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

    Cytomegalovirus (Cmv) Dna Quantitative Assay

    PMA: P160044 · Decision May 18, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10

    Basic Information

    Device Name
    Cytomegalovirus (Cmv) Dna Quantitative Assay
    Trade Name
    ABBOTT REALTIME CMV
    PMA Number
    P160044
    Device Class
    FDA Class 2
    Product Code
    PAB
    Generic Name
    Cytomegalovirus (cmv) dna quantitative assay
    Regulation Number
    866.3180
    Medical Specialty
    Microbiology
    Advisory Committee
    Microbiology
    Decision
    Approved (Reclassification)
    Decision Code
    APRL
    Decision Date
    May 18, 2017
    Date Received
    October 4, 2016
    Expedited Review
    N
    Docket Number
    17M-3200

    Advisory Committee Statement

    Approval for the Abbott RealTime CMV test is an in vitro polymerase chain reaction (PCR) assay for the quantitation of cytomegalovirus (CMV) DNA in human EDTA plasma. The Abbott RealTime CMV test is intended for use as an aid in the management of Hematopoietic Stem Cell Transplant patients who are undergoing anti-cytomegalovirus therapy. In this population, serial DNA measurement can be used to assess virological response to anti-cytomegalovirus therapy. The results from the RealTime CMV test must be interpreted within the context of all relevant clinical and laboratory findings. The RealTime CMV test is not intended as a screening test for the presence of CMV DNA 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
    PAB Cytomegalovirus (Cmv) Dna Quantitative Assay