Cleared Traditional

K111869 - VIRTUOSO SYSTEM FOR IHC PR (IE2)

K111869 is an FDA 510(k) clearance for VIRTUOSO SYSTEM FOR IHC PR (IE2), manufactured by Ventana Medical Systems, Inc.. The device is a Class 2 Pathology device with product code NQN cleared through the Traditional 510(k) pathway after a 248-day FDA review.

K111869 · Ventana Medical Systems, Inc. · Pathology device
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Mar 2012
Decision
248d
Days
Class 2
Risk

K111869 is an FDA 510(k) clearance for the VIRTUOSO SYSTEM FOR IHC PR (IE2). Classified as Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity (product code NQN), Class II - Special Controls.

Submitted by Ventana Medical Systems, Inc. (Tucson, US). The FDA issued a Cleared decision on March 5, 2012 after a review of 248 days - an extended review cycle.

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 Ventana Medical Systems, Inc. devices

FDA 510(k) Submission Details - K111869

510(k) Number K111869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2011
Decision Date March 05, 2012
Days to Decision 248 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
171d slower than avg
Panel avg: 77d · This submission: 248d
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

All 7
Devices cleared under the same product code (NQN) and FDA review panel - the closest regulatory comparables to K111869.
VIRTUOSO SYSTEM FOR IHC HER2 (4B5)
K121516 · Ventana Medical Systems, Inc. · Sep 2013
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
VENTANA IMAGE ANALYSIS SYSTEM
K050012 · Tripath Imaging, Inc. · May 2005