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SET — Immunoassay Blood Test For Amyloid Pathology Assessment Class II

FDA Device Classification

Classification Details

Product Code
SET
Device Class
Class II
Regulation Number
866.5840
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252163roche diagnosticsElecsys Phospho-Tau (181P) PlasmaOctober 8, 2025
K242706fujirebio diagnosticsLumipulse G pTau217/ß-Amyloid 1-42 Plasma RatioMay 16, 2025