PMA P200010S022

Device: Guardant360 CDx
Applicant: Guardant Health, Inc.
Product code: PQP
Decision date: 2025-02-07
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Approval order statement: Approval to update the Guardant360 CDx (P200010) workflow to allow patient samples with cell free DNA (cfDNA) input less than 5ng to be processed by the Guardant360 CDx workflow and be evaluated based on post-sequencing quality control metric.

Current openFDA PMA Record

Device: Guardant360 CDx
Applicant: Guardant Health, Inc.
PMA number: P200010
Supplement: S022
Product code: PQP
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Decision date: 2025-02-07
Decision code: APPR
Date received: 2024-11-12
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval to update the Guardant360 CDx (P200010) workflow to allow patient samples with cell free DNA (cfDNA) input less than 5ng to be processed by the Guardant360 CDx workflow and be evaluated based on post-sequencing quality control metric.