BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Kit, Dna Detection, Human Papillomavirus

    PMA: P190028 · Decision Apr 3, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12

    Basic Information

    Device Name
    Kit, Dna Detection, Human Papillomavirus
    Trade Name
    cobas HPV for use on the cobas 6800/8800 Systems
    PMA Number
    P190028
    Device Class
    FDA Class 3
    Product Code
    MAQ
    Generic Name
    KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
    Medical Specialty
    Unknown
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 3, 2020
    Date Received
    October 7, 2019
    Expedited Review
    N
    Docket Number
    20M-1213

    Advisory Committee Statement

    Approval for the cobas HPV for use on the cobas 6800/8800 Systems. cobas HPV for use on the cobas 6800/8800 Systems (cobas HPV) is a qualitative in vitro test for the detection of Human Papillomavirus in clinician-collected cervical specimens using an endocervical brush/spatula or broom and placed in the ThinPrep Pap Test PreservCyt Solution. This test detects the high-risk HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. cobas HPV is indicated for use for routine cervical cancer screening as per professional medical guidelines, including triage of ASC-US cytology, co-testing (or adjunctive screen) with cytology, and HPV primary screening of women to assess the risk for cervical precancer and cancer. Patients should be followed-up in accordance with professional medical guidelines, results from prior screening, medical history, and other risk factors.

    Classifications

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

    Product Code Device Name
    MAQ Kit, Dna Detection, Human Papillomavirus