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

    Cytomegalovirus (Cmv) Dna Quantitative Assay

    PMA: P210022 · Decision May 5, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10

    Basic Information

    Device Name
    Cytomegalovirus (Cmv) Dna Quantitative Assay
    Trade Name
    Alinity m CMV
    PMA Number
    P210022
    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 5, 2022
    Date Received
    June 1, 2021
    Expedited Review
    N
    Docket Number
    22M-0773

    Advisory Committee Statement

    Approval for Alinity m CMV. Alinity m CMV AMP KitThe Alinity m CMV assay is an in vitro polymerase chain reaction (PCR) assay for use with the automated Alinity m System to quantitate cytomegalovirus (CMV) DNA in human EDTA plasma. The Alinity m CMV assay is intended for use as an aid in the management of Hematopoietic Stem Cell Transplant and Solid Organ Transplant patients who are undergoing anti-cytomegalovirus therapy. The Alinity m CMV assay can be used to assess virological response to anti-cytomegalovirus therapy. The results from the Alinity m CMV test must be interpreted within the context of all relevant clinical and laboratory findings. The Alinity m CMV test is not intended as a screening test for the presence of CMV DNA in blood or blood products.Alinity m CTRL KitThe Alinity m CMV controls are for validity determination of the quantitative Alinity m CMV assay on the automated Alinity m System. These controls are intended to be used with the Alinity m CMV assay; refer to the assay package insert for additional information.Alinity m CAL KitThe Alinity m CMV calibrators are for calibration for the Alinity m CMV assay on the automated Alinity m System when used for the quantitative determination of CMV DNA. The calibrators are intended to be used with the Alinity m CMV assay; refer to the assay package insert for additional information.

    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