LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K990204
    Device Name
    GLIADIN IGG ELISA TEST SYSTEM
    Manufacturer
    ZEUS SCIENTIFIC, INC.
    Date Cleared
    1999-03-26

    (64 days)

    Product Code
    MST
    Regulation Number
    866.5750
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Zeus Scientific, Inc. Gliadin IgG ELISA test system is intended for the qualitative and quantitative determination of IgG-class antibodies to gliadin in human serum. The test system is intended to be used as an aid in the diagnosis of gastrointestinal disorders, mainly Coeliac Disease. This test is for in vitro diagnostic use.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the "Gliadin IgG ELISA Test System." It confirms the device's substantial equivalence to legally marketed devices but does not include any study data, acceptance criteria, or performance metrics.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on the device being substantially equivalent, rather than detailing the specifics of a clinical study or performance validation.

    To answer your request, information regarding acceptance criteria and performance data would need to be found in the actual 510(k) submission document itself, which is not provided here.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1