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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 NumberS036
Date Received03/29/2022
Decision Date08/11/2022
Product Code PQP 
Advisory Committee Pathology
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to reduce the number of replicates assessed for quality control (QC) release testing.
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