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.