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510(k) Data Aggregation

    K Number
    K970452
    Device Name
    ELECSYS CALCHECK CEA
    Manufacturer
    BOEHRINGER MANNHEIM CORP.
    Date Cleared
    1997-03-06

    (28 days)

    Product Code
    JJX
    Regulation Number
    862.1660
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    K963147
    Predicate For
    K101856
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Elecsys® CalCheck™ CEA is used to verify the calibration assignment for the Elecsys® CEA assay.

    Device Description

    The Elecsys® CalCheck™ CEA is a three level single analyte set of lyophilized, human based materials. After reconstitution, they are assayed in triplicate and the results compared to the target values.

    AI/ML Overview

    This is a pre-AI/ML device, and the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria in the context of AI/ML performance. The device is a calibration verification material for an immunoassay. Therefore, I cannot fulfill your request based on the provided input.

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