SET · Immunoassay Blood Test For Amyloid Pathology Assessment
Immunology · 21 CFR 866.5840 · Class 2
Overview
| Product Code | SET |
|---|---|
| Device Name | Immunoassay Blood Test For Amyloid Pathology Assessment |
| Regulation | 21 CFR 866.5840 |
| Device Class | Class 2 |
| Review Panel | Immunology |
Identification
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.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252163 | Elecsys Phospho-Tau (181P) Plasma | Roche Diagnostics | Oct 8, 2025 | SESE |
| K242706 | Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio | Fujirebio Diagnostics,Inc. | May 16, 2025 | SESE |
Top Applicants
- Fujirebio Diagnostics,Inc. — 1 clearance
- Roche Diagnostics — 1 clearance
