Integrated Continuous Glucose Monitoring System, Factory Calibrated

What Is It?

An integrated continuous glucose monitoring system (iCGM) is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing a disease or condition related to glycemic control.

What Is FDA Product Code QBJ?

Integrated Continuous Glucose Monitoring System, Factory Calibrated is FDA product code QBJ, Class 2, 21 CFR 862.1355.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.

What Has Gone Wrong With It?

The FDA has recorded 23 recalls under this product code since 2018. None was by a company in China. 10 are Class I, the most serious grade.

The root causes the FDA records most often are Software design (13), Nonconforming Material/Component (6) and Environmental control (1). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.