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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.
 
DeviceCOBAS HPV TEST
Generic NameKIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
ApplicantRoche Molecular Systems, Inc.
4300 Hacienda Drive
Pleasanton, CA 94588-2722
PMA NumberP100020
Date Received06/01/2010
Decision Date04/19/2011
Product Code MAQ 
Docket Number 11M-0300
Notice Date 05/06/2011
Advisory Committee Microbiology
Clinical TrialsNCT00709891
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE COBAS HPV TEST. COBAS HPV TEST INDICATIONS FOR USE: THE COBAS HPV TEST IS A QUALITATIVE IN VITRO TEST FOR THE DETECTION OF HUMAN PAPILLOMAVIRUS (HPV) IN PATIENT SPECIMENS. THE TEST UTILIZES AMPLIFICATION OF TARGET DNA BY THE POLYMERASE CHAIN REACTION (PCR) AND NUCLEIC ACID HYBRIDIZATION FOR THE DETECTION OF 14 HIGH-RISK (HR) HPV TYPES IN A SINGLE ANALYSIS. THE TEST SPECIFICALLY IDENTIFIES TYPES HPV 16 AND HPV 18 WHILE CONCURRENTLY DETECTING THE REST OF THE REST OF THE HIGH RISK TYPES (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 AND 68). THE COBAS HPV TEST IS INDICATED: 1) TO SCREEN PATIENTS 21 YEARS AND OLDER WITH ASC-US (ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE) CERVICAL CYTOLOGY TEST RESULTS TO DETERMINE THE NEED FOR REFERRAL TO COLPOSCOPY; AND 2) TO BE USED IN PATIENTS 21 YEARS AND OLDER WITH ASC-US CERVICAL CYTOLOGY RESULTS, TO ASSESS THE PRESENCE OR ABSENCE OF HIGH-RISK HPV GENOTYPES 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; 3) IN WOMEN 30 YEARS AND OLDER, THE COBAS HPV 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; AND 4) IN WOMEN 30 YEARS AND OLDER, THE COBAS HPV TEST CAN BE USED TO ASSESS THE PRESENCE OR ABSENCE OF HPV GENOTYPES 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....(SEE APPROVAL ORDER FOR ADDITIONAL APPROVAL STATEMENT DETAIL).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S003 S004 S017 S019 S020 S002 S012 S015 S013 S014 
S006 S007 S005 S008 S009 S010 S011 S021 S018 S022 S023 S024 
S037 S038 S027 S029 S048 S051 S044 S045 S046 S047 S025 S031 
S032 S033 S034 S028 S030 S026 S035 S036 S040 S041 S042 S052 
S043 S049 S050 S039 S053 S054 S058 S059 S056 S057 
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