Product Classification

• Device: sensor, glucose, invasive
• Definition: The device is a glucose-monitoring device indicated for detecting trends and tracking patterns in adults (age 18 and older) with diabetes. The device is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices. The system aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments.
• Review Panel: Clinical Chemistry
• Product Code: MDS
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Chemistry and Toxicology Devices (DCTD)
• Submission Type: PMA
• Device Class: 3
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 7-307 CLSI POCT05 2nd Edition
  Performance Metrics for Continuous Interstitial Glucose Monitoring
• 13-72 IEEE Std 11073-10425-2014
  Health informatics - Personal health device communication, Part 10425: Device Specialization - Continuous Glucose Monitor (CGM)
• 13-88 IEEE ISO 11073-10417 Third edition 2017-04
  Health informatics - Personal health device communication - Part 10417: Device specialization - Glucose meter
• 13-90 IEEE Std 11073-10417-2015
  Health Informatics - Personal Health Device Communication, Part 10417: Device Specialization - Glucose Meter
• 13-95 IEEE ISO 11073-10425 First edition 2016-06-15
  Health informatics - Personal health device communication - Part 10425: Device specialization - Continuous glucose monitor (CGM)

Third Party Review

Not Third Party Eligible