Definition: An Integrated Continuous Glucose Monitoring System For Non-intensive Diabetes Management Is Intended To Replace Finger Stick Blood Glucose Testing For Diabetes Treatment Decisions In Persons With Diabetes Who Do Not Have Significant Risk Of Severe Hy
| Device Type ID | 684 |
| Device Name | Integrated Continuous Glucose Monitoring System For Non-intensive Diabetes Management |
| Physical State | Glucose Sensor, A Transmitter, And A Primary Receiver. The Device Contains Software To Calculate Glucose Values. |
| Technical Method | A Transcutaneous Glucose Sensor Which Is Factory Calibrated. The Sensor Is Inserted At Home By The End User, And Is Used In Conjunction With The Associated Transmitter And Receiver To Monitor Glucose Levels For The Management Of Diabetes. |
| Target Area | Diagnosis, Monitoring |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Submission Type | 510(k) |
| CFR Regulation Number | 862.1355 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QDK |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 684 |
| Device | Integrated Continuous Glucose Monitoring System For Non-intensive Diabetes Management |
| Product Code | QDK |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 862.1355 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DEXCOM, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Displays Incorrect Message | 1 |
Retraction Problem | 1 |
| Total Device Problems | 2 |