DeviceClearance

Product code QJI— Clinical Chemistry

Control-IQ Technology

Classification name
Interoperable Automated Glycemic Controller
Device class
Class 2
Regulation
21 CFR 862.1356
Advisory panel
Clinical Chemistry
Total cleared
23
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code QJI under 21 CFR 862.1356, via openFDA

Market context for product code QJI

FDA has cleared 23 devices under product code QJI between 2019 and 2026, filed by 9 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QJI

Adverse events under product code QJI

product code QJI
Other
3
Total
3

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code QJI

Data sourced from openFDA. This site is unofficial and independent of the FDA.