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    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Kit, Dna Detection, Human Papillomavirus

    PMA: P080014 · 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 HR AND GENFIND DNA EXTRACTION KIT
    PMA Number
    P080014
    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    Approved (Withdrawn)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 THE CERVISTA HPV HR AND GENFIND DNA EXTRACTION KIT. CERVISTA HPV HR INDICATIONS FOR USE: THE CERVISTA HPV HR TEST IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUALITATIVE DETECTION OF DNAFROM 14 HIGH-RISK- HUMAN PAPILLOMAVIRUS (HPV) TYPES (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58,59, 66, AND 68) IN CERVICAL SPECIMENS. THE CERVISTA HPV HR TEST CANNOT DETERMINE THESPECIFIC HPV TYPE PRESENT.THE CERVISTA HPV HR 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. THE CERVISTA HPV HR TEST IS INDICATED:1) TO SCREEN PATIENTS WITH ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE (ASCUS)CERVICAL CYTOLOGY RESULTS TO DETERMINE THE NEED FOR REFERRAL TO COLPOSCOPY.2) IN WOMEN 30 YEARS AND OLDER THE CERVISTA HPV HR TEST CAN BE USED WITH CERVICALCYTOLOGY TO ADJUNCTIVELY SCREEN TO ASSESS THE PRESENCE OR ABSENCE OF HIGH-RISK HPVTYPES. THIS INFORMATION, TOGETHER WITH THE PHYSICIAN'S ASSESSMENT OF CYTOLOGY HISTORY,OTHER RISK FACTORS, AND PROFESSIONAL GUIDELINES, MAY BE USED TO GUIDE PATIENTMANAGEMENT. CERVICAL SPECIMENS THAT MAY BE TESTED WITH THE CERVISTA HPV HR TEST INCLUDE THE FOLLOWINGPRESERVATION SYSTEM COLLECTION MEDIA AND COLLECTION DEVICES:¿ THINPREP PAP TEST PRESERVCYT SOLUTION¿ BROOM-TYPE DEVICE (E.G. ROVERS CERVEX BRUSH, WALLACH PAPETTE), OR ENDOCERVICALBRUSH/SPATULA.GENFIND DNA EXTRACTION KIT INDICATION FOR USE:THE GENFIND DNA EXTRACTION KIT IS INTENDED FOR USE IN THE EXTRACTION OF DNA FROMCERVICAL SPECIMENS COLLECTED IN THINPREP PAP TEST PRESERVCYT SOLUTION FOR TESTINGBY THE CERVISTA HPV HR AND CERVISTA HPV 16/18 TESTS.

    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