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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCERVISTA HPV HR HIGH-THROUGHPUT AUTOMATION
Generic NameKIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
ApplicantHOLOGIC, INC.
250 CAMPUS DRIVE
MARLBOROUGH, MA 01750
PMA NumberP080014
Supplement NumberS007
Date Received04/27/2011
Decision Date12/12/2011
Withdrawal Date 04/19/2023
Product Code MAQ 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order 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.)
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