Cancer-Related Germline Gene Mutation Detection System
Basic Information
- Device Name
- Cancer-Related Germline Gene Mutation Detection System
- Trade Name
- BRACANALYSIS CDX
- PMA Number
- P140020
- Device Class
- FDA Class 3
- Product Code
- PJG
- Generic Name
- Cancer-related germline gene mutation detection system
- Medical Specialty
- Unknown
- Advisory Committee
- Pathology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- December 19, 2014
- Date Received
- September 24, 2014
- Expedited Review
- Y
- Docket Number
- 14M-2248
Advisory Committee 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 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PJG | Cancer-Related Germline Gene Mutation Detection System | FDA class 3 | Unknown |