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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.
400 Summer St.
Boston, MA 02210
PMA NumberP170019
Supplement NumberS051
Date Received12/15/2023
Decision Date01/12/2024
Product Code PQP 
Advisory Committee Pathology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the removal of the four variants, namely CDK12 (splice site 1047-2A>G), BRCA1 (splice site 594-2A>C), RAD54L (C391fs*1) and BRCA1 (R170Q), which are now considered as benign variants based on the evidence that the sponsor provided, from the FDA-approved CDx claims.
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