Not Cleared Post-NSE

DEN120011 - PROTEUS INGESTION CONFINMATION SYSTEMS (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN120011 · Proteus Biomedical, Inc. · Gastroenterology & Urology device
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Jul 2012
Decision
60d
Days
Class 2
Risk

DEN120011 is an FDA 510(k) submission (not cleared) for the PROTEUS INGESTION CONFINMATION SYSTEMS. Classified as Ingestible Event Marker (product code OZW), Class II - Special Controls.

Submitted by Proteus Biomedical, Inc. (Redwood City, US). The FDA issued a Not Cleared (DENG) decision on July 10, 2012 after a review of 60 days.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 880.6305 - the FDA gastroenterology and urology device 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 Gastroenterology & Urology review framework.

View all Proteus Biomedical, Inc. devices

Submission Details

510(k) Number DEN120011 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received May 11, 2012
Decision Date July 10, 2012
Days to Decision 60 days
Submission Type Post-NSE
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 130d · This submission: 60d
Pathway characteristics

Device Classification

Product Code OZW Ingestible Event Marker
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6305
Definition To Provide Confirmation Of An Event Co-ingested Or Coincident With The Ingestible Component Of The Device. The Wearable Component Of The Device Incorporates Wireless Communication To Display The Event And Other Information On A General Computing Device
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 Gastroenterology & Urology devices follow this clearance model.