Not Cleared Direct

DEN140016 - STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE (FDA 510(k) Clearance)

Class I Chemistry device.

DEN140016 · Dexcom, Inc. · Chemistry device
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Aug 2014
Decision
119d
Days
Class 1
Risk

DEN140016 is an FDA 510(k) submission (not cleared) for the STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE. Classified as Continuous Glucose Monitor Retrospective Data Analysis Software (product code PHV), Class I - General Controls.

Submitted by Dexcom, Inc. (San Diego, US). The FDA issued a Not Cleared (DENG) decision on August 19, 2014 after a review of 119 days.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2120 - 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.

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Submission Details

510(k) Number DEN140016 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received April 22, 2014
Decision Date August 19, 2014
Days to Decision 119 days
Submission Type Direct
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 88d · This submission: 119d
Pathway characteristics

Device Classification

Product Code PHV Continuous Glucose Monitor Retrospective Data Analysis Software
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2120
Definition Continuous Glucose Monitor Retrospective Data Analysis Software Is Intended To Analyze And Correlate Retrospective Data From A Continuous Glucose Monitoring Device.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.