Cleared Traditional

K121456 - AUTION HYBRID AU-4050 FULLY AUTOMATED I...

Also marketed or referenced as:
URIFLET S 9HA URINE TEST STRIPS AUTION CONTROL

K121456 is an FDA 510(k) clearance for AUTION HYBRID AU-4050 FULLY AUTOMATED I..., manufactured by Arkray, Inc.. The device is a Class 1 Chemistry device with product code KQO cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K121456 · Arkray, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
261d
Days
Class 1
Risk

K121456 is an FDA 510(k) clearance for the AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM. Classified as Automated Urinalysis System (product code KQO), Class I - General Controls.

Submitted by Arkray, Inc. (Edina, US). The FDA issued a Cleared decision on February 1, 2013 after a review of 261 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2900 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Arkray, Inc. devices

FDA 510(k) Submission Details - K121456

510(k) Number K121456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2012
Decision Date February 01, 2013
Days to Decision 261 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
173d slower than avg
Panel avg: 88d · This submission: 261d
Pathway characteristics
Predicate-based equivalence.

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 K121456.
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