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510(k) Data Aggregation

    K Number
    K973897
    Device Name
    DHEA-S
    Manufacturer
    KMI DIAGNOSTICS, INC.
    Date Cleared
    1997-11-13

    (30 days)

    Product Code
    JKC
    Regulation Number
    862.1245
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The IBL DHEA-S ELISA test kit is intended for the in vitro determination of DHEA-S (dehydroepiandrosterone sulphate) in human serum and plasma. DHEA measurements are used in the diagnosis and treatment of DHEA-secreting adrenal carcinomas.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to KMI Diagnostics, Inc. regarding their IBL DHEA-S ELISA Test Kit. It confirms that the device is substantially equivalent to legally marketed predicate devices.

    However, the document does not contain any information about:

    • Acceptance criteria for device performance.
    • The study design or results that prove the device meets acceptance criteria.
    • Sample sizes for test or training sets.
    • Data provenance.
    • Number or qualifications of experts for ground truth.
    • Adjudication method.
    • MRMC comparative effectiveness study or effect size.
    • Standalone algorithm performance.
    • Type of ground truth used.
    • How ground truth was established for the training set.

    The document is purely a regulatory letter stating that the device is cleared for marketing based on substantial equivalence, not a summary of a performance study.

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