Cleared Traditional

K122143 - VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER

K122143 is an FDA 510(k) clearance for VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHM..., 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 427-day FDA review.

K122143 · Ventana Medical Systems, Inc. · Pathology device
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Sep 2013
Decision
427d
Days
Class 2
Risk

K122143 is an FDA 510(k) clearance for the VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER. 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 19, 2013 after a review of 427 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

FDA 510(k) Submission Details - K122143

510(k) Number K122143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2012
Decision Date September 19, 2013
Days to Decision 427 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
350d slower than avg
Panel avg: 77d · This submission: 427d
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 K122143.
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