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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.
 
DeviceGuardant360® CDx
Generic NameNext generation sequencing oncology panel, somatic or germline variant detection system
ApplicantGuardant Health, Inc.
505 Penobscot Dr.
Redwood City, CA 94063
PMA NumberP200010
Supplement NumberS032
Date Received07/10/2026
Decision Date08/07/2026
Product Code PQP 
Advisory Committee Pathology
Clinical TrialsNCT04886804
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the clinical protocol titled “Clinical Validation of Guardant360 CDx for the Selection of First-Line Non-Small Cell Lung Cancer (NSCLC) Patients with ERBB2/HER2 TKD-Activating Mutations for Zongertinib Therapy” (Protocol No. 01-LU-038, PLP-003941 R1, Version 1.0) for the post-approval study.
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