Cleared Traditional

K111755 - VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)

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

FDA 510(k) Submission Details - K111755

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
168d slower than avg
Panel avg: 77d · This submission: 245d
Pathway characteristics
Predicate-based equivalence.

NOT Device Classification - Class ,

Product Code NOT
Device Class -

Regulatory Peers - NOT

Devices cleared under the same product code (NOT) and FDA review panel - the closest regulatory comparables to K111755.
APERIO EPATHOLOGY EIHC IVD SYSTEM
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