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510(k) Data Aggregation

    K Number
    K981373
    Device Name
    ALKPHASE-B ASSAY KIT
    Manufacturer
    METRA BIOSYSTEMS, INC.
    Date Cleared
    1998-05-27

    (41 days)

    Product Code
    CIN
    Regulation Number
    862.1050
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ALKPHASE-B ASSAY KIT

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

    Measurement of BAP is intended for use as an aid in the:

    management of postmenopausal osteoporosis and Paget's disease.

    monitoring of postmenopausal women on hormonal or bisphosphonate therapy

    prediction of skeletal response to hormonal therapy in postmenopausal women.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text from the FDA 510(k) letter for the Alkphase-B® Assay Kit does not contain information about the acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment. The document is an FDA letter granting substantial equivalence, not a detailed study report. Therefore, I cannot generate the requested table and paragraphs based on this input.

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