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510(k) Data Aggregation

    K Number
    K060157
    Device Name
    IMMUGLO ANTI-ENDOMYSIAL ANTIBODY IFA
    Manufacturer
    IMMCO DIAGNOSTICS, INC.
    Date Cleared
    2006-05-25

    (125 days)

    Product Code
    MVM
    Regulation Number
    866.5660
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    An indirect immunofluorescence assay (IFA) for the detection of and semi-quantitation of endomysial antibodies (EMA) in human serum to aid in the diagnosis of Celiac Disease (CD) and Dermatitis Herpetiformis (DH) in combination with other clinical and other laboratory findings.

    Device Description

    An indirect immunofluorescence assay (IFA) for the detection of and semi-quantitation of endomysial antibodies (EMA) in human serum.

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a diagnostic device. It does not contain the detailed study information required to answer your questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert qualifications.

    The letter acknowledges the device's substantial equivalence to a predicate device and states its intended use, but it does not include the results of performance studies that would typically be found in the 510(k) summary or the full submission.

    Therefore, I cannot provide the requested information from the given text.

    If you have access to the actual 510(k) submission (K060157), specifically the "Device Description," "Performance Characteristics," or "Summary of Nonclinical and/or Clinical Studies" sections, that is where you would find the details needed to answer your questions.

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