Cleared Traditional

Elecsys Phospho-Tau (181P) Plasma

K252163 · Roche Diagnostics · Immunology

Oct 2025

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K252163 is an FDA 510(k) clearance for the Elecsys Phospho-Tau (181P) Plasma, a Immunoassay Blood Test For Amyloid Pathology Assessment (Class II — Special Controls, product code SET), submitted by Roche Diagnostics (Indianpolis, US). The FDA issued a Cleared decision on October 8, 2025, 90 days after receiving the submission on July 10, 2025. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5840.

Submission Details

510(k) Number	K252163 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 10, 2025
Decision Date	October 08, 2025
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF

Device Classification

Product Code	SET — Immunoassay Blood Test For Amyloid Pathology Assessment
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.5840
Definition	An Immunoassay Blood Test For Amyloid Pathology Assessment Is An In Vitro Diagnostic Test Used To Identify Patients With Amyloid Pathology Associated With Alzheimer?s Disease Who Have Signs And Symptoms Of Cognitive Decline. The Results Of The Test Are To Be Interpreted In Conjunction With Other Patient Clinical Information.