QSE · AlzheimerS Disease Pathology Assessment Test
Immunology · 21 CFR 866.5840 · Class 2
Overview
| Product Code | QSE |
|---|---|
| Device Name | AlzheimerS Disease Pathology Assessment Test |
| Regulation | 21 CFR 866.5840 |
| Device Class | Class 2 |
| Review Panel | Immunology |
Identification
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.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K231348 | Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF | Roche Diagnostics | Jun 5, 2023 | SESE |
| K221842 | Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF | Roche Diagnostics | Dec 7, 2022 | SESE |
| DEN200072 | Lumipulse G ß-Amyloid Ratio (1-42/1-40) | Fujirebio Diagnostics,Inc. | May 4, 2022 | DENG |
Top Applicants
- Roche Diagnostics — 2 clearances
- Fujirebio Diagnostics,Inc. — 1 clearance
