Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter
SAF · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.1355
Classification
FDA Product Code
SAF
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 (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.