Cleared Abbreviated

K031363 - QCA (VERSION 3.1)

K031363 is an FDA 510(k) clearance for QCA (VERSION 3.1), manufactured by Cell Analysis, Inc.. The device is a Class 2 Pathology device with product code NQN cleared through the Abbreviated 510(k) pathway after a 281-day FDA review.

K031363 · Cell Analysis, Inc. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
281d
Days
Class 2
Risk

K031363 is an FDA 510(k) clearance for the QCA (VERSION 3.1). Classified as Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity (product code NQN), Class II - Special Controls.

Submitted by Cell Analysis, Inc. (Evanston, US). The FDA issued a Cleared decision on February 5, 2004 after a review of 281 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Cell Analysis, Inc. devices

FDA 510(k) Submission Details - K031363

510(k) Number K031363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2003
Decision Date February 05, 2004
Days to Decision 281 days
Submission Type Abbreviated
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
204d slower than avg
Panel avg: 77d · This submission: 281d
Pathway characteristics
Standards-based clearance path.

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 K031363.
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VIRTUOSO SYSTEM FOR IHC PR (IE2)
K111869 · Ventana Medical Systems, Inc. · Mar 2012