Cleared Traditional

K121033 - VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) (FDA 510(k) Clearance)

K121033 · Ventana Medical Systems, Inc. · Pathology device
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Sep 2013
Decision
519d
Days
-
Risk

K121033 is an FDA 510(k) clearance for the VIRTUOSO SYSTEM FOR IHC KI-67 (30-9).

Submitted by Ventana Medical Systems, Inc. (Los Angeles, US). The FDA issued a Cleared decision on September 6, 2013 after a review of 519 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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

Submission Details

510(k) Number K121033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2012
Decision Date September 06, 2013
Days to Decision 519 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
442d slower than avg
Panel avg: 77d · This submission: 519d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NOT
Device Class -