WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

FDA posts two worked PCCP examples for machine learning devices Haemonetics wins FDA approval for a patch that seals 26F arteriotomies FDA adds Olympus enteroscopes and capsule systems to Import Alert 89-04 Nova Biomedical pulls Gen 2.0 StatStrip glucose meters over stale barcode scans AdvaMed plans industry cybersecurity standards written like a code of ethics Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Paradromics hands Siemens Healthineers the imaging workup for its brain implant FDA posts two worked PCCP examples for machine learning devices Haemonetics wins FDA approval for a patch that seals 26F arteriotomies FDA adds Olympus enteroscopes and capsule systems to Import Alert 89-04 Nova Biomedical pulls Gen 2.0 StatStrip glucose meters over stale barcode scans AdvaMed plans industry cybersecurity standards written like a code of ethics Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Paradromics hands Siemens Healthineers the imaging workup for its brain implant

The Tracker / October 2026 / K260827

510(k) cleared

Oncomine Dx Express Test

Life Technologies Corporation · Oct 15, 2026 · K260827

FDA cleared the Oncomine Dx Express Test from Life Technologies Corporation on Oct 15, 2026 under K260827, a traditional 510(k). The device falls under product code SBY, High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids, regulated at 21 CFR 866.6085 as a Class 2 device. The review panel was Pathology.

FDA logged the submission as received on Mar 13, 2026. The decision came 216 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Life Technologies Corporation has one other decision in the tracker over the last 12 months: K252407 (OxyGo Portable Oxygen Concentrator (1400-7000)).

Questions & Answers

What did FDA clear under K260827?

K260827 is the FDA 510(k) for Oncomine Dx Express Test, submitted by Life Technologies Corporation. FDA's decision date was Oct 15, 2026, under product code SBY (High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids).

Who makes the Oncomine Dx Express Test?

Life Technologies Corporation, based in Frederick, MD, is the applicant of record for K260827.

How long did the K260827 review take?

FDA received the submission on Mar 13, 2026 and issued its decision on Oct 15, 2026, 216 days later.

← All decisions in October 2026

Sources