Cleared Abbreviated

K031363 - QCA (VERSION 3.1) (FDA 510(k) Clearance)

Class II Pathology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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.