BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Hepatitis Viral B Dna Detection

    PMA: P200013 · Decision Aug 29, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Hepatitis Viral B Dna Detection
    Trade Name
    Alinity m HBV
    PMA Number
    P200013
    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
    August 29, 2020
    Date Received
    March 2, 2020
    Expedited Review
    N
    Docket Number
    20M-1830

    Advisory Committee Statement

    Approval for the Alinity m HBV. The Alinity m HBV assay is an in vitro polymerase chain reaction (PCR) with fluorescent labeled probes assay for use with the automated Alinity m System to quantitate Hepatitis B Virus (HBV) DNA in human plasma and serum. The Alinity m HBV assay is intended for use as an aid in the management of patients with chronic HBV infection undergoing anti-viral therapy. The assay can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment. The results from the Alinity m HBV assay must be interpreted within the context of all relevant clinical and laboratory findings.This assay is not intended to be used in screening blood, blood products, or cell, tissue, and cellular and tissue-based products (HCT/Ps), or as a diagnostic test to confirm 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