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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 CDx (F1CDx)
Generic NameNext generation sequencing oncology panel, somatic or germline variant detection system
ApplicantFoundation Medicine, Inc.
150 Second St.
1st Floor
Cambridge, MA 02141
PMA NumberP170019
Supplement NumberS048
Date Received07/03/2023
Decision Date11/16/2023
Product Code PQP 
Docket Number 24M-0044
Notice Date 01/12/2024
Advisory Committee Pathology
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval order to expand the intended use of FoundationOne®CDx (F1CDx) to include a companion diagnostic (CDx) indication for the detection of PIK3CA/AKT1/PTEN-alterations in patients with breast cancer who may benefit from treatment with TRUQAP™(capivasertib) in combination with FASLODEX®(fulvestrant).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Labeling
Labeling Part 2
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