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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
ApplicantLife Technologies Corporation
5781 Van Allen Way
Carlsbad, CA 92008
PMA NumberP160045
Supplement NumberS038
Date Received08/05/2022
Decision Date02/01/2023
Product Code PQP 
Advisory Committee Pathology
Clinical TrialsNCT02609776
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to update the user guide for the Oncomine Dx Target Test to include the results of the supplemental clinical data submitted in the Post-Approval Study (PAS) Protocol.
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