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510(k) Data Aggregation

    K Number
    K971485
    Device Name
    URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
    Manufacturer
    TRACE AMERICA, INC.
    Date Cleared
    1997-05-27

    (34 days)

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

    URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)

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

    Intended for the In Vitro, quantitative determination of Uric Acid in human serum and urine for clinical diagnosis.

    "This Uric Acid test system is a device intended to measure uric acid in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs", CFR 862.1775

    Device Description

    TRACE !!!ric Acid - DST Reagent

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA to TRACE America, Inc. for their Uric Acid - DST Reagent. It states that the device is substantially equivalent to legally marketed predicate devices. However, this letter does not contain any information about acceptance criteria, study details, or performance data as requested in your prompt.

    Therefore, I cannot extract the requested information from this document. To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness, a clinical trial report, or the 510(k) submission itself, which would typically include such details.

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