BEUDAMED
    Product Code: QBB FDA class 3

    Placental Alpha Microglobulin-1 Immunoassay

    Unknown

    The Placental Alpha Microglobulin-1 Immunoassay is a qualitative test intended to detect the presence of placental alpha microglobulin-1 (PAMG-1) in cervicovaginal secretions as an aid to assess the risk of spontaneous preterm delivery within seven days from the time of sample collection in pregnant women with signs and symptoms of early preterm labor. It is classified as a Class 3 device requiring Premarket Approval (PMA) due to the high-risk nature of its intended use in predicting preterm birth; no regulation number has been assigned. The product code is QBB, reviewed by the Clinical Toxicology (TX) panel. It is not an implant and is not life-sustaining.

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    510(k)s
    0
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    QBB
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    TX
    Submission Type
    2

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    A Placental Alpha Microglobulin-1 Immunoassay is a qualitative test intended to detect the presence of placental alpha microglobulin 1 (PAMG-1) in cervicovaginal secretions. The test is indicated as an aid to assess the risk of spontaneous preterm delivery in less than or equal to 7 days from the time of cervicovaginal sample collection in pregnant women with signs and symptoms of early preterm labor.

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.