DeviceClearance

Product code SET— Immunology

Elecsys Phospho-Tau (181P) Plasma

Classification name
Immunoassay Blood Test For Amyloid Pathology Assessment
Device class
Class 2
Regulation
21 CFR 866.5840
Advisory panel
Immunology
Total cleared
4
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code SET under 21 CFR 866.5840, via openFDA

Market context for product code SET

FDA has cleared 4 devices under product code SET between 2025 and 2026, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code SET

Recent clearances under product code SET

Data sourced from openFDA. This site is unofficial and independent of the FDA.