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.
The cobas® kras mutation test, for use with the cobas® 4800 system, is a real-time pcr test for the detection of mutations in codons 12, 13 and 61 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 who should not be treated with erbitux® (cetuximab) or with vectibix® (panitumumab) when kras codon 12 or 13 mutation is detected. Safety and efficacy of erbitux® (cetuximab) or vectibix® (panitumumab) have not been established in patients whose tumors have codon 61 mutation. 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 | 2016-02-29 |
| Decision Date | 2016-09-24 |
| PMA | P140023 |
| Supplement | S004 |
| Product Code | OWD |
| Advisory Committee | Pathology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Roche Molecular Systems, Inc. 4300 Hacienda Drive pleasanton, CA 94588-2722 |
| 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 |