BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Hepatitis Viral B Dna Detection

    PMA: P050028 · Supplement: S004 · Decision Sep 9, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Hepatitis Viral B Dna Detection
    Trade Name
    COBAS AMPLIPREP/COBAS TAQMAN HBV TEST
    PMA Number
    P050028
    Supplement Number
    S004
    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
    September 9, 2010
    Date Received
    July 1, 2009
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A DEVICE DESIGN MODIFICATION THAT INCLUDES REAGENTS, DISPOSABLES,AND INSTRUMENTATION, TO AUTOMATE THE MANUAL SAMPLE PREPARATION PROCESS CURRENTLY USED BY THE COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM. THE DEVICE, AS MODIFIED,WILL BE MARKETED UNDER THE TRADE NAME COBAS AMPLIPREP/ COBAS TAQMAN HBV TEST, V2.0AND IS INDICATED FOR:THE COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0 IS AN IN VITRO NUCLEIC ACIDAMPLIFICATION LEST FOR THE QUANTITATION OF HEPATITIS B VIRUS (HBV) DNA IN HUMAN SERUM ORPLASMA (EDTA), USING THE COBAS AMPLIPREP INSTRUMENT FOR AUTOMATED SPECIMEN PROCESSINGAND THE COBAS TAQMAN ANALYZER OR COBAS TAQMAN 48 ANALYZER FOR AUTOMATEDAMPLIFICATION AND DETECTION.THIS TEST IS INTENDED FOR USE AS AN AID IN THE MANAGEMENT OF PATIENTS WITH CHRONIC HBV INFECTIONUNDERGOING ANTIVIRAL THERAPY. THE TEST CAN BE USED TO MEASURE HBV DNA LEVELS AT BASELINE AND DURING TREATMENT TO AID IN ASSESSING RESPONSE TO TREATMENT. THE RESULTS FROM THE COBASAMPLIPREP/ COBAS TAQMAN1 HBV TEST, V2.0 MUST BE INTERPRETED WITHIN THE CONTEXT OF ALLRELEVANT CLINICAL AND LABORATORY FINDINGS.ASSAY PERFORMANCE CHARACTERISTICS HAVE BEEN ESTABLISHED FOR INDIVIDUALS TREATED WITH ADEFOVIRDIPIVOXIL. ASSAY PERFORMANCE FOR DETERMINING THE SLATE OF HBV INFECTION HAS NOT BEEN ESTABLISHED.THE COBAS AMPLIPREP/ COBAS TAQMAN HBV TEST, V2.0 IS NOT INTENDED FOR USE AS A SCREENING TEST FOR THE PRESENCE OF HBV IN BLOOD OR BLOOD PRODUCTS OR AS A DIAGNOSTIC TEST TOCONFIRM THE PRESENCE OF HBV INFECTION.

    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