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.
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.
| Device | ROCHE COBAS HPV TEST |
| Classification Name | Kit, Dna Detection, Human Papillomavirus |
| Generic Name | Kit, Dna Detection, Human Papillomavirus |
| Applicant | Roche Molecular Systems, Inc. |
| Date Received | 2012-04-02 |
| Decision Date | 2013-06-25 |
| PMA | P100020 |
| Supplement | S004 |
| Product Code | MAQ |
| Advisory Committee | Microbiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Roche Molecular Systems, Inc. 4300 Hacienda Drive pleasanton, CA 94588-2722 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P100020 | Original Filing | |
| S054 | 2022-10-21 | 30-day Notice |
| S053 | 2020-07-27 | 30-day Notice |
| S052 | 2020-06-01 | 30-day Notice |
| S051 | 2020-04-17 | 30-day Notice |
| S050 | 2019-09-20 | 30-day Notice |
| S049 | ||
| S048 | 2019-08-08 | 30-day Notice |
| S047 | 2019-04-24 | 30-day Notice |
| S046 | 2019-04-10 | 30-day Notice |
| S045 | 2019-04-08 | 30-day Notice |
| S044 | 2019-04-03 | 30-day Notice |
| S043 | 2019-02-04 | 30-day Notice |
| S042 | 2018-12-14 | 30-day Notice |
| S041 | 2018-11-13 | 30-day Notice |
| S040 | 2018-11-09 | 30-day Notice |
| S039 | 2018-10-25 | 30-day Notice |
| S038 | 2018-08-21 | 30-day Notice |
| S037 | 2018-07-27 | 30-day Notice |
| S036 | 2018-06-29 | 30-day Notice |
| S035 | 2018-06-08 | 30-day Notice |
| S034 | 2018-06-04 | 30-day Notice |
| S033 | 2018-05-23 | 30-day Notice |
| S032 | 2018-05-09 | Real-time Process |
| S031 | 2018-05-04 | 30-day Notice |
| S030 | 2018-04-16 | 30-day Notice |
| S029 | 2018-03-01 | 30-day Notice |
| S028 | 2017-12-07 | 30-day Notice |
| S027 | 2017-10-30 | 30-day Notice |
| S026 | 2017-09-26 | 30-day Notice |
| S025 | 2017-07-28 | Normal 180 Day Track |
| S024 | 2017-07-17 | 30-day Notice |
| S023 | 2017-07-14 | 30-day Notice |
| S022 | 2017-07-14 | 30-day Notice |
| S021 | 2016-09-22 | 30-day Notice |
| S020 | 2016-07-08 | 30-day Notice |
| S019 | 2016-04-18 | 30-day Notice |
| S018 | 2016-04-07 | 30-day Notice |
| S017 | 2015-12-23 | Panel Track |
| S016 | ||
| S015 | 2015-06-24 | 30-day Notice |
| S014 | 2015-03-13 | 30-day Notice |
| S013 | 2015-02-25 | Real-time Process |
| S012 | 2013-11-05 | Real-time Process |
| S011 | 2013-08-14 | 30-day Notice |
| S010 | 2013-08-09 | 30-day Notice |
| S009 | 2013-07-26 | 30-day Notice |
| S008 | 2013-07-01 | Panel Track |
| S007 | 2012-10-09 | 30-day Notice |
| S006 | 2012-08-15 | 30-day Notice |
| S005 | 2012-07-02 | Real-time Process |
| S004 | 2012-04-02 | Normal 180 Day Track |
| S003 | 2012-03-29 | Normal 180 Day Track No User Fee |
| S002 | 2011-12-12 | 135 Review Track For 30-day Notice |
| S001 | 2011-05-31 | Normal 180 Day Track No User Fee |