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QIIClass II

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

21 CFR 862.1355 / Clinical Chemistry
FDA source (opens on fda.gov)

QII is the FDA product code for Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use, a class II device type, regulated under 21 CFR 862.1355. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QII
Device name
Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use
FDA 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.
Regulation
21 CFR 862.1355
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QII

By decision year
1 clearance under product code QII with a decision year between 2019 and 2019, 2019 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QII by decision year
YearClearances
20191

Applicants with the most clearances

Product code QII
Applicants holding the most 510(k) clearances under product code QII
ApplicantClearances
Dexcom, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code