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. |
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Device | ROCHE COBAS HPV TEST |
Generic Name | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS |
Applicant | Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588-2722 |
PMA Number | P100020 |
Supplement Number | S004 |
Date Received | 04/02/2012 |
Decision Date | 06/25/2013 |
Product Code |
MAQ |
Advisory Committee |
Microbiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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. |
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