Premarket Approval (PMA)

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.

• Device: Oncomine™ Dx Express Test
• Generic Name: Next generation sequencing oncology panel, somatic or germline variant detection system
• Applicant: Life Technologies Corporation; 7335 Executive Way; Frederick, MD 21704
• PMA Number: P240040
• Supplement Number: S001
• Date Received: 07/11/2025
• Decision Date: 08/07/2025
• Product Code: PQP
• Advisory Committee: Pathology
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
approval for manufacturing process improvements