LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    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
    Immunology
    Reference & Predicate Devices
    N/A
    Predicate For
    K053383
    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.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1