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 kras mutation test. This device is indicated for the following:the cobas kras mutation test, for use with the cobas 4800 system, is a real-time pcr test for the detection of seven somatic mutations in codons 12 and 13 of the kras gene in dna derived from formalin-fixed paraffin-embedded human colorectal cancer (crc) tumor tissue. The test is intended to be used as an aid in the identification of crc patients for whom treatment with erbitux (cetuximab) or with vectibix (panitumumab) may be indicated based on a no mutation detected result. 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 KRAS MUTATION TEST |
| Classification Name | Somatic Gene Mutation Detection System |
| Generic Name | Somatic Gene Mutation Detection System |
| Applicant | Roche Molecular Systems, Inc. |
| Date Received | 2014-10-23 |
| Decision Date | 2015-05-07 |
| Notice Date | 2015-05-18 |
| PMA | P140023 |
| Supplement | S |
| Product Code | OWD |
| Docket Number | 15M-1708 |
| Advisory Committee | Pathology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Roche Molecular Systems, Inc. 4300 Hacienda Drive pleasanton, CA 94588-2722 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P140023 | Original Filing | |
| S025 | 2022-10-21 | 30-day Notice |
| S024 | ||
| S023 | 2020-07-27 | 30-day Notice |
| S022 | 2020-02-18 | Real-time Process |
| S021 | 2019-09-20 | 30-day Notice |
| S020 | 2019-04-24 | 30-day Notice |
| S019 | 2018-11-13 | 30-day Notice |
| S018 | 2018-11-09 | 30-day Notice |
| S017 | 2018-08-21 | 30-day Notice |
| S016 | 2018-07-27 | 30-day Notice |
| S015 | 2018-06-08 | 30-day Notice |
| S014 | 2018-06-04 | 30-day Notice |
| S013 | 2018-03-01 | 30-day Notice |
| S012 | 2017-10-30 | 30-day Notice |
| S011 | 2017-09-27 | 30-day Notice |
| S010 | 2017-07-17 | 30-day Notice |
| S009 | 2017-07-14 | 30-day Notice |
| S008 | 2016-09-22 | 30-day Notice |
| S007 | 2016-08-22 | 30-day Notice |
| S006 | 2016-07-08 | 30-day Notice |
| S005 | 2016-04-18 | 30-day Notice |
| S004 | 2016-02-29 | Normal 180 Day Track |
| S003 | 2016-01-28 | Real-time Process |
| S002 | 2015-09-02 | 30-day Notice |
| S001 | 2015-06-24 | 30-day Notice |