Cleared Traditional

CHEMSTRIP CRITERION URINE ANALYZER (K954024) - FDA 510(k) Clearance

Class I Chemistry device.

K954024 · Boehringer Mannheim Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
56d
Days
Class 1
Risk

K954024 is an FDA 510(k) clearance for the CHEMSTRIP CRITERION URINE ANALYZER. Classified as Automated Urinalysis System (product code KQO), Class I - General Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on October 23, 1995 after a review of 56 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Boehringer Mannheim Corp. devices

Submission Details

510(k) Number K954024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1995
Decision Date October 23, 1995
Days to Decision 56 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
32d faster than avg
Panel avg: 88d · This submission: 56d
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 14
Devices cleared under the same product code (KQO) and FDA review panel - the closest regulatory comparables to K954024.
COBAS U411 TEST SYSTEM
K093555 · Roche Diagnostics · Apr 2010
CHEMSTRIP 101 URINE ANALYZER
K983510 · Boehringer Mannheim Corp. · Oct 1998
CLINITEK ATLAS AUTOMATED URINE CHEMISTRY ANALYZER
K946183 · Heraeus Kulzer, Inc. · Feb 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