BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Hepatitis Viral B Dna Detection

    PMA: P200013 · Supplement: S011 · Decision Dec 22, 2022
    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
    Supplement Number
    S011
    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
    December 22, 2022
    Date Received
    December 7, 2022
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for addition to Limitations of the Procedure: Unexpected HBV DNA levels due to carry over may occur. If results are inconsistent with patient history and other diagnostics through patient monitoring, a retest of the sample should be considered by the physician or healthcare provider. Approval is also for the following change to the Specific Performance Characteristic – Carryover section: The carryover rate for Alinity m HBV was determined in two studies. Study 1 evaluated the carryover rate in the Sample Input Rack and Sample Processing Unit by analyzing 360 valid replicates of HBV negative samples processed from alternating positions in the sample input rack with 360 valid replicates of high concentrated HBV positive samples at 100,000,000 IU/mL, across multiple runs. HBV DNA was not detected in any of the HBV negative samples, resulting in a carryover rate of 0% (95% CI: 0.0 to 1.1%). Study 2 evaluated the carryover rate in the AMP tray by evaluating 414 valid replicates of HBV negative samples processed from alternating positions at the AMP Tray with 414 valid replicates of high concentrated HBV positive samples at 100,000,000 IU/mL across multiple runs. HBV DNA was detected in 16 of the HBV negative samples resulting in a carryover rate of 3.9% (95% CI: 2.2 to 6.2%).

    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