LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K011566
    Device Name
    QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    2001-07-09

    (49 days)

    Product Code
    MVM
    Regulation Number
    866.5660
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA

    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.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1