FoundationOne CDx (F1CDx)
FDA premarket approval P170019/S036 · decided 2023-09-18
Approval details
- PMA number
- P170019
- Supplement
- S036
- Supplement type
- Normal 180 Day 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
- 2022-08-01
- Decision date
- 2023-09-18
- Days to decision
- 413 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Boston, MA
- Statement
- Approval for a DNA/RNA CoExtraction (CoEx) method, and removal of reporting of copy number alterations (amplifications and deletions/losses) for the tumor profiling indication from the intended use/indications for use when using the DNA/RNA CoEx method.
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