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510(k) Data Aggregation

    K Number
    K993087
    Device Name
    AUTOSTAT II ANTI-GLIADIN IGG ELISA
    Manufacturer
    COGENT DIAGNOTICS LTD.
    Date Cleared
    1999-11-12

    (58 days)

    Product Code
    MST
    Regulation Number
    866.5750
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AUTOSTAT II ANTI-GLIADIN IGG ELISA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to gliadin in human serum.

    Uses:

    The results of the anti-gliadin IgG assay can be used as an aid in the diagnosis of diseases associated with elevated levels of anti-gliadin antibodies including Coeliac Disease.

    Levels of these antibodies are one indicator in a multi-factorial diagnostic regime.

    The assay may be used on the Hycor Hy•Tec Automated EIA instrument.

    For in vitro diagnostic use only.

    Device Description

    Not Found

    AI/ML Overview

    This FDA communication is a clearance letter for a medical device (Autostat™ II Anti-Gliadin IgG ELISA). It indicates that the device has been reviewed and found to be "substantially equivalent" to legally marketed predicate devices. However, the document does not contain the acceptance criteria for the device's performance, nor does it detail the study that proves the device meets those criteria.

    Therefore, I cannot extract the requested information from this document. The letter focuses on regulatory approval based on equivalence rather than presenting performance data or study specifics.

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