Not Cleared Post-NSE

DEN040010 - VYSIS AUTOVYSION SYSTEM (FDA 510(k) Clearance)

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

DEN040010 · Vysis · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
61d
Days
Class 2
Risk

DEN040010 is an FDA 510(k) submission (not cleared) for the VYSIS AUTOVYSION SYSTEM. Classified as System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (fish) Assays (product code NTH), Class II - Special Controls.

Submitted by Vysis (Downers Grove, US). The FDA issued a Not Cleared (DENG) decision on December 13, 2004 after a review of 61 days.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 866.4700 - the FDA pathology 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 Pathology review framework.

View all Vysis devices

Submission Details

510(k) Number DEN040010 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received October 13, 2004
Decision Date December 13, 2004
Days to Decision 61 days
Submission Type Post-NSE
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 77d · This submission: 61d
Pathway characteristics

Device Classification

Product Code NTH System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (fish) Assays
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.4700
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 Pathology devices follow this clearance model.