BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Kit, Dna Detection, Human Papillomavirus

    PMA: P080015 · Decision Mar 12, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12

    Basic Information

    Device Name
    Kit, Dna Detection, Human Papillomavirus
    Trade Name
    CERVISTA HPV 16/18
    PMA Number
    P080015
    Device Class
    FDA Class 3
    Product Code
    MAQ
    Generic Name
    KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
    Medical Specialty
    Unknown
    Advisory Committee
    Microbiology
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    March 12, 2009
    Date Received
    April 28, 2008
    Expedited Review
    N
    Docket Number
    09M-0299

    Advisory Committee Statement

    APPROVAL FOR THECERVISTA HPV 16/18.CERVISTA HPV 16/18 INDICATIONS FOR USE:THE CERVISTA HPV 16/18 TEST IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUALITATIVE DETECTION OF DNA FROM HUMAN PAPILLOMAVIRUS (HPV) TYPE 16 AND TYPE 18 IN CERVICAL SPECIMENS.THE CERVISTA HPV 16/18 TEST USES THE INVADER CHEMISTRY, A SIGNAL AMPLIFICATION METHOD FORDETECTION OF SPECIFIC NUCLEIC ACID SEQUENCES. THIS METHOD USES TWO TYPES OF ISOTHERMAL REACTIONS:A PRIMARY REACTION THAT OCCURS ON THE TARGETED DNA SEQUENCE AND A SECONDARY REACTION THAT PRODUCES A FLUORESCENT SIGNAL.CERVISTA HPV 16/18 TEST IS INDICATED:1) IN WOMEN 30 YEARS AND OLDER THE CERVISTA HPV 16/1S TEST CAN BE USED ADJUNCTIVELYWITH THE CERVISTA HPV HR TEST IN COMBINATION WITH CERVICAL CYTOLOGY TO SCREEN TO ASSESS THE PRESENCE OR ABSENCE OF HIGH-RISK HPV TYPES 16 AND 18. THIS INFORMATION,TOGETHER WITH THE PHYSICIAN'S ASSESSMENT OF CYTOLOGY HISTORY, OTHER RISK FACTORS, AND PROFESSIONAL GUIDELINES, MAY BE USED TO GUIDE PATIENT MANAGEMENT. 2) TO BE USED ADJUNCTIVELY WITH THE CERVISTA HPV HR TEST IN PATIENTS WITH ATYPICALSQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE (ASC-US) CERVICAL CYTOLOGY RESULTS, TOASSESS THE PRESENCE OR ABSENCE OF HIGH-RISK HPV TYPES 16 AND 18. 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.CERVICAL SPECIMENS THAT MAY BE TESTED WITH THE CERVISTA HPV 16/18 TEST INCLUDE THE FOLLOWINGPRESERVATION SYSTEM AND COLLECTION DEVICES:THINPREP PAP TEST PRESERVCYT SOLUTION; AND¿ BROOM-TYPE DEVICE (E.G. ROVERS CERVEX BRUSH, WALLACH PAPETTE), OR ENDOCERVICALBRUSH/SPATULA.

    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