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510(k) Data Aggregation

    K Number
    K964341
    Device Name
    IGA ANTI-GLIADIN (IGA-AGA) ANTIBODY TEST KIT
    Manufacturer
    IMMCO DIAGNOSTICS, INC.
    Date Cleared
    1997-05-30

    (211 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

    An enzyme linked immunosorbent assay (ELISA) for the detection and semiquantitation of IgA anti-gliadin antibodies in human serum to aid in the diagnosis of patients with celiac disease and dermatitis herpetiformis.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information needed to construct the table of acceptance criteria and the study that proves the device meets those criteria.

    The document is a 510(k) clearance letter from the FDA for the "IgA Anti-Gliadin (IgA-AGA) Antibody Test Kit". It acknowledges significant equivalence to a predicate device and states the indications for use. However, it does not provide:

    • Specific acceptance criteria (e.g., sensitivity, specificity thresholds).
    • Reported device performance values against these criteria.
    • Details about the study design, sample sizes, data provenance, expert qualifications, adjudication methods, or ground truth establishment for either training or test sets.

    Therefore, I cannot fulfill your request based on the provided input.

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