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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids
510(k) Number K260827
Device Name Oncomine ™ Dx Express Test
Applicant
Life Technologies Corporation
7335 Executive Way
Frederick,  MD  21704
Applicant Contact Ángel Casanova-Torres
Correspondent
Life Technologies Corporation
7335 Executive Way
Frederick,  MD  21704
Correspondent Contact Ángel Casanova-Torres
Classification Product Code
SBY  
Date Received03/13/2026
Decision Date 10/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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