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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namecancer-related germline gene mutation detection system
Generic Namecancer-related germline gene mutation detection system
320 wakara way
salt lake city, UT 84108
PMA NumberP140020
Date Received09/24/2014
Decision Date12/19/2014
Product Code
PJG[ Registered Establishments with PJG ]
Docket Number 14M-2248
Notice Date 12/30/2014
Advisory Committee Pathology
Clinical Trials NCT00753545
Expedited Review Granted? Yes
Combination Product No
Approval Order 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.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S007