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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: K252323 (cobas pulse blood glucose monitoring system), K252431 (Elecsys Calcitonin), K252280 (Elecsys Anti-SARS-CoV-2 S), K260046 (Elecsys Anti-HBc II).

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