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510(k) Data Aggregation

    K Number
    K971908
    Device Name
    CREA OR CREATININE
    Manufacturer
    CAROLINA LIQUID CHEMISTRIES CORP.
    Date Cleared
    1997-06-17

    (25 days)

    Product Code
    CGX
    Regulation Number
    862.1225
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CREA OR CREATININE

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

    Creatinine Reagent is intended for the quantitative determination of serum creatinine using the Beckman SYNCHRON CX Clinical Systems. The results are used in the diagnosis and treatment of renal malfunction.

    Device Description

    Creatinine Reagent

    AI/ML Overview

    I am sorry, but the provided text from the FDA 510(k) summary does not contain the detailed information necessary to complete all sections of your request regarding acceptance criteria and a study proving the device meets them.

    The document is a letter from the FDA stating that the "Creatinine Reagent" device is substantially equivalent to legally marketed predicate devices, and it allows the manufacturer to begin marketing the device. It also includes the "Indications For Use." However, it does not contain any information about specific acceptance criteria (performance metrics), the details of any study that was conducted (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies), or standalone algorithm performance.

    Therefore, I cannot generate the table or the other requested points based solely on the provided text. The 510(k) summary typically points to a separate document (which is not provided here) that would contain such study details.

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