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K Number
K993612
Device Name
BINDAZYME ANTI-TISSUE TRANSGLUTAMINASE IGA EIA
Manufacturer
THE BINDING SITE, LTD.
Date Cleared
1999-12-21

(57 days)

Product Code
MVM
Regulation Number
866.5660
Type
Traditional
Panel
IM
Reference & Predicate Devices
N/A
Predicate For
K041002
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The in-vitro measurement of specific autoantibodies against tissue transglutaminase (tTG) present in serum as an aid in the diagnosis of Coeliac disease.

Device Description

BINDAZYME Anti-Tissue Transglutaminase IgA EIA Kit

AI/ML Overview

This document is a marketing authorization letter for a device called "BINDAZYME Anti-Tissue Transglutaminase IgA EIA". It does not contain information about acceptance criteria or a study proving device performance in the format requested. The document is a regulatory approval notice from the FDA, stating that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information from this document.

§ 866.5660 Multiple autoantibodies immunological test system.

(a)
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).(b)
Classification. Class II (performance standards).