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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceCERVISTA HPV 16/18
Generic NameKIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
ApplicantHOLOGIC, INC.
250 Campus Drive
Marlborough, MA 01752
PMA NumberP080015
Date Received04/28/2008
Decision Date03/12/2009
Withdrawal Date 04/19/2023
Product Code MAQ 
Docket Number 09M-0299
Notice Date 06/30/2009
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Approval Order 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.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 
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