BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Hepatitis Viral B Dna Detection

    PMA: P170025 · Decision Jan 23, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Hepatitis Viral B Dna Detection
    Trade Name
    Aptima HBV Quant Assay
    PMA Number
    P170025
    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
    January 23, 2018
    Date Received
    July 31, 2017
    Expedited Review
    N
    Docket Number
    18M-0411

    Advisory Committee Statement

    Approval for the Aptima HBV Quant assay is an in vitro nucleic acid amplification test for the quantitation of hepatitis B virus (HBV) DNA in human plasma and serum on the fully automated Panther® system.Plasma may be prepared in ethylenediaminetetraacetic acid (EDTA), anticoagulant citrate dextrose (ACD) solution, and plasma preparation tubes (PPTs). Serum may be prepared inserum tubes and serum separator tubes (SSTs). Specimens are tested using the fullyautomated Panther system for sample processing, amplification, and quantitation. Specimenscontaining HBV genotypes A, B, C, D, E, F, G, and H are validated for quantitation in the assay.The Aptima HBV Quant assay is intended for use as an aid in the management of patientswith chronic HBV infections undergoing HBV antiviral drug therapy. The assay can be usedto measure HBV DNA levels at baseline and during treatment to aid in assessing viralresponse to treatment. The results from the Aptima HBV Quant assay must be interpretedwithin the context of all relevant clinical and laboratory findings. Assay performance fordetermining the clinical stage of HBV infection has not been established. Clinicalperformance characteristics have been established for individuals treated with tenofovirdisoproxil fumarate or entecavir.The Aptima HBV Quant assay is not approved for use as a screening test for the presenceof HBV DNA in blood or blood products or as a diagnostic test to confirm the presence ofHBV 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