BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Kit, Dna Detection, Human Papillomavirus

    PMA: P890064 · Supplement: S006 · Decision Mar 17, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12

    Basic Information

    Device Name
    Kit, Dna Detection, Human Papillomavirus
    Trade Name
    HCII HPV TEST (DIGENE HPV TEST USING HYBRID CAPTURE II TECHNOLOGY)
    PMA Number
    P890064
    Supplement Number
    S006
    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
    March 17, 1999
    Date Received
    September 30, 1997
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for chaning the solid phase on which the RNA:DNA hybrids are captured from polystyrene tubes to a 96-well microtiter place addition of a new cervical specimen collection kit (Digene Cervical Sampler), addition of the Digene Sample Conversion Kit,a nd the addition of new assay performance characteristics. The device, as modified, will be marketed under the trade name Digene HPV Test Using Hybrid Capture(R) II Technology (HCII HPV) witht he following indications: The Digene HPV Test using Hybrid Capture II technology is a nucleic acid signal enhanced solution hybridization microplate assay using chemiluminescence for the qualitative detection of eighteen types of human papillomavirus (HPV) DNA in cervical specimens. The Digene HPV Test can differentiate between two HPV DNA groups: low risk HPV types 6/11/42/43/44; and high/intermediate risk HPV types 16/18/31/33/35/39/45/51/52/56/58/59/68, but cannot determine the specific HPV type present. Cervical specimens which may be tested with the Digene HPV Test include the following: 1) Specimens collected with the Digene Cervical Sampler; 2) Biopsies collected in the Digene Specimen Transport Medium; 3) Specimens collected using a broom-type collection device and placed in Cytye PreservCyt Solution (refer to the Digen Sample Converstion Kit package insert for complete details).

    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