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K Number
K982366
Device Name
QUANTA LITE TTG (TISSUE TRANSGLUTAMINASE) ELISA
Manufacturer
INOVA DIAGNOSTICS, INC.
Date Cleared
1998-08-27

(51 days)

Product Code
MVM
Regulation Number
866.5660
Type
Traditional
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 semi-quantitative detection of IgA antibodies to 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

An Enzyme Linked Immunosorbant Assay (ELISA)

AI/ML Overview

The provided text is a 510(k) premarket notification approval letter for an in vitro diagnostic device, the QUANTA Lite™ Tissue Transglutaminase ELISA. It does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and the study proving the device meets those criteria.

Specifically, the document does not include:

  • A table of acceptance criteria and reported device performance.
  • Sample sizes used for the test set or data provenance.
  • Number of experts used to establish ground truth or their qualifications.
  • Adjudication method.
  • Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
  • Information about standalone (algorithm only) performance.
  • The type of ground truth used for the test set or training set.
  • Sample size for the training set.
  • How ground truth for the training set was established.

The document does mention:

  • Device Name: QUANTA Lite™ Tissue Transglutaminase ELISA.
  • Indications For Use: "An Enzyme Linked Immunosorbant Assay (ELISA) for the semi-quantitative detection of IgA antibodies to 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."
  • Regulatory Class: II

To answer your request comprehensively, a more detailed study report or dossier for the device would be required, typically found in the 510(k) submission itself rather than the approval letter.

Without that specific study information, I can only provide what would typically be expected in such a study for an ELISA diagnostic device, but I cannot extract it directly from the provided text.

§ 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).