FDA.reportPublic FDA data

PMA P170019S026

Device
FoundationOne CDx (F1CDx)
Applicant
Foundation Medicine, Inc.
PMA number
P170019
Supplement
S026
Product code
PQP
Decision date
2021-07-30
Generic name
Next generation sequencing oncology panel, somatic or germline variant detection system
Approval order statement
Approval for a new fractional-based (FB) microsatellite instability (MSI) classification algorithm to replace the principal component analysis (PCA)- based MSI algorithm within F1CDxs tumor profiling indication.

Current openFDA PMA Record#

Device
FoundationOne CDx (F1CDx)
Applicant
Foundation Medicine, Inc.
PMA number
P170019
Supplement
S026
Product code
PQP
Generic name
Next generation sequencing oncology panel, somatic or germline variant detection system
Decision date
2021-07-30
Decision code
APPR
Date received
2020-12-28
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a new fractional-based (FB) microsatellite instability (MSI) classification algorithm to replace the principal component analysis (PCA)- based MSI algorithm within F1CDxs tumor profiling indication.