Not Cleared Post-NSE

DEN140039 - NOVA View Automated Fluorescense Microscope

DEN140039 is an FDA 510(k) submission for NOVA View Automated Fluorescense Micr..., manufactured by Inova Diagnostics, Inc.. The device is a Class 2 Immunology device with product code PIV cleared through the Post-NSE 510(k) pathway after a 115-day FDA review.

DEN140039 · Inova Diagnostics, Inc. · Immunology device
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Apr 2015
Decision
115d
Days
Class 2
Risk

DEN140039 is an FDA 510(k) submission (not cleared) for the NOVA View Automated Fluorescense Microscope. Classified as Automated Indirect Immunofluorescence Microscope And Software-assisted System For Clinical Use (product code PIV), Class II - Special Controls.

Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Not Cleared (DENG) decision on April 9, 2015 after a review of 115 days.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.4750 - 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.

FDA 510(k) Submission Details - DEN140039

510(k) Number DEN140039 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 15, 2014
Decision Date April 09, 2015
Days to Decision 115 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
10d slower than avg
Panel avg: 105d · This submission: 115d
Pathway characteristics

PIV Device Classification - Class 2, Special Controls

Product Code PIV Automated Indirect Immunofluorescence Microscope And Software-assisted System For Clinical Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.4750
Definition Automated System Consisting Of A Fluorescence Microscope And Software That Acquires, Analyzes, Stores And Displays Digital Images Of Stained Indirect Immunofluorescent Slides. It Is Intended As An Aid In The Detection And Classification Of Certain Antibodies By Indirect Immunofluorescent Technology. A Trained Operator Must Confirm All Device Generated Results.
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.

DEN140039 · NOVA View Automated Fluorescense Microscope
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