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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
DeviceFoundationOne Liquid CDx (F1LCDx)
Generic NameNext generation sequencing oncology panel, somatic or germline variant detection system
ApplicantFoundation Medicine Inc.
150 Second Street
Cambridge, MA 02141
PMA NumberP190032
Supplement NumberS004
Date Received04/13/2022
Decision Date12/22/2022
Product Code PQP 
Docket Number 23M-3457
Notice Date 08/18/2023
Advisory Committee Pathology
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval to include a companion diagnostic indication for NTRK1, NTRK2, and NTRK3 fusions in patients with solid tumors and for ROS1 fusions in patients with non-small cell lung cancer who may benefit from treatment with ROZLYTREK® (entrectinib).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness