BEUDAMED
    FDA PMA FDA Class 2 Approved (Reclassification) 🇺🇸 United States

    Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

    PMA: P100017 · Decision May 17, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10

    Basic Information

    Device Name
    Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
    Trade Name
    ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV
    PMA Number
    P100017
    Device Class
    FDA Class 2
    Product Code
    MZP
    Generic Name
    Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
    Regulation Number
    866.3170
    Medical Specialty
    Microbiology
    Advisory Committee
    Microbiology
    Decision
    Approved (Reclassification)
    Decision Code
    APRL
    Decision Date
    May 17, 2011
    Date Received
    May 18, 2010
    Expedited Review
    N
    Docket Number
    11M-0349

    Advisory Committee Statement

    THE APPROVAL OF REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HCV CONTROL KIT, ABBOTT REALTIME HCV CALIBRATOR KIT, AND OPTIONAL UNG URACIL-N-GLYCOSYLASE (UNG) FOR USE IN CONJUNCTION WITH ABBOTT REALTIME HCV. THIS DEVICE IS INDICATED FOR: ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, THE ABBOTT REAL TIME HCV ASSAY IS AN IN VITRO REVERSE TRANSCRIPTION- POLYMERASE CHAIN REACTION (RT-PCR) ASSAY FOR USE WITH THE ABBOTT MSAMPLE PREPARATION SYSTEM REAGENTS AND WITH THE ABBOTT M2000SP AND M2000RY4 INSTRUMENTS FOR THE QUANTITATION OF HEPATITIS C VIRAL (HCV) RNA IN HUMAN SERUM OR PLASMA (EDTA) FROM HCV-INFECTED INDIVIDUALS. SPECIMENS CONTAINING HCV GENOTYPES 1-6 HAVE BEEN VALIDATED FOR QUANTITATION IN THE ASSAY. THE ABBOTT REALTIME HCV ASSAY IS INTENDED FOR USE AS AN AID IN THE MANAGEMENT OF HCV-INFECTED PATIENTS UNDERGOING ANTIVIRAL THERAPY. THE ASSAY MEASURES HCV RNA LEVELS AT BASELINE AND DURING TREATMENT AND CAN BE UTILIZED TO PREDICT SUSTAINED AND NON- SUSTAINED VIROLOGICAL RESPONSE TO HCV THERAPY. THE RESULTS FROM THE REALTIME HCV ASSAY MUST BE INTERPRETED WITHIN THE CONTEXT OF ALL RELEVANT CLINICAL AND LABORATORY FINDINGS. ASSAY PERFORMANCE CHARACTERISTICS HAVE BEEN ESTABLISHED FOR INDIVIDUALS TREATED WITH PEGINTERFERON ALFA-2A OR 2B PLUS RIBAVIRIN. NO INFORMATION IS AVAILABLE ON THE ASSAYS PREDICTIVE VALUE WHEN OTHER THERAPIES ARE USED. ASSAY PERFORMANCE FOR DETERMINING THE STATE OF HCV INFECTION HAS NOT BEEN ESTABLISHED. THE ABBOTT REALTIME HCV ASSAY IS NOT FOR SCREENING BLOOD, PLASMA, SERUM OR TISSUE DONORS FOR HCV, OR TO BE USED AS A DIAGNOSTIC TEST TO CONFIRM THE PRESENCE OF HCV INFECTION. ABBOTT REALTIME HCV CONTROL KIT, THE ABBOTT REALTIME HCV CONTROLS ARE USED TO ESTABLISH RUN VALIDITY OF THE ABBOTT REALTIME HCV ASSAY WHEN USED FOR THE QUANTITATION OF HEPATITIS C VIRUS (HCV) RNA IN HUMAN SERUM AND PLASMA (EDTA) FROM HCV INFECTED INDIVIDUALS...FOR ADDITIONAL INFO REFER TO APPROVAL ORDER.

    Classifications

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

    Product Code Device Name
    MZP Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus