FoundationOne CDx Assay
FDA premarket approval P170019/S005 · decided 2019-04-10
Approval details
- PMA number
- P170019
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FoundationOne CDx Assay
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Foundation Medicine, Inc.
- Date received
- 2018-10-12
- Decision date
- 2019-04-10
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Boston, MA
- Statement
- Approval for FoundationOne CDx (F1CDx) for reporting of homologous recombination deficiency (HRD) status in ovarian cancer patients.
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