FoundationOne CDx (F1CDx)
FDA premarket approval P170019/S051 · decided 2024-01-12
Approval details
- PMA number
- P170019
- Supplement
- S051
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FoundationOne CDx (F1CDx)
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Foundation Medicine, Inc.
- Date received
- 2023-12-15
- Decision date
- 2024-01-12
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Boston, MA
- Statement
- Approval for the removal of the four variants, namely CDK12 (splice site 1047-2A>G), BRCA1 (splice site 594-2A>C), RAD54L (C391fs*1) and BRCA1 (R170Q), which are now considered as benign variants based on the evidence that the sponsor provided, from the FDA-approved CDx claims.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.