FDA product code QII: Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use
QII is the FDA product code for integrated continuous glucose monitoring system for professional directed retrospective or real-time use. It is a Class II device, regulated under 21 CFR 862.1355 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under QII. The average 510(k) review took 90 days (median 90).
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.
Classification
| Field | Value |
|---|---|
| Device name | Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use |
| Device class | Class II |
| Regulation | 21 CFR 862.1355 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
510(k) clearances per year for QII
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 90 |
Compare with all 510(k) review times · Search every QII clearance
Top QII applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dexcom, Inc. | 1 | 2019-10-07 |
Most recent QII clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K191833 | Dexcom, Inc. | Dexcom G6 Pro Continuous Glucose Monitoring System | 2019-10-07 | 90 |
Recalls for QII devices
openFDA lists no recalls for product code QII.
Frequently asked questions
What is FDA product code QII?
QII is the FDA product code for integrated continuous glucose monitoring system for professional directed retrospective or real-time use. It is a Class II device, regulated under 21 CFR 862.1355 and reviewed by the Clinical Chemistry panel.
What device class is QII?
Class II, regulation 21 CFR 862.1355. Typical premarket route: 510(k).
How long does a 510(k) take for product code QII?
Across 1 cleared submissions the average was 90 days from receipt to decision (median 90).
Which companies have the most QII clearances?
Dexcom, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QII
- Run a recall and safety report across every QII manufacturer
- Watch product code QII for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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