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Bindazyme Anti-Tissue Transglutaminase Iga Eia

by The Binding Site, Ltd. 510(k)

Active United States

510(k) K993612

Overview

The Bindzyme Anti-Tissue Transglutaminase IgA EIA is an in-vitro diagnostic enzyme immunoassay that measures specific IgA autoantibodies against tissue transglutaminase (tTG) in patient serum samples. This assay provides quantitative or qualitative results to assist clinicians in the diagnosis of Coeliac disease.

The device is used in clinical laboratory settings by trained laboratory personnel. It is classified as an Autoantibodies, Endomysial (Tissue Transglutaminase) device with product code MVM, Class II - Special Controls. The device received FDA 510(k) clearance with number K993612 on December 21, 1999.

AI-generated from registry data, 22 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK993612 Date21 Dec 1999ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
MVM
Device Class
Class II
Regulation
21 CFR Part 866.5660
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the purpose of the Bindzyme Anti-Tissue Transglutaminase IgA EIA?

    This in-vitro diagnostic enzyme immunoassay measures specific IgA autoantibodies against tissue transglutaminase in patient serum samples to assist clinicians in the diagnosis of Coeliac disease.

  • How is the Bindzyme Anti-Tissue Transglutaminase IgA EIA supplied?

    The device is supplied as an in-vitro diagnostic enzyme immunoassay kit for use in clinical laboratory settings by trained laboratory personnel. The specific components and packaging details are not specified in the provided information.

  • What is the regulatory status of the Bindzyme Anti-Tissue Transglutaminase IgA EIA?

    The device received FDA 510(k) clearance with number K993612 on December 21, 1999. It is classified as an Autoantibodies, Endomysial (Tissue Transglutaminase) device with product code MVM, Class II - Special Controls.

  • How are the results from the Bindzyme Anti-Tissue Transglutaminase IgA EIA interpreted?

    The assay provides quantitative or qualitative results to assist clinicians in diagnosing Coeliac disease. The specific interpretation guidelines and reference ranges would be included in the product's instructions for use.