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510(k) Data Aggregation

    K Number
    K991247
    Device Name
    URIC ACID, MODEL UA112-01
    Manufacturer
    A.P. TOTAL CARE, INC.
    Date Cleared
    1999-05-25

    (43 days)

    Product Code
    KNK
    Regulation Number
    862.1775
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    URIC ACID, MODEL UA112-01

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

    The Uric Acid reagent, product No. UA112-01 is intended for Invitro Diagnostic use in the automated, quantitative determination of Uric Acis in serum, or plasma.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a Uric Acid reagent. It primarily focuses on the regulatory approval and substantial equivalence to a predicate device. It does not contain information typically found in a study report, such as:

    • Specific acceptance criteria and reported device performance: The letter states the device is "substantially equivalent" but provides no performance metrics or criteria.
    • Sample size and data provenance for a test set.
    • Number and qualifications of experts for ground truth establishment.
    • Adjudication method.
    • Result of a multi-reader multi-case (MRMC) comparative effectiveness study.
    • Standalone algorithm performance.
    • Type of ground truth used.
    • Training set sample size.
    • Method for establishing training set ground truth.

    Therefore, I cannot extract the requested information from the provided document as it does not contain the details of a performance study.

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