# Immunoassay Blood Test For Amyloid Pathology Assessment
> **Product code: SET** · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.5840
## Classification
- **FDA Product Code:** SET
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 866.5840
- **Review panel:** IM
- **Medical specialty:** Immunology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

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.

## Market data
- **Cleared 510(k) submissions:** 2
- **Registered establishments:** 4
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=SET)
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