Product Classification

• Device: integrated continuous glucose monitor for non-intensive glucose monitoring, over-the-counter
• Regulation Description: Integrated continuous glucose monitoring system.
• 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. They are not intended to provide alerts or alarms to users regarding measured glucose levels. Device output should not be used to make treatment decisions without consulting with a qualified healthcare professional.
• Physical State: Glucose sensor, including a mechanism for recording and/or displaying measured glucose values such as a transmitter, and a primary receiver. The device contains software to calculate glucose values.
• Technical Method: A glucose sensor applied at home by the end user used to monitor glucose levels
• Target Area: Diagnostics
• Regulation Medical Specialty: Clinical Chemistry
• Review Panel: Clinical Chemistry
• Product Code: SAF
• Premarket Review: Division of Chemistry and Toxicology Devices (DCTD); Division of Chemistry and Toxicology Devices (DCTD)
• Submission Type: 510(k)
• Regulation Number: 862.1355
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

Not Third Party Eligible