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QDKClass II

Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management

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

QDK is the FDA product code for Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management, 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 non-intensive diabetes management is intended to replace finger stick blood glucose testing for diabetes treatment decisions in persons with diabetes who do not have significant risk of severe hypoglycemia. The device also aids in the detection of episodes of...". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QDK
Device name
Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management
FDA definition
An integrated continuous glucose monitoring system for non-intensive diabetes management is intended to replace finger stick blood glucose testing for diabetes treatment decisions in persons with diabetes who do not have significant risk of severe hypoglycemia. The device also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating long-term therapy adjustments. The device is also intended to autonomously communicate with digitally connected devices. The device can be used alone or in conjunction with these digitally connected devices or services for the purpose of managing diabetes.
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
4
Ingested recalls
0

Clearances, product code QDK

By decision year
4 clearances under product code QDK with a decision year between 2018 and 2021, 2018 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QDK by decision year
YearClearances
20181
20191
20201
20211

Applicants with the most clearances

Product code QDK
Applicants holding the most 510(k) clearances under product code QDK
ApplicantClearances
Dexcom, Inc.4

Companies listing this code with FDA

Companies whose registered establishments list this code