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510(k) Data Aggregation

    K Number
    K062368
    Device Name
    WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401
    Manufacturer
    WAKO CHEMICALS, USA, INC.
    Date Cleared
    2007-01-31

    (170 days)

    Product Code
    OAU, JIT, JJX
    Regulation Number
    866.6030
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    Product Code :

    OAU

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wako LBA DCP immunological test system is an in vitro device that consists of reagents and an automated instrument used to quantitatively measure by immunochemical techniques DCP in human serum. The device is intended for in vitro diagnostic use as an aid in the risk assessment of patients with chronic liver disease for progression to hepatocellular carcinoma in conjunction with other laboratory findings, imaging studies and clinical assessment.
    Device Description
    The Wako LBA DCP immunological test system is an in vitro device that consists of reagents and an automated instrument used to quantitatively measure by immunochemical techniques DCP in human serum. The Wako LBA DCP assay is test kit for the quantitative determination of DCP based on a new method, LBA (Liquid-phase Binding Assay). The method uses a liquid-phase binding reaction between antigen and antibody and separates bound and free forms by column chromatography without a need for a solid phase. LBA DCP can offer fully automatic and highly precise DCP measurement by using an automated analyzer "LiBASys". This reagent consists of anti-DCP monoclonal antibodies and anti-Prothrombin monoclonal antibodies which are used as Fab' molecules and a substrate for fluorophotometric measurement.
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