FoundationOne CDx (F1CDx)
FDA premarket approval P170019/S009 · decided 2019-08-21
Approval details
- PMA number
- P170019
- Supplement
- S009
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- FoundationOne CDx (F1CDx)
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Foundation Medicine, Inc.
- Date received
- 2019-07-23
- Decision date
- 2019-08-21
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Boston, MA
- Statement
- Approval for changing the reporting of some microsatellite stable results to Microsatellite Status-Cannot be Determined and to add a disclaimer in your report where you report microsatellite status and in the limitations section of the report indicating Patients with Microsatellite Status-Cannot be Determined should be retested with an orthogonal (alternative) method.
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