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 bracanalysis cdx. This device is indicated as follows: bracanalysis cdx is an in vitro diagnostic device intended for the qualitative detection and classification of variants in the protein coding regions and intron/exon boundaries of the brca1 and brca2 genes using genomic dna obtained from whole blood specimens collected in edta. Single nucleotide variants and small insertions and deletions (indels) are identified by polymerase chain reaction (pcr) and sanger sequencing. Large deletions and duplications in brca1 and brca2 are detected using multiplex pcr. Results of the test are used as an aid in identifying ovarian cancer patients with deleterious or suspected deleterious germline brca variants eligible for treatment with lynparza (olaparib). This assay is for professional use only and is to be performed only at myriad genetic laboratories, a single laboratory site located at 320 wakara way, salt lake city, ut 84108.
| Device | BRACANALYSIS CDX |
| Classification Name | Cancer-related Germline Gene Mutation Detection System |
| Generic Name | Cancer-related Germline Gene Mutation Detection System |
| Applicant | MYRIAD GENETIC LABORATORIES |
| Date Received | 2014-09-24 |
| Decision Date | 2014-12-19 |
| Notice Date | 2014-12-30 |
| PMA | P140020 |
| Supplement | S |
| Product Code | PJG |
| Docket Number | 14M-2248 |
| Advisory Committee | Pathology |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | MYRIAD GENETIC LABORATORIES 320 Wakara Way salt Lake City, UT 84108 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P140020 | Original Filing | |
| S026 | 2023-01-11 | 30-day Notice |
| S025 | 2022-10-18 | Special (immediate Track) |
| S024 | 2022-10-14 | 30-day Notice |
| S023 | ||
| S022 | 2021-10-22 | Normal 180 Day Track |
| S021 | 2021-06-04 | 30-day Notice |
| S020 | 2019-12-06 | Normal 180 Day Track |
| S019 | 2019-07-02 | Normal 180 Day Track |
| S018 | 2018-09-21 | Normal 180 Day Track |
| S017 | 2018-07-31 | Real-time Process |
| S016 | 2018-06-29 | Normal 180 Day Track |
| S015 | 2018-04-09 | Normal 180 Day Track |
| S014 | 2018-03-22 | Normal 180 Day Track |
| S013 | 2017-09-29 | 30-day Notice |
| S012 | 2017-08-31 | Normal 180 Day Track |
| S011 | ||
| S010 | ||
| S009 | 2016-12-20 | Normal 180 Day Track |
| S008 | 2016-10-27 | Normal 180 Day Track |
| S007 | 2016-06-07 | Real-time Process |
| S006 | 2016-03-23 | Real-time Process |
| S005 | 2015-01-21 | 30-day Notice |
| S004 | 2015-11-25 | 30-day Notice |
| S003 | 2015-09-17 | Real-time Process |
| S002 | 2015-07-22 | Real-time Process |
| S001 | 2015-06-19 | Real-time Process |