# Interoperable Automated Glycemic Controller
> **Product code: QJI** · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.1356
## Classification
- **FDA Product Code:** QJI
- **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 is a device intended to automatically calculate drug doses based on inputs such as glucose and other relevant physiological parameters, and to command the delivery of such drug doses from a connected infusion pump. Interoperable automated glycemic controllers are designed to reliably and securely communicate with digitally connected devices to allow drug delivery commands to be sent, received, executed, and confirmed. Interoperable automated glycemic controllers are intended to be used in conjunction with digitally connected devices for the purpose of maintaining glycemic control.

## Market data
- **Cleared 510(k) submissions:** 20
- **Registered establishments:** 13
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QJI)
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