FoundationOne CDx (F1CDx)

FDA Premarket Approval P170019 S023

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

Expanding the indications for use to include a cdx indication for detecting alk rearrangements in non-small cell lung cancer patients who may be candidates for brigatinib treatment.

DeviceFoundationOne CDx (F1CDx)
Generic NameNext Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
ApplicantFoundation Medicine, Inc.
Date Received2020-12-01
Decision Date2021-06-30
PMAP170019
SupplementS023
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
S026 2020-12-28 Normal 180 Day Track
S025
S024
S023 2020-12-01 Normal 180 Day Track
S022
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
S017
S016
S015 2019-12-16 Panel Track
S014
S013 2019-10-31 Panel Track
S012 2019-10-21 Special (immediate Track)
S011
S010
S009 2019-07-23 Special (immediate Track)
S008 2019-04-09 Normal 180 Day Track
S007
S006
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
S001

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