Not Cleared Post-NSE

DEN060001 - PHICAL TEST (FDA 510(k) Clearance)

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

DEN060001 · Genova Diagnostics · Immunology device
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Apr 2006
Decision
34d
Days
Class 2
Risk

DEN060001 is an FDA 510(k) submission (not cleared) for the PHICAL TEST. Classified as Calprotectin, Fecal (product code NXO), Class II - Special Controls.

Submitted by Genova Diagnostics (Asheville, US). The FDA issued a Not Cleared (DENG) decision on April 26, 2006 after a review of 34 days.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5180 - the FDA immunology 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 Immunology review framework.

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Submission Details

510(k) Number DEN060001 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received March 23, 2006
Decision Date April 26, 2006
Days to Decision 34 days
Submission Type Post-NSE
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 104d · This submission: 34d
Pathway characteristics

Device Classification

Product Code NXO Calprotectin, Fecal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5180
Definition The Device Is Used For The Measurement, In Human Stool, Of Fecal Calprotectin, A Neutrophilic Protein That Is A Marker Of Mucosal Inflammation. The Device Can Be Used As An Aid In The Diagnosis Of Inflammatory Bowel Disease (ibd), Crohn's Disease And Ulcerative Colitis And To Differentiate Ibd From Irritable Bowel Syndrome.
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 Immunology devices follow this clearance model.