SET

Immunoassay Blood Test For Amyloid Pathology Assessment

Product code

SET

Device name

Immunoassay Blood Test For Amyloid Pathology Assessment

Device class

Class 2

21 CFR

21 CFR 866.5840

Medical specialty

Immunology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

4

Summaries archived here

4 (direct download)

510(k) clearances (all years, FDA)

4 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (4)

Last three years. Most recent: 2026-08-19.

4 summaries are archived here for direct download.