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    K Number
    K970146
    Device Name
    ELECSYS CALCHECK TESTOSTERONE
    Manufacturer
    BOEHRINGER MANNHEIM CORP.
    Date Cleared
    1997-01-30

    (15 days)

    Product Code
    JJX
    Regulation Number
    862.1660
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K924863
    Why did this record match?
    Device Name :

    ELECSYS CALCHECK TESTOSTERONE

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

    The Boehringer Mannheim Elecsys CalCheck Testosterone is used to verify the calibration assignment for the Boehringer Mannheim Elecsys Testosterone assay.

    Device Description

    The Boehringer Mannheim Elecsys CalCheck Testosterone is manufactured using human serum albumin, testosterone, stabilizers, and preservatives. The analyte is appropriately spiked into the calcheck matrix to the correct calcheck concentration levels. The calchecks are in process checked and quality controlled against ID-GC/MS.

    AI/ML Overview

    This is a calibration verification product, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study design for AI/ML performance, sample sizes, expert involvement, and ground truth establishment, MRMC studies, standalone performance, and training set details are not applicable as these concepts are specific to AI/ML device evaluations.

    The provided text describes a "Calibration Verification Material" (Elecsys CalCheck Testosterone) used to verify the calibration assignment for an assay. Its performance is evaluated based on "value assignment and stability."

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