myChoice HRD CDx

FDA Premarket Approval P190014 S005

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 an update to the contamination detection algorithm which is a quality control change to the mychoice cdx device software.

DevicemyChoice HRD CDx
Generic NameCancer-related Germline Gene Mutation Detection System
ApplicantMyriad Genetic Laboratories, Inc
Date Received2021-05-28
Decision Date2021-06-24
PMAP190014
SupplementS005
Product CodePJG 
Advisory CommitteePathology
Supplement TypeSpecial (immediate Track)
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Myriad Genetic Laboratories, Inc 320 Wankara Way salt Lake City, UT 84108

Supplemental Filings

Supplement NumberDateSupplement Type
P190014Original Filing
S005 2021-05-28 Special (immediate Track)
S004 2020-07-28 Normal 180 Day Track
S003 2020-02-11 Normal 180 Day Track
S002 2020-02-05 Real-time Process
S001 2020-01-23 Normal 180 Day Track

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.