Device class
Class II
Regulation 866.5840
Total clearances
4
2025-05-16 → 2026-08-19
Definition
What is Immunoassay Blood Test For Amyloid Pathology Assessment
An Immunoassay blood test for amyloid pathology assessment is an in vitro diagnostic test used to identify patients with amyloid pathology associated with Alzheimers 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.
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 |
| 81599 |
CPT
|
— |
Medium
|
Unlisted molecular pathology procedure; amyloid biomarker assessment |
| 86704 |
CPT
|
— |
Medium
|
Immunoassay for amyloid-related proteins in serum |
Pulse
Most recent 510(k) clearances