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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: 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.
 
DeviceBRACANALYSIS CDX
Generic NameCancer-related germline gene mutation detection system
ApplicantMYRIAD GENETIC LABORATORIES
320 Wakara Way
Salt Lake City, UT 84108
PMA NumberP140020
Supplement NumberS003
Date Received09/17/2015
Decision Date11/18/2015
Product Code PJG 
Advisory Committee Pathology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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.
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