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510(k) Data Aggregation

    K Number
    K980012
    Device Name
    CREATINE KINASE REAGENT
    Manufacturer
    AC BIOCHEMICALS, INC.
    Date Cleared
    1998-02-25

    (54 days)

    Product Code
    JHX
    Regulation Number
    862.1215
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Creatine kinase Reagent is to be used in the assessment of cardiac and skeletal muscle diseases, including myocardial infarction and muscle dystrophy.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a Creatine Kinase Reagent. It states that the device has been found substantially equivalent to a predicate device for the assessment of cardiac and skeletal muscle diseases, including myocardial infarction and muscle dystrophy.

    However, the document does not contain any information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, or training set details. These are typical requirements for device validation studies, but this specific FDA letter is a regulatory clearance document, not a detailed study report.

    Therefore, I cannot provide the requested information from the given input.

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