BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Kit, Rna Detection, Human Papillomavirus

    PMA: P100042 · Decision Oct 28, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Kit, Rna Detection, Human Papillomavirus
    Trade Name
    APTIMA HPV ASSAY
    PMA Number
    P100042
    Device Class
    FDA Class 3
    Product Code
    OYB
    Generic Name
    Kit, rna detection, human papillomavirus
    Medical Specialty
    Unknown
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 28, 2011
    Date Received
    November 5, 2010
    Expedited Review
    N
    Docket Number
    11M-0792

    Advisory Committee Statement

    APPROVAL FOR THE APTIMA HPV ASSAY.APTIMA HPV ASSAY INDICATIONS FOR USE:THE APTIMA HPV ASSAY IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR THE QUALITATIVE DETECTIONOFE6/E7 VIRAL MESSENGER RNA (MRNA) FROM 14 HIGH-RISK TYPES OF HUMAN PAPILLOMAVIRUS (HPV) IN CERVICAL SPECIMENS. THE HIGH-RISK HPV TYPES DETECTED BY THE ASSAY INCLUDE: 16, 18,31,33,35, 39,45,51,52,56,58,59,66, AND 68. THE APTIMA HPV ASSAY DOES NOT DISCRIMINATE BETWEEN THE14 HIGH-RISK TYPES. CERVICAL SPECIMENS IN THINPREP PAP TEST VIALS CONTAINING PRESERVCYT SOLUTIONAND COLLECTED WITH BROOM-TYPE OR CYTOBRUSH/ SPATULA COLLECTION DEVICES* MAY BE TESTED WITH THEAPTIMA HPV ASSAY. THE ASSAY IS USED WITH THE TIGRIS DTS SYSTEM. THE USE OF THE TEST IS INDICATED:I. TO SCREEN PATIENTS 21 YEARS AND OLDER WITH ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE (ASC-US) CERVICAL CYTOLOGY RESULTS TO DETERMINE THE NEED FOR REFERRAL TO COLPOSCOPY. THE RESULTS OF THIS TEST ARE NOT INTENDED TO PREVENT WOMEN FROM PROCEEDING TOCOLPOSCOPY. 2. IN WOMEN 30 YEARS AND OLDER, THE APTIMA HPV ASSAY CAN BE USED WITH CERVICAL CYTOLOGYTO ADJUNCTIVELY SCREEN TO ASSESS THE PRESENCE OR ABSENCE OF HIGH-RISK HPV TYPES. THIS INFORMATION, TOGETHER WITH THE PHYSICIAN'S ASSESSMENT OF CYTOLOGY HISTORY, OTHER RISK FACTORS, AND PROFESSIONAL GUIDELINES, MAY BE USED TO GUIDE PATIENT MANAGEMENT.* BROOM-TYPE DEVICE (E.G., WALLACH PIPETTE) OR ENDOCERVICAL BRUSH/SPATULA.

    Classifications

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

    Product Code Device Name
    OYB Kit, Rna Detection, Human Papillomavirus