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510(k) Data Aggregation

    K Number
    K023744
    Device Name
    WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354
    Manufacturer
    WIENER LABORATORIES S.A.I.C.
    Date Cleared
    2003-01-03

    (57 days)

    Product Code
    JHW
    Regulation Number
    862.1215
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354

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

    The "Wiener lab. CK-MB DS UV unitest" test system is a quantitative in vitro diagnostic device intended to measure the activity of the MB isoenzyme of creatine phosphokinase in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed study information, acceptance criteria, or device performance metrics needed to answer your request. The document is a 510(k) clearance letter from the FDA for a device called "Weiner lab. CK-MB DS UV unitest," which is a creatine phosphokinase/creatine kinase or isoenzymes test system.

    While it mentions the device's intended use and substantial equivalence to a predicate device, it does not include:

    • A table of acceptance criteria and reported device performance.
    • Details about specific studies, such as sample sizes, data provenance, ground truth establishment, or expert qualifications.
    • Information regarding MRMC comparative effectiveness studies or standalone algorithm performance.

    The letter is primarily a regulatory communication indicating that the device has met the requirements for market clearance, not a technical report detailing performance study results.

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