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 extending the labeling claim of the therascreen® egfr rgq pcr kit to include detection of egfr mutations l861q, g719x and s768i, to aid in identifying patients with nsclc for whom safety and efficacy of gilotrif® (afatininb) has been established.
| Device | Therascreen EGFR RGQ PCR Kit |
| Classification Name | Somatic Gene Mutation Detection System |
| Generic Name | Somatic Gene Mutation Detection System |
| Applicant | QIAGEN MANCHESTER LTD |
| Date Received | 2017-07-28 |
| Decision Date | 2018-01-12 |
| PMA | P120022 |
| Supplement | S016 |
| Product Code | OWD |
| Advisory Committee | Pathology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | QIAGEN MANCHESTER LTD skelton House lloyd Street North manchester M15 6 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P120022 | Original Filing | |
| S022 | 2020-10-23 | Real-time Process |
| S021 | 2020-03-04 | 30-day Notice |
| S020 | 2019-08-28 | Special (immediate Track) |
| S019 | 2018-03-08 | 30-day Notice |
| S018 | 2018-02-16 | Normal 180 Day Track |
| S017 | 2018-01-26 | 30-day Notice |
| S016 | 2017-07-28 | Normal 180 Day Track |
| S015 | 2017-06-29 | 30-day Notice |
| S014 | 2016-12-28 | Normal 180 Day Track |
| S013 | 2016-08-10 | 30-day Notice |
| S012 | 2015-09-28 | Normal 180 Day Track No User Fee |
| S011 | ||
| S010 | 2015-02-18 | Normal 180 Day Track |
| S009 | 2015-01-26 | Real-time Process |
| S008 | 2015-01-26 | Real-time Process |
| S007 | 2015-01-21 | 30-day Notice |
| S006 | 2015-01-21 | 30-day Notice |
| S005 | 2014-12-22 | 30-day Notice |
| S004 | 2014-12-15 | 30-day Notice |
| S003 | ||
| S002 | 2014-11-19 | 30-day Notice |
| S001 | 2014-09-18 | Normal 180 Day Track |