QSE

Alzheimer’S Disease Pathology Assessment Test

Product code

QSE

Device name

Alzheimer’S Disease Pathology Assessment Test

Device class

Class 2

21 CFR

21 CFR 866.5840

Medical specialty

Immunology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

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

FDA classification definition

In vitro test to determine whether a patient presenting with cognitive impairment and being evaluated for AD and other causes of cognitive decline will test positive or negative for amyloid plaques or neurofibrillary tangles as measured by PET imaging agents.

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