Cleared Traditional

K050012 - VENTANA IMAGE ANALYSIS SYSTEM

K050012 is an FDA 510(k) clearance for VENTANA IMAGE ANALYSIS SYSTEM, manufactured by Tripath Imaging, Inc.. The device is a Class 2 Pathology device with product code NQN cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K050012 · Tripath Imaging, Inc. · Pathology device
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May 2005
Decision
123d
Days
Class 2
Risk

K050012 is an FDA 510(k) clearance for the VENTANA IMAGE ANALYSIS SYSTEM. Classified as Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity (product code NQN), Class II - Special Controls.

Submitted by Tripath Imaging, Inc. (Burlington, US). The FDA issued a Cleared decision on May 6, 2005 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.1860 - the FDA pathology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Tripath Imaging, Inc. devices

FDA 510(k) Submission Details - K050012

510(k) Number K050012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2005
Decision Date May 06, 2005
Days to Decision 123 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 77d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NQN Device Classification - Class 2, Special Controls

Product Code NQN Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.1860
Definition Automated Microscopic Immunohistochemistry Image- Analysis System To Measure Nuclear Intensity And Percent Positivity With Operator Intervention.
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.

Regulatory Peers - NQN Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity

Devices cleared under the same product code (NQN) and FDA review panel - the closest regulatory comparables to K050012.
VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER
K122143 · Ventana Medical Systems, Inc. · Sep 2013
VIRTUOSO SYSTEM FOR IHC P53 (DO-7)
K111872 · Ventana Medical Systems, Inc. · Apr 2012
VIRTUOSO SYSTEM FOR IHC PR (IE2)
K111869 · Ventana Medical Systems, Inc. · Mar 2012