Approval of the clinical protocol titled “oncomine dx target test clinical validation protocol: biomarker egfr exon 20 insertions (olympic) - prj0002127 supplemental sample study ”, for the post-approval study (pas) referenced above. The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for p160045/s027
| Device | Oncomine Dx Target Test |
| Generic Name | Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System |
| Applicant | LIFE TECHNOLOGIES CORPORATION |
| Date Received | 2021-12-23 |
| Decision Date | 2022-01-21 |
| PMA | P160045 |
| Supplement | S034 |
| Product Code | PQP |
| Advisory Committee | Pathology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | LIFE TECHNOLOGIES CORPORATION 5781 Van Allen Way carlsbad, CA 92008 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P160045 | | Original Filing |
| S038 |
2022-08-05 |
Normal 180 Day Track No User Fee |
| S037 |
2022-06-14 |
Real-time Process |
| S036 |
2022-03-29 |
135 Review Track For 30-day Notice |
| S035 |
2022-03-08 |
Panel Track |
| S034 |
2021-12-23 |
Normal 180 Day Track No User Fee |
| S033 | | |
| S032 | | |
| S031 | | |
| S030 |
2021-05-14 |
30-day Notice |
| S029 | | |
| S028 | | |
| S027 | | |
| S026 | | |
| S025 | | |
| S024 |
2020-11-06 |
30-day Notice |
| S023 |
2020-10-01 |
30-day Notice |
| S022 |
2020-09-11 |
30-day Notice |
| S021 | | |
| S020 |
2020-05-14 |
30-day Notice |
| S019 | | |
| S018 |
2019-10-16 |
30-day Notice |
| S017 | | |
| S016 |
2019-07-22 |
30-day Notice |
| S015 |
2019-04-23 |
30-day Notice |
| S014 |
2019-01-31 |
30-day Notice |
| S013 |
2019-01-25 |
30-day Notice |
| S012 |
2018-11-13 |
30-day Notice |
| S011 |
2018-10-19 |
30-day Notice |
| S010 |
2018-10-09 |
30-day Notice |
| S009 | | |
| S008 |
2018-07-20 |
30-day Notice |
| S007 | | |
| S006 |
2018-05-02 |
30-day Notice |
| S005 |
2018-03-22 |
Normal 180 Day Track No User Fee |
| S004 | | |
| S003 |
2017-11-20 |
30-day Notice |
| S002 |
2017-11-08 |
30-day Notice |
| S001 |
2017-07-28 |
30-day Notice |
NIH GUDID Devices