# Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use
> **Product code: 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.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 7
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QII)
---
*AI Analytics · CC0 1.0*