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

    Assay, Genotyping, Hepatitis C Virus

    PMA: P120012 · Decision Jun 20, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Assay, Genotyping, Hepatitis C Virus
    Trade Name
    ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)
    PMA Number
    P120012
    Device Class
    FDA Class 2
    Product Code
    OBF
    Generic Name
    Assay, genotyping, hepatitis c virus
    Regulation Number
    866.3170
    Medical Specialty
    Microbiology
    Advisory Committee
    Microbiology
    Decision
    Approved (Reclassification)
    Decision Code
    APRL
    Decision Date
    June 20, 2013
    Date Received
    July 12, 2012
    Expedited Review
    N
    Docket Number
    13M-0758

    Advisory Committee Statement

    APPROVAL FOR THE ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, AND URACIL-GLYCOSYLASE(UNG). THIS DEVICE IS INDICATED FOR: ABBOTT REALTIME HCV GENOTYPE IITHE ABBOTT REALTIME HCV GENOTYPE II 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 M2000RT INSTRUMENTS FOR THE QUALITATIVE IDENTIFICATION OFHEPATITIS C VIRUS (HCV) GENOTYPES 1, 1A, 1B, AND 2 - 5 IN PLASMA OR SERUM FROM INDIVIDUALS CHRONICALLY INFECTED WITH HCV.THE ABBOTT REALTIME HCV GENOTYPE II IS INTENDED FOR USE AS AN AID IN THE MANAGEMENT OF HCV-INFECTED INDIVIDUALS AND IN GUIDING THE SELECTION OF THERAPEUTIC TREATMENT INDICATED FOR THE ABOVE LISTED GENOTYPES. THE ASSAY IS INTENDED FOR USE ON PATIENTS WHO ARE CHRONICALLY INFECTED WITH HCV, ARE BEING CONSIDERED FOR ANTIVIRAL TREATMENT, AND ARE POSITIVE FOR HCV RNA. THE ABBOTT REALTIME HCV GENOTYPE II ASSAY IS NOT FOR SCREENING BLOOD, PLASMA, SERUM OR TISSUE DONORS FOR HCV. ABBOTT REALTIME HCV GENOTYPE II CONTROL KITTHE ABBOTT REALTIME HCV GENOTYPE II CONTROLS ARE USED TO ESTABLISH RUN VALIDITY OF THE ABBOTT REALTIME HCV GENOTYPE II ASSAY WHEN USED FOR DETERMINING THE GENOTYPE(S) OF HEPATITIS C VIRUS (HCV) IN PLASMA OR SERUM FROM INDIVIDUALS CHRONICALLY INFECTED WITH HCV. URACIL-N-GLYCOSYLASE (UNG) THE URACIL-N-GLYCOSYLASE (UNG) PROCEDURE IS TO BE USED IN CONJUNCTION WITH ABBOTT REALTIME HCV GENOTYPE II ASSAY AS AN OPTIONAL CONTAMINATION CONTROL FOR CUSTOMER LABORATORIES THAT ARE CURRENTLY USING OR HAVE PREVIOUSLY USED AMPLIFICATION TECHNOLOGIES THATINCORPORATE URACIL INTO THE AMPLIFICATION PRODUCT.

    Classifications

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

    Product Code Device Name
    OBF Assay, Genotyping, Hepatitis C Virus