Cleared Traditional

K142965 - Virtuoso System for IHC PR (1E2) using iScan HT (FDA 510(k) Clearance)

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

K142965 · Ventana Medical Systems, Inc. · Pathology device
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Jul 2015
Decision
275d
Days
Class 2
Risk

K142965 is an FDA 510(k) clearance for the Virtuoso System for IHC PR (1E2) using iScan HT. Classified as Automated Digital Image Manual Interpretation Microscope (product code OEO), Class II - Special Controls.

Submitted by Ventana Medical Systems, Inc. (Mountain View, US). The FDA issued a Cleared decision on July 16, 2015 after a review of 275 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

Submission Details

510(k) Number K142965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2014
Decision Date July 16, 2015
Days to Decision 275 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
198d slower than avg
Panel avg: 77d · This submission: 275d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OEO Automated Digital Image Manual Interpretation Microscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.1860
Definition The Ihc Her2 Manual Read Of A Digital Slide Application Is Intended For Use As An Aid To The Pathologist In The Detection And Semi-quantitative Measurement Of Her2/neu (c-erbb-2) In Formalin-fixed, Paraffin-embedded Normal And Neoplastic Tissue Immunohistochemically Stained For Her-2 Receptors, Using Microscopy Images Displayed On A Computer Monitor. Her-2 Results Are Indicated For Use As An Aid In The Management, Prognosis And Prediction Of Therapy Outcomes In Breast Cancer.
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.