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510(k) Data Aggregation

    K Number
    K974620
    Device Name
    AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)
    Manufacturer
    TRACE AMERICA, INC.
    Date Cleared
    1998-01-02

    (22 days)

    Product Code
    JIF
    Regulation Number
    862.1065
    Type
    Traditional
    Panel
    Clinical Chemistry (CH)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)

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

    Intended for the the In Vitro, quantitative determination of Ammonia (NH,) in human plasma on automated systems.

    Ammonia measurements are used in the diagnosis and treatment of severe liver disorders such as circhosis, hepatitus, and Reye's syndrome. " CFR 862.1065

    Device Description

    Ammonia-Incorporating Dynamic Stabilization Technology (DST)

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the device "Ammonia-Incorporating Dynamic Stabilization Technology (DST)". It outlines that the device is intended for "the In Vitro, quantitative determination of Ammonia (NH,) in human plasma on automated systems." and that "Ammonia measurements are used in the diagnosis and treatment of severe liver disorders such as circhosis, hepatitus, and Reye's syndrome."

    However, this document does not contain any information regarding acceptance criteria, study details, performance data, sample sizes, or ground truth establishment. It is a regulatory clearance document, not a clinical study report. Therefore, I cannot generate the requested information based on the provided text.

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