Product Classification

• Device: continuous glucose monitor secondary display
• Regulation Description: Continuous glucose monitor secondary alarm system.
• Definition: The purpose of the continuous glucose monitor secondary display is to notify another person, the follower, of the patient's continuous glucose monitoring system sensor glucose information in real time. The secondary display is intended for providing secondary notification of a continuous glucose monitoring system and does not replace primary real time continuous glucose monitoring or standard home blood glucose monitoring
• Physical State: Typically a software device installed on a third-party mobile device.
• Technical Method: Receives and displays real-time patient data from a continuous glucose monitor.
• Target Area: n/a
• Regulation Medical Specialty: Clinical Chemistry
• Review Panel: Clinical Chemistry
• Product Code: PJT
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Chemistry and Toxicology Devices (DCTD)
• Submission Type: 510(K) Exempt
• Regulation Number: 862.1350
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible

Note: Class II devices the Food and Drug Administration (FDA) has also published a list of class II (special controls) devices subject to certain limitations, that are exempt from premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the 21st Century Cures Act of 2016 (Cures Act). FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues. FDA is taking this action in order to meet requirements of FDAMA and the Cures Act.

• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

Not Third Party Eligible