Cleared Special

K093098 - AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM (FDA 510(k) Clearance)

Class I Chemistry device.

K093098 · Arkray, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
83d
Days
Class 1
Risk

K093098 is an FDA 510(k) clearance for the AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM. Classified as Automated Urinalysis System (product code KQO), Class I - General Controls.

Submitted by Arkray, Inc. (Richardson, US). The FDA issued a Cleared decision on December 23, 2009 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2900 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Arkray, Inc. devices

Submission Details

510(k) Number K093098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2009
Decision Date December 23, 2009
Days to Decision 83 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 88d · This submission: 83d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KQO Automated Urinalysis System
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2900
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.