Cleared Traditional

K093555 - COBAS U411 TEST SYSTEM

K093555 is the FDA 510(k) clearance for COBAS U411 TEST SYSTEM by Roche Diagnostics. It is a Class 1 Chemistry device (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)
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.

View all Roche Diagnostics devices

Submission Details

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.

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.

Regulatory Peers - KQO Automated Urinalysis System

All 21
Devices cleared under the same product code (KQO) and FDA review panel - the closest regulatory comparables to K093555.
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
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
BAYER CLINITEK STATUS ANALYZER
K031947 · Bayer Healthcare, LLC · Dec 2003