PMA P200010S032

Device: Guardant360® CDx
Applicant: Guardant Health, Inc.
PMA number: P200010
Supplement: S032
Product code: PQP
Decision date: 2026-08-07
Classification: Pathology
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
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.

Current openFDA PMA Record#

Device: Guardant360® CDx
Applicant: Guardant Health, Inc.
PMA number: P200010
Supplement: S032
Product code: PQP
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Decision date: 2026-08-07
Decision code: APPR
Date received: 2026-07-10
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
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.