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 kras rgq pcr kit, which is to be used as a companion diagnostic for the drug vectibix (panitumumab). This device is indicated for:the therascreen kras rgq pcr kit is a real-time qualitative pcr assay used on the rotor-gene q mdx instrument for the detection of seven somatic mutations in the human kras oncogene, using dna extracted from formalin-fixed paraffin-embedded (ffpe), colorectal cancer (crc) tissue. The therascreen kras rgq pcr kit is intended to aid in the identification of crc patients for treatment with erbitux (cetuximab) and vectibix (panitumumab) based on a kras no mutation detected test result.
| Device | THERASCREEN KRAS RGQ PCR KIT |
| Classification Name | Somatic Gene Mutation Detection System |
| Generic Name | Somatic Gene Mutation Detection System |
| Applicant | QIAGEN MANCHESTER LTD |
| Date Received | 2011-07-25 |
| Decision Date | 2014-05-23 |
| Notice Date | 2014-06-10 |
| PMA | P110027 |
| Supplement | S |
| Product Code | OWD |
| Docket Number | 14M-0726 |
| Advisory Committee | Pathology |
| Expedited Review | No |
| 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 |
|---|---|---|
| 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 |