This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for clarifications to the intended use statement, 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, who are or may become 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 in salt lake city, utah.
| 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 | 2015-09-17 |
| Decision Date | 2015-11-18 |
| PMA | P140020 |
| Supplement | S003 |
| Product Code | PJG |
| Advisory Committee | Pathology |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MYRIAD GENETIC LABORATORIES 320 Wakara Way salt Lake City, UT 84108 |
| 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 |