Approval for the therascreen kras rgq pcr kit. This device is indicated for: the therascreen kras rgq pcr kit is a real-time qualitative pcr assay used on the rotorgene 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) based on a kras no mutation detected test result.
| Device | THERASCREEN KRAS RGQ PCR KIT |
| Generic Name | Somatic Gene Mutation Detection System |
| Applicant | QIAGEN MANCHESTER LTD |
| Date Received | 2011-07-28 |
| Decision Date | 2012-07-06 |
| Notice Date | 2012-07-16 |
| PMA | P110030 |
| Supplement | S |
| Product Code | OWD |
| Docket Number | 12M-0735 |
| Advisory Committee | Pathology |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | QIAGEN MANCHESTER LTD skeleton House, Lloyd Street North manchester |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P110030 | Original Filing |