Product Classification

• Device: automated insulin dosing , threshold suspend
• Definition: An automated insulin dosing system that temporarily suspends or reduces insulin infusion from an insulin pump based upon specified thresholds of measured glucose levels.
• Physical State: May include: Continuous glucose monitoring system, sensor, self monitoring blood glucose device, infusion pump, data management software
• Technical Method: Uses a glucose monitoring system to measure glucose levels in interstitial fluid or blood and suspends or reduces insulin infusion from an insulin pump
• Target Area: Not meant to act on a specific part of the body but works with other devices - Continuous glucose monitoring system, sensor, self monitoring blood glucose device, data managment software
• Review Panel: Clinical Chemistry
• Product Code: OZO
• 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
• 13-81 IEEE Std 11073-10419:2015
  Health informatics - Personal health device communication - Part 10419: Device Specialization - Insulin Pump
• 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
• 13-91 IEEE ISO 11073-10419 First edition 2016-06-15
  Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump

Third Party Review

Not Third Party Eligible