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: P160023 · Decision Feb 13, 2017
    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
    APTIMA HCV QUANT DX ASSAY
    PMA Number
    P160023
    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
    February 13, 2017
    Date Received
    July 8, 2016
    Expedited Review
    N
    Docket Number
    17M-0971

    Advisory Committee Statement

    Approval for the Aptima HCV Quant Dx. This device is indicated for: The Aptima HCV Quant Dx Assay is a real-time transcription mediated amplification test (TMA) used for both detection and quantitation of hepatitis C virus (HCV) RNA in fresh and frozen human serum and plasma from HCV-infected individuals. Plasma may be prepared in ethylenediaminetetraacetic acid (EDTA), anticoagulant citrate dextrose (ACD) solution, and plasma preparation tubes (PPT). Serum may be prepared in serum tubes and serum separator tubes (SST). Specimens are tested using the Panther system for automated specimen processing, amplification, detection, and quantitation. Specimens containing HCV genotypes 1 to 6 are validated for detection and quantitation in the assay. The Aptima HCV Quant Dx Assay is indicated for use as an aid in the diagnosis of active HCV infection in the following populations: individuals with antibody evidence of HCV infection with evidence of liver disease, individuals suspected to be actively infected with HCV antibody evidence, and individuals at risk for HCV infection with antibodies to HCV. Detection of HCV RNA indicates that the virus is replicating and, therefore, is evidence of active infection. Detection of HCV RNA does not discriminate between acute and chronic state of infection. The Aptima HCV Quant Dx Assay is also indicated for use as an aid in the management of HCV infected patients undergoing HCV antiviral drug therapy. The assay can be used to measure HCV RNA levels periodically prior to, during, and after treatment to determine sustained virological response (SVR) or nonsustained virological response (NSVR). Assay performance characteristics have been established for individuals infected with HCV and treated with certain direct acting antiviral agents (DAA) regimens. No information is available on the assay’s predictive value when other therapies are used. The results from the Aptima HCV Quant Dx Assay must be interpreted within the context of all relevant clinical and laboratory findings. The Aptima HCV Quant Dx Assay is not approved for use as a screening test for the presence of HCV RNA in blood or blood products.

    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