LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K971754
    Device Name
    LIQUID GLUCOSE (HEXOKINASE) REAGENT SET
    Manufacturer
    POINTE SCIENTIFIC, INC.
    Date Cleared
    1997-07-22

    (71 days)

    Product Code
    CFR
    Regulation Number
    862.1345
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of glucose in serum or plasma. It is intended for in vitro diagnostic use only. The determination of glucose in serum is most commonly performed for the diagnosis and treatment of diabetes mellitus.

    Device Description

    Liquid Glucose (Hexokinase) Reagent Set

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a Liquid Glucose (Hexokinase) Reagent Set, which primarily details the regulatory approval of the device based on substantial equivalence to a predicate device. It does not include details about specific performance studies, acceptance criteria, sample sizes, ground truth establishment, or expert qualifications.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1