BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Kit, Dna Detection, Human Papillomavirus

    PMA: P080014 · Supplement: S007 · Decision Dec 12, 2011
    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 HIGH-THROUGHPUT AUTOMATION
    PMA Number
    P080014
    Supplement Number
    S007
    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
    December 12, 2011
    Date Received
    April 27, 2011
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MIGRATION OF THE CERVISTA HPV HR MANUAL ASSAY TO AN AUTOMATED PLATFORM HIGH-THROUGHPUT AUTOMATION. THE DEVICE, AS MODIFIED, WILL BE MARKED UNDER TRADE NAME CERVISTA HPV HR HIGH-THROUGHPUT AUTOMATION AND IS INDICATED FOR:THE CERVISTA HPV HR TEST IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUALITATIVE DETECTION OF DNA FROM 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 THE SPECIFIC HPV TYPE PRESENT. THE CERVISTA HPV HR TEST USES THE INVADER CHEMISTRY, A SIGNAL AMPLIFICATION METHOD FOR DETECTION 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 COLOSTOMY; AND 2) IN WOMEN 30 YEARS AND OLDER THE CERVISTA HPV HR TEST CAN BE USED WITH CERVICAL CYTOLOGY TO 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. CERVICAL SPECIMENS THAT MAY BE TESTED WITH THE CERVISTA HPV HR TEST INCLUDE THE FOLLOWING PRESERVATION SYSTEM COLLECTION MEDIA AND COLLECTION DEVICES:¿ THINPREP PAP TEST PRESERVCYT SOLUTION¿ BROOM-TYPE DEVICE (E.G., ROVERS CERVEX BRUSH, WALLACH PAPETTE), OR ENDOCERVICAL BRUSH/SPATULA.THE CERVISTA HPV HR TEST MAY BE PERFORMED EITHER MANUALLY OR USING THE AUTOMATED CERVISTA HIGH-THROUGHPUT AUTOMATION SYSTEM. (CORRECTED STATEMENT NEEDS TO BE ADDED TO DATABASE.)

    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