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510(k) Data Aggregation

    K Number
    K991136
    Device Name
    B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM
    Manufacturer
    OLYMPUS AMERICA, INC.
    Date Cleared
    1999-05-11

    (36 days)

    Product Code
    JZG
    Regulation Number
    866.5630
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM

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

    The Olympus Beta-2-Microglobulin reagent is intended for use on Olympus Clinical Chemistry Analzyers for the quantitative determination of Beta-2-Microglobulin in human serum. Measurements of the amount of Beta-2-Microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter for the Olympus Beta-2-Microglobulin reagent. It does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, or study methodologies that would typically be found in a detailed device study report.

    Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study proving the device meets them based only on the provided text. The document is essentially an FDA approval letter, confirming that the device is substantially equivalent to a legally marketed predicate device, but it doesn't detail the performance studies themselves.

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