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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.
 
DeviceROCHE COBAS HPV TEST
Generic NameKIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
ApplicantRoche Molecular Systems, Inc.
4300 Hacienda Drive
Pleasanton, CA 94588-2722
PMA NumberP100020
Supplement NumberS004
Date Received04/02/2012
Decision Date06/25/2013
Product Code MAQ 
Advisory Committee Microbiology
Clinical TrialsNCT00709891
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR PROCESSING OF RESIDUAL CERVICAL SAMPLE DIRECTLY FROM THE PRESERVCYT¿ VIAL (HOLOGIC, INC., BEDFORD, MA) AFTER PROCESSING FOR LIQUID-BASED CYTOLOGY (LBC) USING EITHER THE HOLOGIC THINPREP® 2000 OR THINPREP® 3000 PROCESSORS AND TESTING ON THE COBAS® 4800 SYSTEM DIRECTLY FROM THE PRESERVCYT VIAL (PRIMARY VIAL). APPROVAL FOR CAPABILITY TOADD OPTIONAL NON-IVD SOFTWARE TO THE COBAS® 4800 SYSTEM THAT IS USED TO PERFORM THE COBAS® HPV TEST WAS ALSO REQUESTED.
Post-Approval StudyShow Report Schedule and Study Progress
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