Elecsys Phospho-Tau (217P) Plasma— 510(k) K261686

Name: FDA 510(k) clearance K261686
Creator: U.S. Food and Drug Administration
Published: 2026-08-19

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K261686 for Elecsys Phospho-Tau (217P) Plasma, Substantially Equivalent on 2026-08-19. Applicant: Roche Diagnostics. Device class: 2.

Clearance details

Applicant: Roche Diagnostics
Product code: Code SET
Device class: Class 2
Regulation: 21 CFR 866.5840
Advisory panel: Immunology
Date received: 2026-05-21
Decision date: 2026-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code SET

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K253240 — PrecivityAD2 Test2026-08-19
K252163 — Elecsys Phospho-Tau (181P) Plasma2025-10-08
K242706 — Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio2025-05-16

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K260049 — Elecsys Anti-HBc IgM2026-04-07

Data sourced from openFDA. This site is unofficial and independent of the FDA.