This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the cobas® egfr mutation test. The cobas® egfr mutation test is a real-time pcr test for the qualitative detection of exon 19 deletions and exon 21 (l858r) substitution mutations ofthe epidermal growth factor receptor (egfr) gene in dna derived from formalin-fixed paraffin-embedded (ffpet) human non-small cell lung cancer (nsclc) tumor tissue. The test is intended to be used as an aid in selecting patients with metastatic nsclc for whom tarceva® (erlotinib), an egfr tyrosine kinase inhibitor (tk1), is indicated. Specimens are processed using the cobas® dna sample preparation kit for manual sample preparation and the cobas z 480 analyzer for automated amplification and detection.
| Device | COBAS EGFR MUTATION TEST |
| Classification Name | Somatic Gene Mutation Detection System |
| Generic Name | Somatic Gene Mutation Detection System |
| Applicant | ROCHE |
| Date Received | 2012-11-08 |
| Decision Date | 2013-05-14 |
| Notice Date | 2013-05-17 |
| PMA | P120019 |
| Supplement | S |
| Product Code | OWD |
| Docket Number | 13M-0594 |
| Advisory Committee | Pathology |
| 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 |