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510(k) Data Aggregation

    K Number
    K043202

    Validate with FDA (Live)

    Device Name
    OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279
    Manufacturer
    OLYMPUS AMERICA, INC.
    Date Cleared
    2004-12-23

    (35 days)

    Product Code
    CGS
    Regulation Number
    862.1215
    Type
    Traditional
    Panel
    Clinical Chemistry
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    K191296
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Olympus Creatine Kinase reagent is intended for use in Olympus automated clinical The Organisation of creatify the quantitative determination of creatine kinase activity in human serum and plasma.

    Measurements of creatine kinase 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 from the FDA 510(k) approval letter for the "Olympus Creatine Kinase Reagent" does not contain the specific information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

    This document is a formal letter of clearance where the FDA determines that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. It outlines regulatory requirements and contact information but does not include the detailed technical study results or performance data that would typically be found in the 510(k) submission itself.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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