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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 NumberS046
Date Received02/28/2024
Decision Date10/17/2024
Product Code PQP 
Docket Number 24M-4888
Notice Date 10/25/2024
Advisory Committee Pathology
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to expand the intended use of the Oncomine DxTM Target Test to include a companion diagnostic indication for the detection of IDH1 and IDH2 single nucleotide variants (SNVs) in astrocytoma (AC) and oligodendroglioma (OG) patients who may benefit from treatment with VORANIGO® (vorasidenib).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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