QSE — AlzheimerS Disease Pathology Assessment Test Class II
FDA product code QSE covers "AlzheimerS Disease Pathology Assessment Test", a Class II medical device regulated under 21 CFR 866.5840. Submissions are reviewed by the Immunology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QSE
- Device Class
- Class II
- Regulation Number
- 866.5840
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Definition
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 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K231348 | roche diagnostics | Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF | June 5, 2023 |
| K221842 | roche diagnostics | Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF | December 7, 2022 |
| DEN200072 | fujirebio diagnostics | Lumipulse G ß-Amyloid Ratio (1-42/1-40) | May 4, 2022 |