Not Cleared Direct

DEN170088 - Dexcom G6 Continuous Glucose Monitoring System (FDA 510(k) Clearance)

Class II Chemistry device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN170088 · Dexcom, Inc. · Chemistry device
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Mar 2018
Decision
109d
Days
Class 2
Risk

DEN170088 is an FDA 510(k) submission (not cleared) for the Dexcom G6 Continuous Glucose Monitoring System. Classified as Integrated Continuous Glucose Monitoring System, Factory Calibrated (product code QBJ), Class II - Special Controls.

Submitted by Dexcom, Inc. (San Diego, US). The FDA issued a Not Cleared (DENG) decision on March 27, 2018 after a review of 109 days.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1355 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Chemistry review framework.

View all Dexcom, Inc. devices

Submission Details

510(k) Number DEN170088 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 08, 2017
Decision Date March 27, 2018
Days to Decision 109 days
Submission Type Direct
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 88d · This submission: 109d
Pathway characteristics

Device Classification

Product Code QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1355
Definition An Integrated Continuous Glucose Monitoring System (icgm) Is Intended To Automatically Measure Glucose In Bodily Fluids Continuously Or Frequently For A Specified Period Of Time. Icgm Systems Are Designed To Reliably And Securely Transmit Glucose Measurement Data To Digitally Connected Devices, Including Automated Insulin Dosing Systems, And Are Intended To Be Used Alone Or In Conjunction With These Digitally Connected Medical Devices For The Purpose Of Managing A Disease Or Condition Related To Glycemic Control.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated

All 16
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