BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Kit, Rna Detection, Human Papillomavirus

    PMA: P120007 · Decision Oct 12, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Kit, Rna Detection, Human Papillomavirus
    Trade Name
    APTIMA HPV 16 18/45 GENOTYPE ASSAY
    PMA Number
    P120007
    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 12, 2012
    Date Received
    April 19, 2012
    Expedited Review
    N
    Docket Number
    12M-1066

    Advisory Committee Statement

    APPROVAL FOR THE APTIMA HPV 16 18/45 GENOTYPE ASSAY.APTIMA HPV 16 18/45 GENOTYPE ASSAY INDICATIONS FOR USE:THE APTIMA HPV 16 18/45 GENOTYPE ASSAY IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR THE QUALITATIVE DETECTION OF E6/E7 VIRAL MESSENGER RNA (MRNA) OF HUMAN PAPILLOMAVIRUS (HPV) TYPES 16, 18, AND 45 IN CERVICAL SPECIMENS FROM WOMEN WITH APTIMA HPV ASSAY POSITIVERESULTS. THE APTIMA HPV 16 18/45 GENOTYPE ASSAY CAN DIFFERENTIATE HPV 16 FROM HPV 18 AND/OR HPV 45, BUT DOES NOT DIFFERENTIATE BETWEEN HPV 18 AND HPV 45. CERVICAL SPECIMENS IN THINPREP PAP TEST VIALS CONTAINING PRESERVCYT SOLUTION AND COLLECTED WITH BROOM-TYPE ORCYTOBRUSH/SPATULA COLLECTION DEVICES* MAY BE TESTED WITH THE APTIMA HPV 16 18/45 GENOTYPE ASSAY. THE ASSAY IS USED WITH THE TIGRIS DTS SYSTEM. THE USE OF THE TEST IS INDICATED: 1) IN PATIENTS 21 YEARS AND OLDER WITH ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE(ASC-US) CERVICAL CYTOLOGY RESULTS, THE APTIMA HPV 16 18/45 GENOTYPE ASSAY CAN BE USED TO TEST SAMPLES FROM WOMEN WITH APTIMA HPV ASSAY POSITIVE RESULTS TO ASSESS THE PRESENCE OR ABSENCE OF HIGH-RISK HPV GENOTYPES 16, 18, AND/OR 45. THIS INFORMATION, TOGETHER WITH THE PHYSICIAN'S ASSESSMENT OF CYTOLOGY HISTORY, OTHER RISK FACTORS, AND PROFESSIONAL GUIDELINES, MAY BE USED TO GUIDE PATIENT MANAGEMENT. THE RESULTS OF THIS TEST ARE NOT INTENDED TO PREVENT WOMEN FROM PROCEEDING TO COLPOSCOPY; AND 2) IN WOMEN 30 YEARS AND OLDER, THE APTIMA HPV 16 18/45 GENOTYPE ASSAY CAN BE USED TO TEST SAMPLES FROM WOMEN WITH APTIMA HPV ASSAY POSITIVE RESULTS. THE ASSAY RESULTS WI11 BE USED IN COMBINATION WITH CERVICAL CYTOLOGY TO ASSESS THE PRESENCE OR ABSENCE OF HIGH-RISK HPV GENOTYPES 16, 18, AND/OR 45. 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