QJI

22 FDA 510(k) clearances · Product code

FDA profile

Official device name

Interoperable Automated Glycemic Controller

Device class

Class II (moderate risk)

Regulation

21 CFR 862.1356

Medical specialty

Clinical Chemistry

FDA 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.

Adverse events (MAUDE)

2023: 26 · 2026: 2,959
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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