SAF — Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter Class II
FDA product code SAF covers "Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter", a Class II medical device regulated under 21 CFR 862.1355. Submissions are reviewed by the Clinical Chemistry panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- SAF
- Device Class
- Class II
- Regulation Number
- 862.1355
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Definition
An integrated continuous glucose monitoring system (iCGM) for non-intensive glucose monitoring is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time to detect euglycemic and dysglycemic glucose levels in persons who are not on insulin and do not have a significant risk of problematic hypoglycemia. iCGM systems for non-intensive glucose monitoring are designed to reliably and securely transmit glucose measurement data to digitally connected devices, excluding devices intended to control the delivery of insulin, and are intended to be used alone or in conjunction with these digitally connected medical devices. Device output should not be used to make treatment decisions without consulting with a qualified healthcare professional.