BRACANALYSIS CDX

Cancer-related Germline Gene Mutation Detection System

FDA Premarket Approval P140020 S003

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.

Pre-market Approval Supplement Details

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.

DeviceBRACANALYSIS CDX
Classification NameCancer-related Germline Gene Mutation Detection System
Generic NameCancer-related Germline Gene Mutation Detection System
ApplicantMYRIAD GENETIC LABORATORIES
Date Received2015-09-17
Decision Date2015-11-18
PMAP140020
SupplementS003
Product CodePJG
Advisory CommitteePathology
Supplement TypeReal-time Process
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address MYRIAD GENETIC LABORATORIES 320 Wakara Way salt Lake City, UT 84108

Supplemental Filings

Supplement NumberDateSupplement Type
P140020Original Filing
S026 2023-01-11 30-day Notice
S025 2022-10-18 Special (immediate Track)
S024 2022-10-14 30-day Notice
S023
S022 2021-10-22 Normal 180 Day Track
S021 2021-06-04 30-day Notice
S020 2019-12-06 Normal 180 Day Track
S019 2019-07-02 Normal 180 Day Track
S018 2018-09-21 Normal 180 Day Track
S017 2018-07-31 Real-time Process
S016 2018-06-29 Normal 180 Day Track
S015 2018-04-09 Normal 180 Day Track
S014 2018-03-22 Normal 180 Day Track
S013 2017-09-29 30-day Notice
S012 2017-08-31 Normal 180 Day Track
S011
S010
S009 2016-12-20 Normal 180 Day Track
S008 2016-10-27 Normal 180 Day Track
S007 2016-06-07 Real-time Process
S006 2016-03-23 Real-time Process
S005 2015-01-21 30-day Notice
S004 2015-11-25 30-day Notice
S003 2015-09-17 Real-time Process
S002 2015-07-22 Real-time Process
S001 2015-06-19 Real-time Process

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