# Insulin Autoantibody Kit
> **Product code: OCN** · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.5660
## Classification
- **FDA Product Code:** OCN
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 866.5660
- **Review panel:** IM
- **Medical specialty:** Immunology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## Definition

The device is used for the semi-quantitative determination of insulin autoantibodies in human serum as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes) in patients who have not received insulin therapy.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 5
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OCN)
---
*AI Analytics · CC0 1.0*