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 therascreen® egfr rgq pcr kit. This device is indicated for: the therascreen® egfr rgq pcr kit is a real-time pcr test for the qualitative detection of exon 19 deletions and exon 21 (l858r) substitution mutations of the epidermal growth factor receptor (egfr) gene in dna derived from formalin-fixed paraffin-embedded (ffpe) nonsmall cell lung cancer (nsclc) tumor tissue. The test is intended to be used to select patients with nsclc for whom gilotrjf (afatinib), an egfr tyrosine kinase inhibitor (tki), is indicated. Safety and efficacy of gilotrif (afatinib) have not been established in patients whose tumors have l861q, g719x, 87681, exon 20 insertions, and t790m mutations, which are also detected by the therascreen® egfr rgq pcr kit. Specimens are processed using the qiaamp® dsp dna ffpe tissue kit for manual sample preparation and the rotor-gene® q mdx instrument for automated amplification anddetection.
| 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 | 2012-11-30 |
| Decision Date | 2013-07-12 |
| Notice Date | 2013-07-15 |
| PMA | P120022 |
| Supplement | S |
| Product Code | OWD |
| Docket Number | 13M-0851 |
| Advisory Committee | Pathology |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | QIAGEN MANCHESTER LTD skelton House lloyd Street North manchester M15 6 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| 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 |