Cleared Traditional

Lumipulse G pTau217/?-Amyloid 1-42 Plasma Ratio

K242706 · Fujirebio Diagnostics,Inc. · Immunology
May 2025
Decision
249d
Days
Class 2
Risk

About This 510(k) Submission

K242706 is an FDA 510(k) clearance for the Lumipulse G pTau217/?-Amyloid 1-42 Plasma Ratio, a Immunoassay Blood Test For Amyloid Pathology Assessment (Class II — Special Controls, product code SET), submitted by Fujirebio Diagnostics,Inc. (Malvern, US). The FDA issued a Cleared decision on May 16, 2025, 249 days after receiving the submission on September 9, 2024. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5840.

Submission Details

510(k) Number K242706 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 2024
Decision Date May 16, 2025
Days to Decision 249 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.