Cleared Traditional

K092333 - PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67

K092333 is an FDA 510(k) clearance for PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67, manufactured by Bioimagene, Inc.. The device is a Class 2 Pathology device with product code NQN cleared through the Traditional 510(k) pathway after a 449-day FDA review.

K092333 · Bioimagene, Inc. · Pathology device
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Oct 2010
Decision
449d
Days
Class 2
Risk

K092333 is an FDA 510(k) clearance for the PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67. Classified as Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity (product code NQN), Class II - Special Controls.

Submitted by Bioimagene, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on October 27, 2010 after a review of 449 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Bioimagene, Inc. devices

FDA 510(k) Submission Details - K092333

510(k) Number K092333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2009
Decision Date October 27, 2010
Days to Decision 449 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
372d slower than avg
Panel avg: 77d · This submission: 449d
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

Devices cleared under the same product code (NQN) and FDA review panel - the closest regulatory comparables to K092333.
VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER
K122143 · Ventana Medical Systems, Inc. · Sep 2013
VIRTUOSO SYSTEM FOR IHC P53 (DO-7)
K111872 · Ventana Medical Systems, Inc. · Apr 2012
VIRTUOSO SYSTEM FOR IHC PR (IE2)
K111869 · Ventana Medical Systems, Inc. · Mar 2012