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 the cobas® egfr mutation test v2. This device is indicated for:the cobas® egfr mutation test v2 is a real-time pcr test for the qualitative detection of defined mutations of the epidermal growth factor receptor (egfr) gene in dna derived from formalin-fixed paraffin-embedded tumor tissue (ffpet) from non-small cell lung cancer (nsclc) patients. The test is intended to aid in identifying patients with nsclc whose tumors have defined egfr mutations and for whom safety and efficacy of a drug have been established as follows: tarceva® (erlotinib)/exon 19 deletions and l858r and tagrisso® (osimertinib) t790m. Drug safety and efficacy have not been established for the following egfr mutations also detected by the cobas® egfr mutation test v2: tarceva® (erlotinib)/g719x, exon 20 insertions, t790m, s768i and l861q/tagrisso® (osimertinib)/g719x, exon 19 deletions, l858r, exon 20 insertions, s768i, and l861q. For manual sample preparation, ffpet specimens are processed using the cobas® dna sample preparation kit and the cobas z 480 analyzer is used for automated amplification and detection.
| Device | COBAS EGFR MUTATION TEST V2 |
| Classification Name | Somatic Gene Mutation Detection System |
| Generic Name | Somatic Gene Mutation Detection System |
| Applicant | ROCHE |
| Date Received | 2015-05-28 |
| Decision Date | 2015-11-13 |
| Notice Date | 2015-11-30 |
| PMA | P120019 |
| Supplement | S007 |
| Product Code | OWD |
| Docket Number | 15M-4344 |
| Advisory Committee | Pathology |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | ROCHE 4300 Hacienda Drive po Box 9002 pleasanton, CA 94588 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| 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 |