BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Placental Alpha Microglobulin-1 Immunoassay

    PMA: P160052 · Decision Apr 11, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Placental Alpha Microglobulin-1 Immunoassay
    Trade Name
    PartoSure test
    PMA Number
    P160052
    Device Class
    FDA Class 3
    Product Code
    QBB
    Generic Name
    Placental alpha microglobulin-1 immunoassay
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Toxicology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 11, 2018
    Date Received
    November 30, 2016
    Expedited Review
    N
    Docket Number
    18M-1581

    Advisory Committee Statement

    Approval for the PartoSure test. The device is a rapid, qualitative test for detecting the presence of placental alpha microglobulin 1 (PAMG-1) in cervicovaginal secretions. The device is indicated as an aid to rapidly assess the risk of spontaneous preterm delivery in <= 7 days from the time of cervicovaginal sample collection in pregnant women with signs and symptoms of early preterm labor, intact amniotic membranes and minimal cervical dilatation (<3 cm), sampled between 24 weeks, 0 days and 34 weeks, 6 days gestation in women with a singleton gestation.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QBB Placental Alpha Microglobulin-1 Immunoassay