SET
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Immunoassay Blood Test For Amyloid Pathology Assessment
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5840
- Medical specialty
- Immunology
- FDA definition
- 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Elecsys Phospho-Tau (181P) Plasma (K252163) | Roche Diagnostics | 2025-10-08 |
| Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio (K242706) | Fujirebio Diagnostics,Inc. | 2025-05-16 |
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Every clearance here is in the API, with alerts when new ones post.