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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 NumberS031
Date Received09/24/2021
Decision Date09/21/2022
Product Code PQP 
Docket Number 22M-2339
Notice Date 10/14/2022
Advisory Committee Pathology
Clinical TrialsNCT03157128
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 the identification of RET fusions in NSCLC patients, RET mutations in medullary thyroid cancer (MTC) patients and RET fusions in thyroid cancer (TC) patients who may benefit from RETEVMO® (selpercatinib).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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