Cleared Traditional

K121516 - VIRTUOSO SYSTEM FOR IHC HER2 (4B5) (FDA 510(k) Clearance)

Class II Pathology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K121516 · Ventana Medical Systems, Inc. · Pathology device
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Sep 2013
Decision
492d
Days
Class 2
Risk

K121516 is an FDA 510(k) clearance for the VIRTUOSO SYSTEM FOR IHC HER2 (4B5). 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. (Los Angeles, US). The FDA issued a Cleared decision on September 26, 2013 after a review of 492 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Pathology submissions.

View all Ventana Medical Systems, Inc. devices

Submission Details

510(k) Number K121516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2012
Decision Date September 26, 2013
Days to Decision 492 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
415d slower than avg
Panel avg: 77d · This submission: 492d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.