K Number
K011566
Date Cleared
2001-07-09

(49 days)

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

An Enzyme Linked Immunosorbant Assay (ELISA) for the semiquantitative detection of IgA antibodies to human tissue transglutaminase (endomysium) in human serum. Detection of these antibodies is an aid in diagnosis of certain gluten sensitive enteropathies such as celiac disease and dermatitis herpetiformis.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA to INOVA Diagnostics, Inc. regarding their INOVA QUANTA Lite h-tTG (Human Tissue Transglutaminase) IgA ELISA device. This document primarily focuses on FDA's determination of substantial equivalence for marketing purposes and does not contain the detailed study information, acceptance criteria, or performance data required to answer the prompt.

Therefore, I cannot extract the requested information from the provided text. The document is an approval letter, not a study report.

§ 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).