Cleared Traditional

K140465 - VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER

K140465 is an FDA 510(k) clearance for VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH B..., 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 24-day FDA review.

K140465 · Ventana Medical Systems, Inc. · Pathology device
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Mar 2014
Decision
24d
Days
Class 2
Risk

K140465 is an FDA 510(k) clearance for the VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH 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. (Mountain View, US). The FDA issued a Cleared decision on March 20, 2014 after a review of 24 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ventana Medical Systems, Inc. devices

FDA 510(k) Submission Details - K140465

510(k) Number K140465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2014
Decision Date March 20, 2014
Days to Decision 24 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
53d faster than avg
Panel avg: 77d · This submission: 24d
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 K140465.
GENASIS HIPATH IHC FAMILY
K140957 · Applied Spectral Imaging , Ltd. · Jan 2015
VIRTUOSO SYSTEM FOR IHC ER (SPI)
K130515 · Ventana Medical Systems, Inc. · Nov 2013
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
VIRTUOSO SYSTEM FOR IHC PR (IE2)
K111869 · Ventana Medical Systems, Inc. · Mar 2012