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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.
DeviceOncomine™ Dx Target Test
Generic NameNext generation sequencing oncology panel, somatic or germline variant detection system
PMA NumberP160045
Supplement NumberS028
Date Received03/02/2021
Decision Date08/25/2021
Product Code PQP 
Docket Number 21M-0962
Notice Date 09/23/2021
Advisory Committee Pathology
Clinical TrialsNCT02989857
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval to expand the intended use of the Oncomine Dx Target Test to include a companion diagnostic indication for the detection of single nucleotide variants in IDH1 in cholangiocarcinoma patients who may benefit from treatment with TIBSOVO (ivosidenib).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness