Guardant360 CDx

FDA Premarket Approval P200010 S002

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 of guardant360 cdx for expanding the indications for use to include the companion diagnostic claim to identify non-small cell lung cancer patients with kras g12c mutation for treatment with lumakrastm (sotorasib).

DeviceGuardant360 CDx
Generic NameNext Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
ApplicantGuardant Health, Inc.
Date Received2020-12-18
Decision Date2021-05-28
PMAP200010
SupplementS002
Product CodePQP 
Advisory CommitteePathology
Supplement TypePanel Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address Guardant Health, Inc. 505 Penobscot Drive redwood City, CA 94063

Supplemental Filings

Supplement NumberDateSupplement Type
P200010Original Filing
S002 2020-12-18 Panel Track
S001 2020-11-20 Panel Track

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