FoundationOne CDx
FDA premarket approval P170019 · decided 2017-11-30
Approval details
- PMA number
- P170019
- Trade name
- FoundationOne CDx
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Foundation Medicine, Inc.
- Date received
- 2017-06-02
- Decision date
- 2017-11-30
- Days to decision
- 181 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- Yes
- Location
- Boston, MA
- Statement
- Approval for the FoundationOne CDx (F1CDx). This device is a next generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens. The test is intended as a c
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