FDA product code QSE: AlzheimerS Disease Pathology Assessment Test
QSE is the FDA product code for alzheimers disease pathology assessment test. It is a Class II device, regulated under 21 CFR 866.5840 and reviewed by the Immunology panel. FDA has cleared 2 510(k) submissions under QSE, 2 in the last five years. The average 510(k) review took 96 days (median 96). 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | AlzheimerS Disease Pathology Assessment Test |
| Device class | Class II |
| Regulation | 21 CFR 866.5840 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
510(k) clearances per year for QSE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 166 |
| 2023 | 1 | 27 |
Compare with all 510(k) review times · Search every QSE clearance
Top QSE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Roche Diagnostics | 2 | 2023-06-05 |
Most recent QSE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K231348 | Roche Diagnostics | Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF | 2023-06-05 | 27 |
| K221842 | Roche Diagnostics | Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF | 2022-12-07 | 166 |
Recalls for QSE devices
openFDA lists no recalls for product code QSE.
Frequently asked questions
What is FDA product code QSE?
QSE is the FDA product code for alzheimers disease pathology assessment test. It is a Class II device, regulated under 21 CFR 866.5840 and reviewed by the Immunology panel.
What device class is QSE?
Class II, regulation 21 CFR 866.5840. Typical premarket route: 510(k).
How long does a 510(k) take for product code QSE?
Across 2 cleared submissions the average was 96 days from receipt to decision (median 96).
Which companies have the most QSE clearances?
Roche Diagnostics (2).
Next steps
- Run an FDA pathway report with predicate devices for product code QSE
- Run a recall and safety report across every QSE manufacturer
- Watch product code QSE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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