test is performed as a solid phase immunoassay. Microwells are coated with antigen. Controls, calibrators and patient sera are incubated in the antigen coated wells to allow specific antibodies present in the serum to bind to the gliadin antigen. Bound antibodies are detected by adding an enzyme labeled anti-human IgA or IgG conjugate. Specific enzyme substrate (TMB) is then added and the presence of antibodies is detected by a color change that is read by a spectrophotometer at 450 mm. Results are expressed in ELISA units per milliliter (EU/ml) and reported as positive or negative.
Intended Use: Enzyme inked immunosorbent assays (EUSA) for the qualitative detection of IgA or IgG anti-gliadin antibodies in human serum to aid in the diagnosis of patients with celiac disease or dermotitis herpetiformis in conjunction with other laboratory and clinical findings.
Similarities and Differences: Both kits use native purified Gliadin coated on 96 well plates to detect IgA or IgG Gliadin antibodies with anti-human IgA or IgG conjugate and substrate. Both kits test human serum. Semi-quantitative results are reported in EU/ml for both kits. The Enhanced kit utilizes a HRP anti-human lgA or lgG conjugate and TMB substrate, while the predicate and aline phosphatase IgA or IgG conjugate and pNPP substrate. The Enhanced kit utilizes a 5 point calibrator curve with a borderline / indeterminate range of 20-25 EU/ml while the predicate AGA kit uses a 4 point calibrator curve with a cutoff of 20 units and no borderline range.
Non-clinical Tests:
Method Comparison: Both kits were tested with well-characterized CD and DH subjects and disease controls.
| Predicate AGA IgA | ||||
|---|---|---|---|---|
| Pos | Neg | Total | ||
| Immco | Pos | 96 | 17 | 113 |
| AGA IgA | Borderline | 10 | 12 | 22 |
| ELISA | Neg | 3 | 262 | 265 |
| Total | 109 | 291 | 400 |
60 Pineview Drive Buffalo, NY 14228-2120 USA 537-8378
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Image /page/4/Picture/0 description: The image shows the logo for Immco Diagnostics. The logo features a cluster of blue and green circles on the left side, followed by the word "immco" in blue. Below "immco" is the word "DIAGNOSTICS" in green. The logo is clean and modern, with a focus on the company's name and area of expertise.
Trinity Biotech Comna
| Disease Associated Specimens: 230 | |||||
|---|---|---|---|---|---|
| Disease Control Specimens: 170 | |||||
| Borderline considered positive | |||||
| Positive % Agreement | 97.2% | (95% CI 91.6% - 99.3%) | |||
| Negative % Agreement | 90.0% | (95% CI 85.9% - 93.1%) | |||
| Overall % Agreement | 92.0% | (95% CI 88.9% - 94.3%) | |||
| Borderline considered negative | |||||
| Positive % Agreement | 88.1% | (95% CI 80.1% - 93.2%) | |||
| Negative % Agreement | 94.2% | (95% CI 90.6% - 96.5%) | |||
| Overall % Agreement | 92.5% | (95% CI 89.5% - 94.7%) | |||
| Predicate AGA IgG | |||||
| Pos | Neg | Total | |||
| Immco | Pos | 190 | 10 | 200 | |
| AGA IgG | Borderline | 9 | 4 | 213 | |
| ELISA | Neg | 6 | 240 | 246 | |
| Total | 205 | 254 | 459 | ||
| Disease Associated Specimens: 246 | |||||
| Disease Control Specimens: 213 | |||||
| Borderline considered positive | |||||
| Positive % Agreement | 97.1% | (95% CI 93.4% - 98.8%) | |||
| Negative % Agreement | 94.5% | (95% CI 90.7% - 96.8%) | |||
| Overall % Agreement | 95.6% | (95% CI 93.4% - 97.2%) | |||
| Borderline considered negative | |||||
| Positive % Agreement | 92.7% | (95% CI 88.0% - 95.7%) | |||
| Negative % Agreement | 96.1% | (95% CI 92.7% - 98.0%) | |||
| Overall % Agreement | 94.6% | (95% CI 92.1% - 96.3%) |
Cross Reactivity: A total of 456 sera from individuals with other potentially cross-reactive autoimmune disorders were selected to test for gliadin antibodies using the ImmuLisa™ assay. The results appear below.
| Gliadin IgA | Gliadin IgG | |||||
|---|---|---|---|---|---|---|
| Disease | n | n Pos | % Pos | n Pos | % Pos | |
| Rheumatoid Arthritis | 30 | 1 | 3.3% | 0 | 0.0% | |
| Graves' disease | 15 | 1 | 6.7% | 0 | 0.0% | |
| Hashimoto's thyroiditis | 15 | 0 | 0.0% | 1 | 6.7% | |
| Systemic lupus erythematosus | 30 | 2 | 6.7% | 3 | 10.0% | |
| Granulomatosis with polyangiitis | 30 | 0 | 0.0% | 1 | 3.3% | |
| Systemic sclerosis | 30 | 0 | 0.0% | 0 | 0.0% | |
| Ulcerative Colitis | 25 | 0 | 0.0% | 1 | 4.0% | |
| Crohn's disease | 25 | 1 | 4.0% | 2 | 8.0% | |
| Rubella | 20 | 0 | 0.0% | 0 | 0.0% | |
| Herpes simplex virus Type 1 | 20 | 0 | 0.0% | 0 | 0.0% | |
| Herpes simplex virus Type 2 | 20 | 0 | 0.0% | 3 | 15.0% | |
| Cytomegalovirus | 20 | 0 | 0.0% | 0 | 0.0% | |
| Toxoplasmosis | 20 | 0 | 0.0% | 0 | 0.0% | |
| Lyme disease | 36 | 0 | 0.0% | 3 | 8.3% | |
| Autoimmune hepatitis | 30 | 0 | 0.0% | 1 | 3.3% | |
| Primary biliary cirrhosis | 50 | 4 | 8.0% | 3 | 6.0% | |
| Helicobacter pylori | 40 | 3 | 7.5% | 3 | 7.5% | |
| Total | 456 | 12 | 2.6% | 21 | 4.6% |
60 Pineview Drive ● Buffalo, NY 14228-2120 ● Toll free (800) 537-8378 ● tel. (716) 691-0091 ●
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Image /page/5/Picture/0 description: The image shows the logo for Immco Diagnostics. The logo features a cluster of blue and green dots on the left, followed by the word "immco" in blue, with a small dot above the "o". Below "immco" is the word "DIAGNOSTICS" in green. Underneath that, it says "A Trinity Biotech Company" in a smaller font.
Precision
Precision was tested with positive specimens selected throughout the range of the assay. Seven patients were run in duplicate, twice per day for 20 days (n=80 replicates per sample). Assays were run by two operators on two different sets of equipment.
Gliadin IgA
| | Mean | Total
Imprecision | | Within run
(Repeatability) | | Between days | | Between Runs | |
|----|-------|----------------------|------|-------------------------------|-----|--------------|-----|--------------|-----|
| S# | EU/ml | SD | CV% | SD | CV% | SD | CV% | SD | CV% |
| 1 | 3.6 | 0.4 | 10.3 | 0.4 | 9.9 | 0.2 | 6.6 | 0.1 | 3.1 |
| 2 | 15.3 | 0.9 | 5.6 | 0.8 | 5.3 | 0.6 | 3.8 | 0.3 | 7.1 |
| 3 | 20.2 | 0.9 | 4.5 | 0.8 | 4.0 | 0.8 | 3.9 | 0.4 | 2.1 |
| 4 | 23.7 | 1.4 | 5.7 | 1.0 | 4.1 | 0.8 | 3.3 | 0.9 | 3.9 |
| 5 | 67.9 | 2.2 | 3.2 | 1.8 | 2.6 | 1.3 | 1.9 | 1.3 | 1.9 |
| 6 | 93.2 | 5.6 | 5.7 | 4.9 | 5.2 | 4.8 | 5.1 | 2.1 | 2.2 |
| 7 | 143.5 | 11.0 | 7.1 | 9.3 | 6.4 | 10.3 | 7.2 | 4.4 | 3.1 |
Gliadin IgG
| | Mean | Total
Imprecision | | Within run
(Repeatability) | | Between days | | Between Runs | |
|----|-------|----------------------|-----|-------------------------------|-----|--------------|-----|--------------|-----|
| S# | EU/ml | SD | CV% | SD | CV% | SD | CV% | SD | CV% |
| 1 | 13.7 | 1.4 | 9.9 | 0.6 | 4.1 | 0.6 | 4.2 | 1.1 | 8.0 |
| 2 | 17.4 | 1.1 | 6.5 | 0.6 | 3.3 | 0.3 | 1.8 | 0.9 | 5.4 |
| 3 | 19.9 | 1.2 | 5.9 | 0.7 | 3.3 | 0.7 | 3.2 | 0.7 | 3.6 |
| 4 | 23.4 | 1.2 | 5.3 | 0.7 | 2.8 | 0.5 | 2.2 | 1.0 | 4.4 |
| 5 | 44.8 | 2.5 | 5.5 | 1.8 | 4.0 | 0.7 | 1.6 | 1.6 | 3.5 |
| 6 | 96.8 | 8.5 | 8.8 | 3.5 | 3.6 | 1.7 | 1.7 | 7.6 | 7.8 |
| 7 | 153.4 | 13.4 | 8.7 | 6.6 | 4.3 | 5.1 | 3.3 | 11.6 | 7.6 |
Qualitative Reproducibility
80 replicates of samples in the low negative range, near the cutoff, in the moderate positive range, and approximately +/- 20% of the assay cutoffs for each AGA isotype were performed to deternine qualitative reproducibility. One sample near the cutoff yielded 51.3% and 57.5% agreement on Gliadin IgA and Gliadin IgG respectively, all remaining specimens produced 100% qualitative agreement.
Inter-lot Reproducibility
Inter-lot reproducibility was tested with multiple endogenous specimens selected throughout the range of the samples were tested in replicates of 5 on three different lots over the cays. There was no recalibration of this equipment over the course of this study. Five samples were tested in replicates of five on three separate assay lots for 5 days.
| Gliadin IgA | ||||||
|---|---|---|---|---|---|---|
| Repeatability | Within Lot | Reproducibility | ||||
| Mean | SD | CV | SD | CV | SD | CV |
| 9.87 | 0.36 | 3.7% | 0.74 | 7.5% | 0.74 | 7.5% |
| 22.56 | 1.36 | 6.0% | 1.70 | 7.5% | 1.78 | 7.9% |
| 35.19 | 0.81 | 2.3% | 2.36 | 6.7% | 2.36 | 6.7% |
| 77.90 | 1.60 | 2.1% | 5.72 | 7.3% | 5.88 | 7.6% |
| 149.72 | 6.62 | 4.4% | 10.74 | 7.2% | 11.65 | 7.8% |
Gliadin IgG
| Repeatability | Within Lot | Reproducibility | ||||
|---|---|---|---|---|---|---|
| Mean | SD | CV | SD | CV | SD | CV |
| 16.13 | 0.59 | 3.7% | 1.49 | 9.2% | 1.49 | 9.2% |
| 22.59 | 1.01 | 4.5% | 2.06 | 9.1% | 2.06 | 9.1% |
| 35.48 | 1.18 | 3.3% | 3.10 | 8.7% | 3.10 | 8.7% |
| 87.31 | 2.69 | 3.1% | 5.37 | 6.2% | 5.66 | 6.5% |
| 122.87 | 4.97 | 4.0% | 9.99 | 8.1% | 11.29 | 9.2% |
Inter-site Reproducibility
Site to site reproducibility was tested with multiple endogenous specimens selected throughout the ranges were tested in replicates of 5 in three different sites over the cays. There was no recalbration of this equipment over the course of this study.
60 Pineview Drive 0 Buffalo. NY 14228-2120 USA Toll free (800) 537-8378 · · tel. (716) 691-0091 · · fax (716) 691-0466
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Image /page/6/Picture/0 description: The image shows the logo for Immco Diagnostics. The logo features a cluster of blue and green circles on the left, followed by the word "immco" in blue, with the word "DIAGNOSTICS" in green underneath. Below that, the words "A Trinity Biotech Company" are written in a smaller font.
Gliadin IgA
| Mean | Repeatability | Within Lot | Reproducibility | ||||
|---|---|---|---|---|---|---|---|
| SD | CV | SD | CV | SD | CV | ||
| 10.00 | 0.44 | 4.4% | 0.76 | 7.6% | 0.83 | 8.3% | |
| 22.73 | 0.60 | 2.7% | 1.40 | 6.2% | 2.13 | 9.4% | |
| 47.72 | 1.36 | 2.9% | 2.87 | 6.0% | 4.10 | 8.6% | |
| 88.38 | 4.70 | 5.3% | 7.79 | 8.8% | 8.46 | 9.6% | |
| 146.18 | 5.09 | 3.5% | 11.99 | 8.2% | 12.79 | 8.8% |
| Gliadin IgG | ||||||
|---|---|---|---|---|---|---|
| Mean | Repeatability | Within Lot | Reproducibility | |||
| SD | CV | SD | CV | SD | CV | |
| 13.99 | 0.71 | 5.1% | 0.89 | 6.4% | 1.28 | 9.1% |
| 24.12 | 0.97 | 4.0% | 1.91 | 7.9% | 2.06 | 8.5% |
| 33.88 | 1.35 | 4.0% | 2.36 | 7.0% | 2.36 | 7.0% |
| 69.97 | 2.85 | 4.1% | 5.11 | 7.3% | 5.77 | 8.2% |
| 151.12 | 5.27 | 3.5% | 10.82 | 7.2% | 13.95 | 9.2% |
Limit of Detection / Limit of Blank / Limit of Quantitation
The limits of blank (LoB) and limits of determined based on 60 replicates of the blank and 10 replicates each of 6 lowlevel (NHS) samples. LoB was determined to be 2.2 EU/ml for IgG. LoD was determined to be 3.6 EU/ml for lgA and 2.8 EU/ml for !gG. The limits of quantitation (LoQ) were determined by testing four low level samples in replicates of four. LoQ was determined to be 7.5 EU/ml for IgA and 4.6 EU/ml for IgG.
Linearity and Recovery
Linearity and recovery were tested by diluting positive specimens through the assay range in equidistant dilutions and comparing actual vs. expected results. The linear range of the assay was determined be 7.5 (LoQ) – 160 EU/ml for lgA Results are summarized below.
| IgA | Test Range
(EU/ml) | Slope (95% CI) | Y-intercept
(95% CI) | R2 | % Recovery
(Obtnd/Expctd) |
|-----|-----------------------|---------------------|-------------------------|--------|------------------------------|
| | 7.4 to 41.6 | 1.01 (.92 to 1.10) | 1.13 (-1.14 to 3.39) | 0.9942 | 92% to 94% |
| | 2.3 to 97.2 | 1.04 (0.95 to 1.12) | 1.45 (-3.18 to 6.08) | 0.9935 | 90% to 96% |
| | 4.7 to 127.4 | 0.85 (0.79 to 0.91) | 2.06 (-3.39 to 7.41) | 0.9986 | 102% to 117% |
| IgG | Test Range
(EU/ml) | Slope (95% CI) | Y-intercept
(95% CI) | R2 | % Recovery
(Obtnd/Expctd) |
| | 9.0 to 47.0 | 0.98 (0.88 to 1.08) | 0.87 (-2.16 to 3.90) | 0.9923 | 93% to 106% |
| | 12.7 to 116.8 | 0.98 (0.91 to 1.05) | -1.47 (-6.66 to 3.73) | 0.9951 | 102% to 110% |
| | 58.1 to 147.4 | 0.98 (0.87 to 1.08) | 3.67 (-7.70 to 15.04) | 0.9938 | 98% to 106% |
To assess hook effect, dilutions of high positive specimens with results above the 160 EU/ml measuring ranges were tested. Hook effect was not demonstrated in dilution samples as high as ~5,515.8 EU/ml for lgG within OD range of the microplate reader (~3.50D).
Interference
Interference was studied by mixing sera with known gliading with potentially interfering serum samples and studying deviation from expected results. No significant interference was demonstrated for the following substances at the levels indicated: Hemoglobin (2 g/L), Bilirubin (342 µmo/L), Rheumatoid Factor (100 EU/ml), Triglycerides (37 mmo/L), and Cholesterol (13 mmo/L).
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Image /page/7/Picture/0 description: The image shows the logo for Immco Diagnostics. The logo features a cluster of blue and green dots on the left, followed by the word "immco" in blue, with a green dot above the "o". Below "immco" is the word "DIAGNOSTICS" in green. Underneath that is the text "A Trinity Biotech Company".
Clinical Study: Sets of clinical samples were tested on the IMMCO Enhanced Gliadin ELISAs. By testing 250 celiac disease and 45 dermatits herpetiformis along with 456 autoimmune and infectious disease controls following sensitivity and specificity were calculated. IgA deficient CD have been excluded from these calculations.
96.7% (95% Cl 94.5% - 98.1%)
Borderline / indeterminate results are considered positive:
| Celiac Disease | IgA | IgG | |
|---|---|---|---|
| Sensitivity | 65.6% (95% CI 59.3% - 71.4%) | 76.4% (95% CI 70.5% - 81.4%) | |
| Specificity | 97.4% (95% CI 95.3% - 98.6%) | 95.4% (95% CI 92.9% - 97.1%) | |
| Dermatitis herpetiformis | IgA | IgG | |
| Sensitivity | 35.6% (95% CI 22.3% - 51.3%) | 57.8% (95% CI 42.2% - 72.0%) | |
| Specificity | 97.4% (95% CI 95.3% - 98.6%) | 95.4% (95% CI 92.9% - 97.1%) |
Borderline / indeterminate results are considered negative:
| Celiac Disease | IgA | IgG |
|---|---|---|
| Sensitivity | 55.6% (95% CI 49.2% - 61.8%) | 68.4% (95% CI 62.2% - 74.0%) |
| Specificity | 98.5% (95% CI 96.7% - 99.3%) | 96.7% (95% CI 94.5% - 98.1%) |
| Dermatitis herpetiformis | IgA | IgG |
| Sensitivity | 33.3% (95% CI 20.4% - 49.1%) | 55.6% (95% CI 40.1% - 70.0%) |
98.5% (95% CI 96.7% - 99.3%)
Kuin Ceur
Kevin J. Lawson VP Regulatory Affairs
Specificity