Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5840](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5840) → SET — Immunoassay Blood Test For Amyloid Pathology Assessment

# SET · Immunoassay Blood Test For Amyloid Pathology Assessment

_Immunology · 21 CFR 866.5840 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/SET

## Overview

- **Product Code:** SET
- **Device Name:** Immunoassay Blood Test For Amyloid Pathology Assessment
- **Regulation:** [21 CFR 866.5840](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5840)
- **Device Class:** 2
- **Review Panel:** [Immunology](/submissions/IM)

## Identification

An Immunoassay blood test for amyloid pathology assessment is an in vitro diagnostic test used to identify patients with amyloid pathology associated with Alzheimer’s 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.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K252163](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/SET/K252163.md) | Elecsys Phospho-Tau (181P) Plasma | Roche Diagnostics | Oct 8, 2025 | SESE |
| [K242706](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/SET/K242706.md) | Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio | Fujirebio Diagnostics,Inc. | May 16, 2025 | SESE |

## Top Applicants

- Roche Diagnostics — 1 clearance
- Fujirebio Diagnostics,Inc. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/SET](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/SET)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com