DeviceClearance

Product code QSE— Immunology

Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF

Classification name
Alzheimer’S Disease Pathology Assessment Test
Device class
Class 2
Regulation
21 CFR 866.5840
Advisory panel
Immunology
Total cleared
3
First cleared
Most recent

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.”

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

Market context for product code QSE

FDA has cleared 3 devices under product code QSE between 2022 and 2023, filed by 2 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 QSE

Recent clearances under product code QSE

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