PMA P140020S003
- Device
- BRACANALYSIS CDX
- Applicant
- Myriad Genetic Laboratories
- PMA number
- P140020
- Supplement
- S003
- Product code
- PJG
- Decision date
- 2015-11-18
- Classification
- Cancer-related Germline Gene Mutation Detection System
- Generic name
- Cancer-related germline gene mutation detection system
- Approval order 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.
Current openFDA PMA Record#
- Device
- BRACANALYSIS CDX
- Applicant
- Myriad Genetic Laboratories
- PMA number
- P140020
- Supplement
- S003
- Product code
- PJG
- Generic name
- Cancer-related germline gene mutation detection system
- Decision date
- 2015-11-18
- Decision code
- APPR
- Date received
- 2015-09-17
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order 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.