Guardant360 CDx
FDA premarket approval P200010/S022 · decided 2025-02-07
Approval details
- PMA number
- P200010
- Supplement
- S022
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Guardant360 CDx
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Guardant Health, Inc.
- Date received
- 2024-11-12
- Decision date
- 2025-02-07
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Redwood City, CA
- 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.
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