Cleared Special

K983510 - CHEMSTRIP 101 URINE ANALYZER

K983510 is an FDA 510(k) clearance for CHEMSTRIP 101 URINE ANALYZER, manufactured by Boehringer Mannheim Corp.. The device is a Class 1 Chemistry device with product code KQO cleared through the Special 510(k) pathway after a 20-day FDA review.

K983510 · Boehringer Mannheim Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
20d
Days
Class 1
Risk

K983510 is an FDA 510(k) clearance for the CHEMSTRIP 101 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 27, 1998 after a review of 20 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K983510

510(k) Number K983510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1998
Decision Date October 27, 1998
Days to Decision 20 days
Submission Type Special
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
68d faster than avg
Panel avg: 88d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

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 23
Devices cleared under the same product code (KQO) and FDA review panel - the closest regulatory comparables to K983510.
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
STC DIAGNOSTICS AUTO-LYTE URINARY LEUKOCYTE ESTERASE ASSAY
K954156 · Solarcare Technologies Corp,Inc. · Jul 1996
CLINITEK 50 URINE CHEMISTRY ANALYZER
K960546 · Bayer Corp. · Jun 1996
STC DIAGNOSTICS AUTO-LYTE PH ASSAY
K954158 · Solarcare Technologies Corp,Inc. · Apr 1996