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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 NumberS042
Date Received04/03/2023
Decision Date08/17/2023
Product Code PQP 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval to include limitation in labelling. The updated labeling to include the statement: "Interference in variant calling can be observed at higher concentrations of chenodeoxycholic acid in cholangiocarcinoma (CC) clinical FFPE samples with IDH1 variants present at an allelic frequency near the limit of detection (LoD)."
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