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510(k) Data Aggregation

    K Number
    K991834
    Device Name
    CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772
    Manufacturer
    CHOLESTECH CORP.
    Date Cleared
    1999-09-09

    (104 days)

    Product Code
    CKD
    Regulation Number
    862.1030
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    Product Code :

    CKD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cholestech L·D·X Alanine aminotransferase Test (ALT) is for the in vitro quantitative determination of alanine aminotransferase (ALT) in whole blood or serum on the Cholestech L.D.X Analyzer. Alanine aminotransferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.
    Device Description
    The Cholestech L·D·X Alanine Aminotransferase Test (ALT) combines an enzymatic methodology and a solid-phase technology to measure ALT in whole blood or serum. Blood from a fingerstick is collected into a lithium heparin coated capillary tube (venous whole blood serum is also acceptable) and dispensed into a L·D·X cassette. The cassette is then placed into the Cholestech L·D·X where a unique system separates the plasma from the blood cells. The plasma flows to both sides of the cassette and is transferred to the ALT reaction pad. The Cholestech L•D•X Analyzer measures alanine aminotransferase by an enzymatic method based on the method formulation of Katsuyama et al. Alanine aminotransferase catalyzes the transfer of amino groups from L-Alanine and α-Ketoglutarate to pyruvate and glutamate. Pyruvate oxidase, in the presence of oxygen, oxidizes the pyruvate to acetylphosphate and hydrogen peroxide. In a reaction catalyzed by horseradish peroxidase, the peroxide reacts with an indicator dye to form a blue color at a rate proportional to the ALT concentration of the sample. The resultant color in the reaction is measured by reflectance photometry. L-Alanine + α -Ketoglutarate Alanine Aminotransferase → Pyruvate + Glutamate Pyruvate + Phosphate + O2 + H2O Pyruvate Oxidase → Acetylphosphate + CO2 + H2O2 Indicator + H2O2 Peroxidase → Colored Blue Dye + H2O A brown magnetic stripe on each cassette contains the calibration information required for the Cholestech L•D•X Analyzer to convert the reflectance reading to the ALT concentration in U/L at 37° C.
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