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.

Summary

Roche Diagnostics filed Elecsys Phospho-Tau (217P) Plasma under product code SET, immunoassay blood tests for amyloid pathology assessment. The record gives no further description.

Class II, 21 CFR 866.5840. Immunology is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Roche filed from Indianapolis, Indiana. The substantially equivalent decision came 90 calendar days after receipt (May 21 to August 19, 2026).

Clearance details

Applicant: Roche Diagnostics
Product code: Product 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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Data sourced from openFDA. This site is unofficial and independent of the FDA.