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510(k) Data Aggregation

    K Number
    K973900
    Device Name
    TESTOTERONE ELISA
    Manufacturer
    KMI DIAGNOSTICS, INC.
    Date Cleared
    1998-02-24

    (133 days)

    Product Code
    CDZ
    Regulation Number
    862.1680
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TESTOTERONE ELISA

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

    The IBL Testosterone assay is an Enzyme-Immunoassay (EIA) for the quantitative determination of Testosterone in human serum or plasma.

    Device Description

    Testosterone ELISA Test Kit

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a Testosterone ELISA Test Kit. It does not contain the detailed information required to answer the questions about acceptance criteria, study design, and performance metrics for a device that typically involves AI or image analysis.

    The letter explicitly states:
    "We have reviewed-your-Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976..."

    This is a substantial equivalence (SE) determination for a laboratory diagnostic test kit, not a performance study for a device evaluated against specific acceptance criteria in the way an AI-powered device would be. The clearance is based on the device being substantially equivalent to a predicate device already on the market, not on fulfilling novel performance criteria through a new study as would be required for a de novo or PMA submission.

    Therefore, the specific information requested in points 1-9 (acceptance criteria table, sample sizes for test/training, expert qualifications, ground truth methods, MRMC studies, standalone performance with AI, etc.) is not present in this document. This document confirms regulatory clearance based on substantial equivalence, which is a different type of review.

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