Approval for the praxis extended ras panel is a qualitative in vitro diagnostic test using targeted high throughput parallel sequencing for the detection of 56 specific mutations in ras genes [kras (exons 2, 3, and 4) and nras (exons 2, 3, and 4)] in dna extracted from formalin-fixed, paraffin-embedded (ffpe) colorectal cancer (crc) tissue samples. The praxis™ extended ras panel is indicated to aid in the identification of patients with colorectal cancer for treatment with vectibix® (panitumumab) based on a no mutation detected test result. The test is intended to be used on the illumina miseqdx® instrument.
| Device | Praxis Extended RAS Panel |
| Classification Name | Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System |
| Generic Name | Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System |
| Applicant | Illumina, Inc. |
| Date Received | 2016-09-02 |
| Decision Date | 2017-06-29 |
| Notice Date | 2017-06-30 |
| PMA | P160038 |
| Supplement | S |
| Product Code | PQP |
| Docket Number | 17M-3983 |
| Advisory Committee | Pathology |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | Illumina, Inc. 5200 Illumina Way san Diego, CA 92122 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P160038 | | Original Filing |
| S024 |
2022-12-22 |
30-day Notice |
| S023 |
2022-08-18 |
30-day Notice |
| S022 |
2022-06-13 |
30-day Notice |
| S021 |
2022-02-28 |
30-day Notice |
| S020 |
2021-04-12 |
30-day Notice |
| S019 | | |
| S018 |
2020-11-09 |
30-day Notice |
| S017 |
2020-08-04 |
30-day Notice |
| S016 |
2020-04-06 |
30-day Notice |
| S015 |
2020-01-16 |
30-day Notice |
| S014 |
2019-10-29 |
30-day Notice |
| S013 |
2019-07-31 |
30-day Notice |
| S012 |
2019-04-24 |
30-day Notice |
| S011 | | |
| S010 |
2019-03-06 |
30-day Notice |
| S009 |
2019-02-15 |
30-day Notice |
| S008 |
2019-02-15 |
30-day Notice |
| S007 |
2018-12-10 |
30-day Notice |
| S006 |
2018-08-24 |
30-day Notice |
| S005 |
2018-08-06 |
30-day Notice |
| S004 |
2018-06-01 |
30-day Notice |
| S003 |
2018-04-04 |
30-day Notice |
| S002 |
2018-03-05 |
Special (immediate Track) |
| S001 |
2018-03-01 |
30-day Notice |
NIH GUDID Devices