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
- Supplement Number
- S003
- 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
- November 18, 2015
- Date Received
- September 17, 2015
- Supplement Type
- Real-Time Process
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
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.
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 |