FDA product code SET: Immunoassay Blood Test For Amyloid Pathology Assessment
SET is the FDA product code for immunoassay blood test for amyloid pathology assessment. It is a Class II device, regulated under 21 CFR 866.5840 and reviewed by the Immunology panel. FDA has cleared 4 510(k) submissions under SET, 4 in the last five years, from 3 different applicants. The average 510(k) review took 188 days (median 170); 188 days on average over the last three years. FDA has posted 7 recalls for SET devices, 7 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Immunoassay Blood Test For Amyloid Pathology Assessment |
| 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 SET
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 2 | 170 |
| 2026 | 2 | 207 |
Compare with all 510(k) review times · Search every SET clearance
Top SET applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Roche Diagnostics | 2 | 2026-08-19 |
| C2N Diagnostics, LLC | 1 | 2026-08-19 |
| Fujirebio Diagnostics,Inc. | 1 | 2025-05-16 |
Most recent SET clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253240 | C2N Diagnostics, LLC | PrecivityAD2 Test | 2026-08-19 | 324 |
| K261686 | Roche Diagnostics | Elecsys Phospho-Tau (217P) Plasma | 2026-08-19 | 90 |
| K252163 | Roche Diagnostics | Elecsys Phospho-Tau (181P) Plasma | 2025-10-08 | 90 |
| K242706 | Fujirebio Diagnostics,Inc. | Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio | 2025-05-16 | 249 |
Recalls for SET devices
7 product recalls in 1 recall events; 7 initiated in the last five years and 7 still open. Most recent: 2025-12-11.
| Year | Recalls |
|---|---|
| 2025 | 7 |
Frequently asked questions
What is FDA product code SET?
SET is the FDA product code for immunoassay blood test for amyloid pathology assessment. It is a Class II device, regulated under 21 CFR 866.5840 and reviewed by the Immunology panel.
What device class is SET?
Class II, regulation 21 CFR 866.5840. Typical premarket route: 510(k).
How long does a 510(k) take for product code SET?
Across 4 cleared submissions the average was 188 days from receipt to decision (median 170).
Which companies have the most SET clearances?
Roche Diagnostics (2); C2N Diagnostics, LLC (1); Fujirebio Diagnostics,Inc. (1).
Have SET devices been recalled?
Yes: 7 product recalls across 1 recall events; the most recent began 2025-12-11.
Next steps
- Run an FDA pathway report with predicate devices for product code SET
- Run a recall and safety report across every SET manufacturer
- Watch product code SET 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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