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Comments close on FDA's generative AI device framework 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 Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework 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 Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / October 2026 / K260233

510(k) cleared

Elecsys EBV IgM

Roche Diagnostics · Oct 2, 2026 · K260233

FDA cleared the Elecsys EBV IgM from Roche Diagnostics on Oct 2, 2026 under K260233, a traditional 510(k). The device falls under product code LJN, Antibody Igm, If, Epstein-Barr Virus, regulated at 21 CFR 866.3235 as a Class 1 device. The review panel was Microbiology.

FDA logged the submission as received on Jan 26, 2026. The decision came 249 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Roche Diagnostics has 8 other decisions in the tracker over the last 12 months: K260221 (Elecsys EBV EBNA IgG), K260232 (Elecsys EBV VCA IgG), K261686 (Elecsys Phospho-Tau (217P) Plasma), K252323 (cobas pulse blood glucose monitoring system).

Questions & Answers

What did FDA clear under K260233?

K260233 is the FDA 510(k) for Elecsys EBV IgM, submitted by Roche Diagnostics. FDA's decision date was Oct 2, 2026, under product code LJN (Antibody Igm, If, Epstein-Barr Virus).

Who makes the Elecsys EBV IgM?

Roche Diagnostics, based in Indianapolis, IN, is the applicant of record for K260233.

How long did the K260233 review take?

FDA received the submission on Jan 26, 2026 and issued its decision on Oct 2, 2026, 249 days later.

← All decisions in October 2026