Cleared Traditional

VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) (K111755) - FDA 510(k) Clearance

K111755 · Ventana Medical Systems, Inc. · Pathology device
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Feb 2012
Decision
245d
Days
-
Risk

K111755 is an FDA 510(k) clearance for the VIRTUOSO SYSTEM FOR IHC KI-67 (30-9).

Submitted by Ventana Medical Systems, Inc. (Tucson, US). The FDA issued a Cleared decision on February 22, 2012 after a review of 245 days - an extended review cycle.

This device falls under the Pathology FDA review panel. 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 K111755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2011
Decision Date February 22, 2012
Days to Decision 245 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
168d slower than avg
Panel avg: 77d · This submission: 245d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NOT
Device Class -