BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Hepatitis Viral B Dna Detection

    PMA: P080026 · Decision Aug 13, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Hepatitis Viral B Dna Detection
    Trade Name
    ABBOTT REALTIME HBV ASSAY
    PMA Number
    P080026
    Device Class
    FDA Class 3
    Product Code
    MKT
    Generic Name
    Hepatitis Viral B DNA Detection
    Medical Specialty
    Unknown
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 13, 2010
    Date Received
    October 16, 2008
    Expedited Review
    N
    Docket Number
    10M-0519

    Advisory Committee Statement

    APPROVAL FOR THE ABBOTTREALTIME HBV. THE DEVICE IS INDICATED FOR:ABBOTT REALTIME HBV ASSAY:ABBOTT REALTIME HBV ASSAY IS AN IN VITRO POLYMERASE CHAIN REACTION (PCR) ASSAY FOR USE WITH THE ABBOTT M2000 SYSTEMDNA REAGENTS AND WITH THE ABBOTT M200SP AND M2OOORT INSTRUMENTSFOR THE QUANTITATION OF HEPATITIS B VIRUS (HBV) DNA IN HUMAN SERUM OR PLASMA (EDTA) FROM CHRONICALLY HBV-INFECTED INDIVIDUALS. THE ASSAY IS INTENDED FOR USE AS AN AID IN THEMANAGEMENT OF PATIENTS WITH CHRONIC HBV INFECTION UNDERGOING ANTI-VIRAL THERAPY. THE ASSAY CAN BE USED TO MEASURE HBV DNA LEVELS AT BASELINE AND DURING TREATMENT TO AID IN ASSESSING RESPONSE TO TREATMENT. THE RESULTS FROM THE ABBOTT REALTIME HBV ASSAY MUST BE INTERPRETED WITHIN THE CONTEXT OF ALL RELEVANT CLINICAL AND LABORATORY FINDINGS. ASSAY PERFORMANCE FOR DETERMINING THE CLINICAL STAGE OF HBV INFECTION HAS NOT BEEN ESTABLISHED. CLINICAL PERFORMANCECHARACTERISTICS HAVE BEEN ESTABLISHED FOR INDIVIDUALS TREATED WITH ADEFOVIR DIPIVOXIL. THIS ASSAYIS NOT INTENDED FOR USE AS A SCREENING TEST IN BLOOD OR BLOOD PRODUCTS FOR HBV OR AS A DIAGNOSTIC TEST TO CONFIRM THE PRESENCE OF HBV INFECTION. ABBOTT REALTIME HBV ASSAY CONTROL KIT:THE ABBOTT REALTIME HBV CONTROLS ARC USED TO ESTABLISH RUN VALIDITY OF THE ABBOTT REALTIMEHBV ASSAY WHEN USED FOR THE QUANTITATION OF HEPATITIS B VIRUS (HBV) DNA IN HUMAN SERUMAND PLASMA (EDTA) FROM HBV INFECTED INDIVIDUALS.ABBOTT REALTIME HBV ASSAY CALIBRATOR KIT:THE ABBOTT REALTIME HBV CALIBRATORS ARE FOR CALIBRATION OF THE ABBOTT REALTIME HBV ASSAY WHEN USED FOR THE QUANTITATION DETERMINATION OF HEPATITIS B VIRUS (HBV) DNA IN HUMAN SERUM AND PLASMA (EDTA) FROM HBV INFECTED INDIVIDUALS.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MKT Hepatitis Viral B Dna Detection