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 changes to the cobas 4800 sr2 system software architecture and assay specific analysis package (asap) software for the cobas braf v600 mutation test and cobas egfr mutation test.
| Device | COBAS EGFR MUTATION TEST |
| Classification Name | Somatic Gene Mutation Detection System |
| Generic Name | Somatic Gene Mutation Detection System |
| Applicant | ROCHE |
| Date Received | 2013-12-13 |
| Decision Date | 2014-03-12 |
| PMA | P120019 |
| Supplement | S004 |
| Product Code | OWD |
| Advisory Committee | Pathology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ROCHE 4300 Hacienda Drive po Box 9002 pleasanton, CA 94588 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P120019 | Original Filing | |
| S034 | 2022-10-21 | 30-day Notice |
| S033 | ||
| S032 | 2020-07-27 | 30-day Notice |
| S031 | ||
| S030 | 2019-09-20 | 30-day Notice |
| S029 | 2019-06-27 | Real-time Process |
| S028 | 2019-04-24 | 30-day Notice |
| S027 | ||
| S026 | 2018-11-13 | 30-day Notice |
| S025 | 2018-11-09 | 30-day Notice |
| S024 | 2018-08-21 | 30-day Notice |
| S023 | 2018-07-27 | 30-day Notice |
| S022 | 2018-06-08 | 30-day Notice |
| S021 | 2018-06-04 | 30-day Notice |
| S020 | 2018-03-01 | 30-day Notice |
| S019 | 2018-02-23 | Normal 180 Day Track |
| S018 | 2017-11-30 | Normal 180 Day Track |
| S017 | 2017-10-30 | 30-day Notice |
| S016 | 2017-10-27 | Normal 180 Day Track |
| S015 | 2017-09-26 | 30-day Notice |
| S014 | 2017-07-17 | 30-day Notice |
| S013 | 2017-07-14 | 30-day Notice |
| S012 | 2016-09-22 | 30-day Notice |
| S011 | 2016-08-22 | 30-day Notice |
| S010 | 2016-07-08 | 30-day Notice |
| S009 | 2016-04-18 | 30-day Notice |
| S008 | 2015-06-24 | 30-day Notice |
| S007 | 2015-05-28 | Panel Track |
| S006 | 2015-03-13 | 30-day Notice |
| S005 | 2014-12-19 | 30-day Notice |
| S004 | 2013-12-13 | Real-time Process |
| S003 | 2013-08-14 | 30-day Notice |
| S002 | 2013-08-09 | 30-day Notice |
| S001 | 2013-07-26 | 30-day Notice |