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510(k) Data Aggregation

    K Number
    K980525
    Device Name
    UBAS MANUAL METHOD AND UBAS AUTOMATED METHOD
    Manufacturer
    MARUKIN SHOYU CO., LTD.
    Date Cleared
    1998-04-15

    (63 days)

    Product Code
    KWX
    Regulation Number
    862.1187
    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 Marukin Shoyu Co., Ltd's Assay Kits for Urinary Total Bile Acid Sulfate is intended for the colorimetric determination of urinary total bile acid sulfate (UBAS) in children and adults.

    Device Description

    Assay Kits for Urinary Total Bile Acid Sulfate

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for "Assay Kits for Urinary Total Bile Acid Sulfate". This type of document does not contain the information requested regarding acceptance criteria studies, sample sizes, expert qualifications, or details about AI/ML models.

    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 (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976...". This means the device was cleared based on its substantial equivalence to a legally marketed predicate device, not on a new clinical trial demonstrating meeting specific performance criteria in the way a novel AI/ML device would.

    Therefore, I cannot provide the requested information from this document.

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