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510(k) Data Aggregation

    K Number
    K082001
    Device Name
    DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B
    Manufacturer
    DIAZYME LABORATORIES
    Date Cleared
    2008-12-05

    (144 days)

    Product Code
    JII
    Regulation Number
    862.3560
    Why did this record match?
    Product Code :

    JII

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Diazyme Liquid Enzymatic Assay Kit is for quantitative in vitro determination of Lithium in human serum. Measurements of Lithium are carried out essentially to ensure that proper drug dosage is administered in the treatment of patient suffering from bipolar disorder and to avoid toxicity.
    Device Description
    Not Found
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    K Number
    K033360
    Device Name
    DIAZYME LITHIUM ENZYMATIC ASSAY KIT
    Manufacturer
    GENERAL ATOMICS
    Date Cleared
    2003-12-23

    (63 days)

    Product Code
    JII
    Regulation Number
    862.3560
    Why did this record match?
    Product Code :

    JII

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Diazyme Lithium Enzymatic Assay Kit is for quantitative in vitro determination of lithium in human serum and plasma. Measurements of lithium are carried out essentially to ensure that proper drug dosage is administered in the treatment of patient suffering from bipolar disorder and to avoid toxicity.
    Device Description
    Diazyme's lithium enzymatic assay is a spectrophotometric method, which can be adapted to most automated clinical chemistry analyzers. In Diazyme's lithium enzymatic assay, Lithium is determined spectrophotometrically through a kinetic coupling assay system involving a Diazyme's proprietary phosphatase whose activity is sensitive to lithium concentration (IC50=0.1mM). Through enzymatic coupling, the phosphatase substrate, adenosine biphosphate (PAP) is converted to hypoxanthine by a series of enzymatic reactions to generate uric acid and hydrogen peroxide (H2O2). H2O2 generated reacts with N-Ethyl-N-(2-hydroxy-3-sulfopropyl)-3-m-toluidine (EHSPT) and 4-aminoantipyrine (4-AA) in the presence of peroxidase (POD) to form a quinone dye which has maximal absorbance at 556nm. The rate of the quinine dye formation is inversely proportion to the concentration of lithium in serum samples.
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