Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use
QII · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.1355
Classification
FDA Product Code
QII
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 for professional directed retrospective or real-time use is a continuous glucose recording device indicated for use as directed by a physician either for the real-time management of diabetes at home or for the retrospective discovery, analysis, and interpretation of glycemic variability in persons age 2 and older by healthcare professionals to guide appropriate patient management. The system is also intended to interface with digitally connected devices.