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510(k) Data Aggregation

    K Number
    K974833
    Device Name
    CK-NAC REAGENT
    Manufacturer
    INTERSECT SYSTEMS, INC.
    Date Cleared
    1998-02-13

    (51 days)

    Product Code
    CGS
    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 Intersect CK Reagent is an in-vitro diagnostic product intended for use in the quantitative determination of creatine kinasc in human serum.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called "CK-NAC Reagent" (K974833). It states that the device is substantially equivalent to a predicate device for the quantitative determination of creatine kinase in human serum.

    Since this is an FDA clearance letter and not a detailed study report, it does not contain the specific information requested in your prompt regarding acceptance criteria, sample sizes, expert qualifications, or study methodologies. This type of document confirms regulatory approval based on demonstrating substantial equivalence, but it does not typically publish the full technical details of the underlying performance studies.

    Therefore, I cannot provide the requested information based on the provided text.

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