FoundationOne Liquid CDx (F1LCDx)
FDA premarket approval P190032/S018 · decided 2024-02-08
Approval details
- PMA number
- P190032
- Supplement
- S018
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- FoundationOne Liquid CDx (F1LCDx)
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Foundation Medicine, Inc.
- Date received
- 2024-01-11
- Decision date
- 2024-02-08
- 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 two variants, namely BRCA1 (splice site 594-2A>C) and BRCA1 (R170Q), which are now considered as benign variants based on the evidence that the sponsor provided, from the FDA-approved CDx claims.
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