# Interoperable Automated Glycemic Controller, Insulin Suspend
> **Product code: QJS** · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.1356
## Classification
- **FDA Product Code:** QJS
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 862.1356
- **Review panel:** CH
- **Medical specialty:** Clinical Chemistry
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

An interoperable automated glycemic controller, insulin suspend, is a device that temporarily suspend and resumes  insulin infusion from a connected infusion pump based on specified thresholds and input glucose levels. Interoperable automated glycemic controllers, insulin suspend, are designed to reliably and securely communicate with digitally connected devices to allow insulin delivery suspension and resumption commands to be sent, received, executed, and confirmed. Interoperable automated glycemic controllers, insulin suspend, are intended to be used in conjunction with digitally connected devices for the purpose of maintaining glycemic control.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 4
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QJS)
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