Cleared Traditional

COBAS U411 TEST SYSTEM (K093555) - FDA 510(k) Clearance

Class I Chemistry device.

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.

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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
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 45
Devices cleared under the same product code (KQO) and FDA review panel - the closest regulatory comparables to K093555.
CHEMSTRIP 101 URINE ANALYZER
K983510 · Boehringer Mannheim Corp. · Oct 1998
CHEMSTRIP CRITERION URINE ANALYZER
K954024 · Boehringer Mannheim Corp. · Oct 1995
CHEMSTRIP MINI UA URINE ANALYZER
K943592 · Boehringer Mannheim Corp. · Nov 1994
CHEMSTRIP SUPER UA URINE ANALYZER
K934042 · Boehringer Mannheim Corp. · Oct 1993
CHEMSTRIP URINE ANALYZER
K931602 · Boehringer Mannheim Corp. · Jun 1993
CHEMSTRIP URINE ANALYZER
K921087 · Boehringer Mannheim Corp. · Mar 1992