BEUDAMED
    Product Code: OAU FDA class 2 21 CFR 866.6030

    Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

    Immunology

    The Des-Gamma-Carboxy-Prothrombin (DCP), Risk Assessment, Hepatocellular Carcinoma device (product code OAU) is a quantitative in vitro diagnostic immunoassay that measures DCP (also known as PIVKA-II) in human serum to aid in the risk assessment of patients with chronic liver disease for progression to hepatocellular carcinoma (HCC), used in conjunction with imaging studies and clinical assessment. It is classified as FDA Class 2, requiring 510(k) clearance, and is regulated under 21 CFR 866.6030 within the Immunology specialty. Third-party 510(k) review is available for this device type.

    View on FDA
    510(k)s
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    OAU
    Device Class
    FDA class 2
    Regulation Number
    866.6030
    Medical Specialty
    Immunology
    Review Panel
    IM
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    The test is intended to quantitatively measure dcp in human serum and use as an aid in the risk assessment of patients with chronic liver disease for progression to hepatocellular carcinoma (hcc) in conjunction with other laboratory findings, imaging studies and clinical assessment for risk assessment of patients with chronic liver disease for progression to hepatocellular carcinoma.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K062368 WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401

    FEI Numbers

    This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.