Cleared Traditional

K093555 - COBAS U411 TEST SYSTEM

K093555 is an FDA 510(k) clearance for COBAS U411 TEST SYSTEM, manufactured by Roche Diagnostics. The device is a Class 1 Chemistry device with product code KQO cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K093555 · Roche Diagnostics · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
136d
Days
Class 1
Risk

K093555 is an FDA 510(k) clearance for the COBAS U411 TEST SYSTEM. Classified as Automated Urinalysis System (product code KQO), Class I - General Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on April 2, 2010 after a review of 136 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K093555

510(k) Number K093555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2009
Decision Date April 02, 2010
Days to Decision 136 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 88d · This submission: 136d
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 44
Devices cleared under the same product code (KQO) and FDA review panel - the closest regulatory comparables to K093555.
CYBOW READER, MODELS 300 & 720
K102188 · DFI Co., Ltd. · Aug 2011
CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT
K101852 · Iris International Inc., A Division of Iris Iris I · Mar 2011
URITEST 50 AND URITEST 500 URINE ANALYZER
K091472 · Arj Medical, Inc. · Apr 2010
AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM
K093098 · Arkray, Inc. · Dec 2009
ACON U120 URINE ANALYZER, MODEL U111-101
K070929 · ACON Laboratories, Inc. · Jul 2007
HEMOCUE ALBUMIN 201 ANALYZING SYSTEM
K053253 · Hemocue AB · Feb 2006
K093555 · COBAS U411 TEST SYSTEM
Download PDF FDA Summary Roche Diagnostics