WHERE ARE YOU?

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

THE TAPE

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 / August 2026 / K261686

510(k) cleared

Elecsys Phospho-Tau (217P) Plasma

Roche Diagnostics · Aug 19, 2026 · K261686

FDA cleared the Elecsys Phospho-Tau (217P) Plasma from Roche Diagnostics on Aug 19, 2026 under K261686, a traditional 510(k). The device falls under product code SET, Immunoassay Blood Test For Amyloid Pathology Assessment, regulated at 21 CFR 866.5840 as a Class 2 device. The review panel was Immunology.

FDA logged the submission as received on May 21, 2026. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

Roche Diagnostics has 8 other decisions in the tracker over the last 12 months: K260221 (Elecsys EBV EBNA IgG), K260232 (Elecsys EBV VCA IgG), K260233 (Elecsys EBV IgM), K252323 (cobas pulse blood glucose monitoring system).

Questions & Answers

What did FDA clear under K261686?

K261686 is the FDA 510(k) for Elecsys Phospho-Tau (217P) Plasma, submitted by Roche Diagnostics. FDA's decision date was Aug 19, 2026, under product code SET (Immunoassay Blood Test For Amyloid Pathology Assessment).

Who makes the Elecsys Phospho-Tau (217P) Plasma?

Roche Diagnostics, based in Indianapolis, IN, is the applicant of record for K261686.

How long did the K261686 review take?

FDA received the submission on May 21, 2026 and issued its decision on Aug 19, 2026, 90 days later.

← All decisions in August 2026