EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)

K183313 · Euroimmun Us, Inc. · MVM · Feb 28, 2019 · Immunology

Device Facts

• Record ID: K183313
• Device Name: EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)
• Applicant: Euroimmun Us, Inc.
• Product Code: MVM · Immunology
• Decision Date: Feb 28, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

The Anti-tissue Transglutaminase ELISA (IgA) test kit is intended for the qualitative or semi-quantitative determination of IgA class antibodies against tissue transglutaminase in human serum and EDTA plasma (K3-EDTA, Li+-heparin, Na+-citrate). It is used as an aid in the diagnosis of gluten-sensitive enteropathy (celiac disease) and dermatitis herpetiformis Duhring, in conjunction with other laboratory and clinical findings. The Anti-tissue Transglutaminase ELISA (IgG) test kit is intended for the qualitative determination of IgG class antibodies against tissue transglutaminase in human serum and EDTA plasma (K3-EDTA, Li+-heparin, Na+-citrate). It is used as an aid in the diagnosis of gluten-sensitive enteropathy (celiac disease), in conjunction with other laboratory and clinical findings.

Device Story

The Anti-tissue Transglutaminase ELISA (IgA/IgG) kits are in vitro diagnostic assays used to detect autoantibodies in human serum or plasma samples. The device utilizes enzyme-linked immunosorbent assay (ELISA) technology to identify specific IgA or IgG class antibodies against tissue transglutaminase. The test is performed in a clinical laboratory setting by trained personnel. The output is a qualitative determination of antibody presence, which clinicians use in conjunction with other laboratory and clinical findings to support a diagnosis of gluten-sensitive enteropathy (celiac disease) or dermatitis herpetiformis Duhring. By identifying these specific autoantibodies, the device assists healthcare providers in confirming the presence of autoimmune conditions related to gluten sensitivity, facilitating timely clinical management and patient care.

Clinical Evidence

Clinical validation included 102 biopsy-confirmed celiac disease patients and 166 autoimmune disease controls. Anti-tTG IgA sensitivity: 99.0% (celiac), 77.8% (dermatitis herpetiformis); specificity: 97.6%. Anti-tTG IgG sensitivity: 37.3% (celiac), 82.4% (IgA-deficient celiac); specificity: 99.4%. Method comparison against predicates showed positive percent agreement of 90.9% (IgA) and 89.2% (IgG). Analytical performance included precision (total CVs 5.6-17.1%), linearity (2-200 RU/mL for IgA), and LoD (1.1 RU/mL for IgA).

Technological Characteristics

ELISA-based immunological test system for qualitative detection of autoantibodies. Analyte: tissue transglutaminase. Sample types: human serum and plasma (EDTA, heparin, citrate).

Indications for Use

Indicated for qualitative detection of IgA or IgG class antibodies against tissue transglutaminase in human serum and plasma to aid in the diagnosis of celiac disease and dermatitis herpetiformis Duhring. For prescription use only.

Regulatory Classification

Identification

A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).

Submission Summary (Full Text)

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February 28, 2019

EUROIMMUN US, Inc. Daniel Castellanos Senior Regulatory Affairs and Quality Management 1 Bloomfield Avenue Mountain Lakes, New Jersey 07046

Re: K183313

Trade/Device Name: Anti-tissue Transglutaminase ELISA (IgA), Anti-tissue Transglutaminase ELISA (IgG) Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: MVM Dated: November 28, 2018 Received: November 29, 2018

Dear Daniel Castellanos:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Douglas A. Jeffery -S

Doug Jeffery Branch Chief Immunology and Flow Cytometry Branch Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K183313

#### Device Name

Anti-tissue Transglutaminase ELISA (IgA) Anti-tissue Transglutaminase ELISA (IgG)

### Indications for Use (Describe)

The Anti-tissue Transglutaminase ELISA (IgA) test kit is intended for the qualitative determination of IgA class antibodies against tissue transglutaminase in human serum and EDTA plasma (K3-EDTA, Lit-heparin, Na+citrate). It is used as an aid in the diagnosis of gluten-sensitive enteropathy (celiac disease) and dermatitis herpetiformis Duhring, in conjunction with other laboratory and clinical findings.

The Anti-tissue Transglutaminase ELISA (IgG) test kit is intended for the qualitative determination of IgC class antibodies against tissue transglutaminase in human serum and EDTA plasma (K3-EDTA, Li+-citrate). It is used as an aid in the diagnosis of gluten-sensitive enteropathy (celiac disease), in conjunction with other laboratory and clinical findings.

| Type of Use (Select one or both, as applicable) |
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| <div> <input checked="true" type="checkbox"/> Transactional (For 26 CFR 301.6109-1(d)) </div> | <div> <input type="checkbox"/> Grantor Reporting Method (For 26 CFR 1.671-4(a)) </div> |
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|X | Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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