FoundationOne CDx (F1CDx)

FDA Premarket Approval P170019 S021

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.

Pre-market Approval Supplement Details

Approval to expand the intended use of foundationone cdx (f1cdx) to include a companion diagnostic indication for fgfr2 fusion/rearrangements in patients with cholangiocarcinoma who may benefit from treatment with truseltiq™ (infigratinib).

DeviceFoundationOne CDx (F1CDx)
Generic NameNext Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
ApplicantFoundation Medicine, Inc.
Date Received2020-10-29
Decision Date2021-05-28
Product CodePQP 
Advisory CommitteePathology
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address Foundation Medicine, Inc. 150 Second Street, 1st Floor cambridge, MA 02141

Supplemental Filings

Supplement NumberDateSupplement Type
P170019Original Filing
S021 2020-10-29 Normal 180 Day Track
S020 2020-07-20 Real-time Process
S019 2020-04-27 Real-time Process
S018 2020-04-16 30-day Notice
S015 2019-12-16 Panel Track
S013 2019-10-31 Panel Track
S012 2019-10-21 Special (immediate Track)
S009 2019-07-23 Special (immediate Track)
S008 2019-04-09 Normal 180 Day Track
S005 2018-10-12 Normal 180 Day Track
S004 2018-09-24 Normal 180 Day Track
S003 2018-08-30 Real-time Process
S002 2018-08-24 Real-time Process

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