Not Cleared Post-NSE

DEN040007 - VERICHIP HEALTH INFORMATION MICROTRANSPONDER AND POCKET READER

DEN040007 is an FDA 510(k) submission for VERICHIP HEALTH INFORMATION MICROTRAN..., manufactured by Digital Angel Corporation. The device is a Class 2 General Hospital device with product code NRV cleared through the Post-NSE 510(k) pathway after a 69-day FDA review.

DEN040007 · Digital Angel Corporation · General Hospital
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Oct 2004
Decision
69d
Days
Class 2
Risk

DEN040007 is an FDA 510(k) submission (not cleared) for the VERICHIP HEALTH INFORMATION MICROTRANSPONDER AND POCKET READER. Classified as Implantable Radio Frequency Transponder System (product code NRV), Class II - Special Controls.

Submitted by Digital Angel Corporation (South St. Paul, US). The FDA issued a Not Cleared (DENG) decision on October 12, 2004 after a review of 69 days.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6300 - the FDA general hospital 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 General Hospital review framework.

FDA 510(k) Submission Details - DEN040007

510(k) Number DEN040007 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received August 04, 2004
Decision Date October 12, 2004
Days to Decision 69 days
Submission Type Post-NSE
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 129d · This submission: 69d
Pathway characteristics

NRV Device Classification - Class 2, Special Controls

Product Code NRV Implantable Radio Frequency Transponder System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6300
Definition An Implantable Microtransponder System Intended To Facilitate Access To Identification And Health Information In Humans. It Is Described As Consisting Of A Small Implantable Electronic Microtransponder, An Insertion Device (introducer), And An Electronic Scanner (pocket Reader). The Microtransponder Is A Passive Device That Contains An Electronic Circuit, Which Is Activated Externally By A Low-powered Radio Beam Sent By A Handheld, Battery-powered Pocket Reader. The Microtransponder Stores Only A Unique Electronic Identification Number (id). The Id Number Is Used To Access A Database That Provides The Implanted Person's Identity And Health Information Supplied By The Patient
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 General Hospital devices follow this clearance model.

DEN040007 · VERICHIP HEALTH INFORMATION MICROTRANSPONDER AND POCKET READER
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