Cleared Special

K093098 - AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM

K093098 is an FDA 510(k) clearance for AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM, manufactured by Arkray, Inc.. The device is a Class 1 Chemistry device with product code KQO cleared through the Special 510(k) pathway after a 83-day FDA review.

K093098 · Arkray, Inc. · Chemistry device
Download Printable Device Report (PDF)
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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

FDA 510(k) Submission Details - K093098

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.

KQO Device Classification - Class 1, General Controls

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.

Regulatory Peers - KQO Automated Urinalysis System

All 24
Devices cleared under the same product code (KQO) and FDA review panel - the closest regulatory comparables to K093098.
Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control
K142543 · ACON Laboratories, Inc. · May 2015
CLINITEK NOVUS
K140717 · Siemens Healthcare Diagnostics · Nov 2014
COBAS U411 TEST SYSTEM
K093555 · Roche Diagnostics · Apr 2010
ACON U120 URINE ANALYZER, MODEL U111-101
K070929 · ACON Laboratories, Inc. · Jul 2007
URITEK-720+ URINE ANALYZER
K051526 · Teco Diagnostics · Aug 2005
URITEK 151 URINE ANALYZER, MODEL TC-151
K042421 · Teco Diagnostics · May 2005