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.
For expanding the indication to aid in the identification of non-small cell lung cancer patients whose tumors harbor kras g12c mutations and may benefit from treatment with lumakras™ (sotorasib).
| Device | therascreen KRAS RGQ PCR KIT |
| Generic Name | Somatic Gene Mutation Detection System |
| Applicant | QIAGEN GmbH |
| Date Received | 2021-02-10 |
| Decision Date | 2021-05-28 |
| PMA | P110027 |
| Supplement | S012 |
| Product Code | OWD |
| Advisory Committee | Pathology |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | QIAGEN GmbH qiagen Strasse 1 hilden 40724 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P110027 | Original Filing | |
| S015 | 2022-06-15 | 30-day Notice |
| S014 | 2022-05-19 | Special (immediate Track) |
| S013 | ||
| S012 | 2021-02-10 | Panel Track |
| S011 | 2020-03-04 | 30-day Notice |
| S010 | 2018-03-08 | 30-day Notice |
| S009 | 2015-08-18 | Normal 180 Day Track No User Fee |
| S008 | 2015-02-18 | Normal 180 Day Track |
| S007 | 2015-01-26 | Real-time Process |
| S006 | 2015-01-26 | Real-time Process |
| S005 | 2015-01-21 | 30-day Notice |
| S004 | 2015-01-21 | 30-day Notice |
| S003 | 2014-12-22 | 30-day Notice |
| S002 | 2014-12-15 | 30-day Notice |
| S001 |