Cleared Traditional

K960546 - CLINITEK 50 URINE CHEMISTRY ANALYZER

K960546 is the FDA 510(k) clearance for CLINITEK 50 URINE CHEMISTRY ANALYZER by Bayer Corp.. It is a Class 1 Chemistry device (product code KQO) cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K960546 · Bayer Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
125d
Days
Class 1
Risk

K960546 is an FDA 510(k) clearance for the CLINITEK 50 URINE CHEMISTRY ANALYZER. Classified as Automated Urinalysis System (product code KQO), Class I - General Controls.

Submitted by Bayer Corp. (Elkhart, US). The FDA issued a Cleared decision on June 12, 1996 after a review of 125 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 K960546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1996
Decision Date June 12, 1996
Days to Decision 125 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
37d slower than avg
Panel avg: 88d · This submission: 125d
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 K960546.
URITEK 151 URINE ANALYZER, MODEL TC-151
K042421 · Teco Diagnostics · May 2005
BAYER CLINITEK STATUS ANALYZER
K031947 · Bayer Healthcare, LLC · Dec 2003
CHEMSTRIP 101 URINE ANALYZER
K983510 · Boehringer Mannheim Corp. · Oct 1998
CHEMSTRIP CRITERION URINE ANALYZER
K954024 · Boehringer Mannheim Corp. · Oct 1995
CLINITEK ATLAS AUTOMATED URINE CHEMISTRY ANALYZER
K946183 · Heraeus Kulzer, Inc. · Feb 1995
CHEMSTRIP MINI UA URINE ANALYZER
K943592 · Boehringer Mannheim Corp. · Nov 1994