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510(k) Data Aggregation

    K Number
    K080485
    Device Name
    ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS
    Manufacturer
    DIASYS DIAGNOSTICS SYSTEMS GMBH
    Date Cleared
    2008-12-04

    (286 days)

    Product Code
    CIT, JIT, JJX
    Regulation Number
    862.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIASYS DIAGNOSTICS SYSTEMS GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ASAT (GOT) FS assay is intended for quantitative in vitro diagnostic determination of the activity of the enzyme aspartate amino transferase (AST) in human serum and lithium heparin plasma on the Hitachi 917 instrument. Measurement of aspartate amino transferase levels aids in the diagnosis and treatment of certain types of liver and heart disease. For in vitro diagnostic use on the Hitachi 917 instrument. TruCal U is used as a calibrator for the DiaSys ASAT (GOT) FS assay. For in vitro diagnostic use for quantitative testing on the Hitachi 917 instrument. TruLab N and TruLab P control sera are used to monitor accuracy and precision for the DiaSys ASAT (GOT) FS assay.
    Device Description
    The DiaSys ASAT (GOT) FS assay is based on NADH reduction to NAD, as shown in the following equation: L-Aspartate + 2-Oxoglutarate <ASAT> L-Glutamate + Oxalacetate Oxalacetate + NADH + H' < MDH > L-Malate + NAD* Addition of pyridoxal-5-phosphate (P-5-P) stabilizes the transaminases and avoids falsely low values in samples containing insufficient endogenous P-5-P, e.g. from patients with myocardial infarction, liver disease and intensive care patients . TraCal U calibrator-Serum based calibrator for use in the calibration of the quantitative DiaSys ASAT (GOT) FS assay on Hitachi 917. Trulab N and TruLab P controls-Serum based control serum in normal and pathological range for use in quality control for monitoring accuracy and precision of the quantitative DiaSys ASAT (GOT) FS assay on Hitachi 917.
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