BRACANALYSIS CDX
FDA premarket approval P140020 · decided 2014-12-19
Approval details
- PMA number
- P140020
- Trade name
- BRACANALYSIS CDX
- Generic name
- Cancer-related germline gene mutation detection system
- Applicant
- Myriad Genetic Laboratories
- Date received
- 2014-09-24
- Decision date
- 2014-12-19
- Days to decision
- 86 days
- Decision code
- APPR
- Product code
- PJG
- Advisory committee
- Pathology
- Expedited review
- Yes
- Location
- Salt Lake Cit, UT
- Statement
- 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
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