QBJ · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.1355
Classification
FDA Product Code
QBJ
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 862.1355
Review panel
CH
Medical specialty
Clinical Chemistry
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
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.