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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.
 
DeviceCOBAS HPV TEST
Generic NameKIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
ApplicantRoche Molecular Systems, Inc.
4300 Hacienda Drive
Pleasanton, CA 94588-2722
PMA NumberP100020
Supplement NumberS008
Date Received07/01/2013
Decision Date04/24/2014
Product Code MAQ 
Docket Number 14M-0552
Notice Date 04/24/2014
Advisory Committee Microbiology
Clinical TrialsNCT00709891
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE COBAS® HPV TEST. THE COBAS® HPV TEST INDICATIONS FOR USE: THE COBAS® HPV TEST IS A QUALITATIVE IN VITRO TEST FOR THE DETECTION OF HUMAN PAPILLOMAVIRUS IN CERVICAL SPECIMENS COLLECTED BY A CLINICIAN USING AN ENDOCERVICAL BRUSH/SPATULA AND PLACED IN THE THINPREP® PAP TESTTM PRESERVCYT® SOLUTION. 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 HPV16 AND HPV18 WHILE CONCURRENTLY DETECTING THE REST OF THE HIGH RISK TYPES (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 AND 68).THE COBAS® HHPV 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; 2) TO BE USED IN PATIENTS PLEASE SEE APPROVAL ORDER FOR FURTHER INFORMATION.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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