PMA P170019S009
- Device
- FoundationOne CDx (F1CDx)
- Applicant
- Foundation Medicine, Inc.
- PMA number
- P170019
- Supplement
- S009
- Product code
- PQP
- Decision date
- 2019-08-21
- Classification
- Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Approval order 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.
Current openFDA PMA Record#
- Device
- FoundationOne CDx (F1CDx)
- Applicant
- Foundation Medicine, Inc.
- PMA number
- P170019
- Supplement
- S009
- Product code
- PQP
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Decision date
- 2019-08-21
- Decision code
- APPR
- Date received
- 2019-07-23
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order 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.