Product Code: QII FDA class 2 21 CFR 862.1355

Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use

Clinical Chemistry

The Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use is a continuous glucose recording device intended for use either for real-time diabetes management at home or for retrospective discovery and analysis of glycemic variability in persons aged 2 and older, as directed by a physician, and is designed to interface with digitally connected devices. It is classified as FDA Class 2, requiring 510(k) clearance, regulated under 21 CFR 862.1355 within the Clinical Chemistry medical specialty. The product code is QII. The device is not an implant and is not flagged as life-sustaining.

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Basic Information

Product Code: QII
Device Class: FDA class 2
Regulation Number: 862.1355
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 1

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

Definition

An integrated continuous glucose monitoring system for professional directed retrospective or real-time use is a continuous glucose recording device indicated for use as directed by a physician either for the real-time management of diabetes at home or for the retrospective discovery, analysis, and interpretation of glycemic variability in persons age 2 and older by healthcare professionals to guide appropriate patient management. The system is also intended to interface with digitally connected devices.