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510(k) Data Aggregation

    K Number
    K980026
    Device Name
    GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
    Manufacturer
    TRACE AMERICA, INC.
    Date Cleared
    1998-03-10

    (64 days)

    Product Code
    CFR
    Regulation Number
    862.1345
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)

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

    Intended for the In Vitro, quantitative determination of Glucose in human serum, plasma urine. This "Glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis andtreatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma". CFR862.1345

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a glucose test system. It does not contain specific acceptance criteria or details of a study demonstrating the device meets such criteria.

    The information provided is a regulatory approval, confirming that the device is substantially equivalent to a predicate device already on the market. It doesn't include performance metrics, study designs, or expert qualifications as requested in the prompt.

    Therefore, I cannot answer the specific questions about acceptance criteria and study details based on the provided text.

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