BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Kit, Dna Detection, Human Papillomavirus

    PMA: P160037 · Supplement: S004 · Decision Jun 12, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12

    Basic Information

    Device Name
    Kit, Dna Detection, Human Papillomavirus
    Trade Name
    BD Onclarity HPV Assay
    PMA Number
    P160037
    Supplement Number
    S004
    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
    June 12, 2020
    Date Received
    November 7, 2019
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for changes to labeling to include expansion of the assay reporting claims to include additional high-risk HPV genotypes (beyond HPV 16, 18 and 45). The BD Onclarity HPV Assay is a qualitative in vitro test for the detection of Human Papillomavirus in clinician-collected cervical specimens using an endocervical brush/spatula combination or broom and placed in a BD SurePath vial. The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk (HR) HPV types in a single analysis. The test specifically identifies types 16, 18, 31, 45, 51, and 52 while reporting the other HR HPV types in groups (33/58, 35/39/68, and 56/59/66). The BD Onclarity HPV Assay 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.WARNINGThe BD Onclarity HPV Assay is NOT intended:1) For use in determining the need for treatment (i.e., excisional or ablative treatment of the cervix) in the absence of high-grade cervical dysplasia. Patients who are HPV 16, 18 and 45 positive should be assessed for the development of high-grade cervical intraepithelial neoplasia according to current practice guidelines;2) For women who have undergone hysterectomy with removal of the cervix; and3) For use with samples other than those collected by a clinician using an endocervical brush/spatula combination or broom and placed in the BD SurePath Preservative Fluid Collection Vial.HPV-negative cancers of the cervix do occur infrequently. No cancer screening test is 100% sensitive. Use of this device for primary cervical cancer screening should be undertaken after carefully considering the performance characteristics put forth in this label, as well as recommendations of professional guidelines.The use of this test has not been evaluated for the management of women with prior ablative or excisional therapy, or who are pregnant, or below age 21, or for the management of transgender individuals.

    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