Device class
Class II
Regulation 866.5840
Total clearances
3
2022-05-04 → 2023-06-05
Definition
What is AlzheimerS Disease Pathology Assessment Test
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.
Classification details
Medical specialty
Immunology
Regulation number
866.5840
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 78809 |
CPT
|
— |
Medium
|
Brain PET imaging; test measures amyloid/tau via PET agents |
| 96121 |
CPT
|
— |
Medium
|
Neuropsychological testing for cognitive decline; correlates with AD pathology assessment |
Pulse
Most recent 510(k) clearances