Cleared Traditional

K061613 - VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5)

K061613 is an FDA 510(k) clearance for VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY..., manufactured by Tripath Imaging. The device is a Class 2 Pathology device with product code NQN cleared through the Traditional 510(k) pathway after a 215-day FDA review.

K061613 · Tripath Imaging · Pathology device
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Jan 2007
Decision
215d
Days
Class 2
Risk

K061613 is an FDA 510(k) clearance for the VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5). Classified as Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity (product code NQN), Class II - Special Controls.

Submitted by Tripath Imaging (Durham, US). The FDA issued a Cleared decision on January 10, 2007 after a review of 215 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 Tripath Imaging devices

FDA 510(k) Submission Details - K061613

510(k) Number K061613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2006
Decision Date January 10, 2007
Days to Decision 215 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 78d · This submission: 215d
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 12
Devices cleared under the same product code (NQN) and FDA review panel - the closest regulatory comparables to K061613.
VIRTUOSO SYSTEM FOR IHC PR (IE2)
K111869 · Ventana Medical Systems, Inc. · Mar 2012
PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67
K092333 · Bioimagene, Inc. · Oct 2010
SCANSCOPE XT SYSTEM
K073677 · Aperio Technologies · Aug 2008
VENTANA IMAGE ANALYSIS SYSTEM, MODEL VIAS
K062428 · Tripath Imaging, Inc. · Sep 2006
VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67
K053520 · Tripath Imaging, Inc. · Apr 2006
VENTANA IMAGE ANALYSIS SYSTEM
K050012 · Tripath Imaging, Inc. · May 2005