Product Code: KQO FDA class 1 21 CFR 862.2900

Automated Urinalysis System

Clinical Chemistry

This device is an automated urinalysis system used to analyze urine samples for physical, chemical, and microscopic characteristics, supporting the diagnosis of urinary tract infections, kidney disease, diabetes, and other conditions. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is KQO, regulated under 21 CFR 862.2900 within the Clinical Chemistry specialty. No special flags apply.

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FEI Numbers

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Basic Information

Product Code: KQO
Device Class: FDA class 1
Regulation Number: 862.2900
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 46 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K141874	URISCAN OPTIMA	May 28, 2015	Substantially Equivalent	Yd Diagnostics Corp.
K142543	Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control	May 11, 2015	Substantially Equivalent	ACON Laboratories, Inc.
K140717	CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT	Nov 17, 2014	Substantially Equivalent	Siemens Healthcare Diagnostics
K121456	AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL	Feb 01, 2013	Substantially Equivalent	Arkray, Inc.
K102188	CYBOW READER, MODELS 300 & 720	Aug 09, 2011	Substantially Equivalent	DFI Co., Ltd.
K101852	CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT	Mar 23, 2011	Substantially Equivalent	Iris International Inc., A Division of Iris Iris I
K091472	URITEST 50 AND URITEST 500 URINE ANALYZER	Apr 27, 2010	Substantially Equivalent	Arj Medical, Inc.
K093555	COBAS U411 TEST SYSTEM	Apr 02, 2010	Substantially Equivalent	Roche Diagnostics
K093098	AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM	Dec 23, 2009	Substantially Equivalent	Arkray, Inc.
K070929	ACON U120 URINE ANALYZER, MODEL U111-101	Jul 30, 2007	Substantially Equivalent	ACON Laboratories, Inc.
K053253	HEMOCUE ALBUMIN 201 ANALYZING SYSTEM	Feb 17, 2006	Substantially Equivalent	Hemocue AB
K051526	URITEK-720+ URINE ANALYZER	Aug 16, 2005	Substantially Equivalent	Teco Diagnostics
K042421	URITEK 151 URINE ANALYZER, MODEL TC-151	May 09, 2005	Substantially Equivalent	Teco Diagnostics
K031947	BAYER CLINITEK STATUS ANALYZER	Dec 19, 2003	Substantially Equivalent	Bayer Healthcare, LLC
K030600	AUTION JET AJ-4270 URINE ANALYZER	Jul 11, 2003	Substantially Equivalent	International Remote Imaging Systems
K013783	AUTION MAX AX-4280 URINALYSIS SYSTEM	Jan 18, 2002	Substantially Equivalent	International Remote Imaging Systems
K012829	STRIPMAX 1210 URINE CHEMISTRY ANALYZER, URIMATE REAGENT STRIP FOR URINALYSIS	Nov 02, 2001	Substantially Equivalent	Biocare Corp.
K983510	CHEMSTRIP 101 URINE ANALYZER	Oct 27, 1998	Substantially Equivalent	Boehringer Mannheim Corp.
K980047	URISCAN S-300 SEMI-AUTOMATED URINE CHEMISTRY ANALYZER	Jun 10, 1998	Substantially Equivalent	Yeongdong Pharmaceutical Corp.
K972141	THE YELLOW IRIS URINALYSIS WORKSTATION	Aug 25, 1997	Substantially Equivalent	Intl. Remote Imaging Systems
K954156	STC DIAGNOSTICS AUTO-LYTE URINARY LEUKOCYTE ESTERASE ASSAY	Jul 22, 1996	Substantially Equivalent	Solarcare Technologies Corp,Inc.
K954514	UA PERFECT AUTOMATED ANALYSIS ASSAY FOR UROBILLINOGEN IN URINE	Jun 21, 1996	Substantially Equivalent	Sciteck Diagnostics, Inc.
K960546	CLINITEK 50 URINE CHEMISTRY ANALYZER	Jun 12, 1996	Substantially Equivalent	Bayer Corp.
K951877	AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINE	May 14, 1996	Substantially Equivalent	Chimera Research & Chemical, Inc.
K954158	STC DIAGNOSTICS AUTO-LYTE PH ASSAY	Apr 30, 1996	Substantially Equivalent	Solarcare Technologies Corp,Inc.
K960054	900UDX URINE PATHOLOGY SYSTEM	Mar 22, 1996	Substantially Equivalent	Intl. Remote Imaging Systems
K954024	CHEMSTRIP CRITERION URINE ANALYZER	Oct 23, 1995	Substantially Equivalent	Boehringer Mannheim Corp.
K946183	CLINITEK ATLAS AUTOMATED URINE CHEMISTRY ANALYZER	Feb 22, 1995	Substantially Equivalent	Heraeus Kulzer, Inc.
K943592	CHEMSTRIP MINI UA URINE ANALYZER	Nov 08, 1994	Substantially Equivalent	Boehringer Mannheim Corp.
K943463	THE YELLOW IRIS	Sep 20, 1994	Substantially Equivalent	Intl. Remote Imaging Systems
K935408	UA PERFECT	Jun 13, 1994	Substantially Equivalent	Chimera Research & Chemical, Inc.
K934042	CHEMSTRIP SUPER UA URINE ANALYZER	Oct 14, 1993	Substantially Equivalent	Boehringer Mannheim Corp.
K932674	CLINITEK ATLAS AUTOMATED URINE CHEMISTRY SYSTEM	Aug 19, 1993	Substantially Equivalent	Miles Inc., Dental Products
K931602	CHEMSTRIP URINE ANALYZER	Jun 15, 1993	Substantially Equivalent	Boehringer Mannheim Corp.
K926359	CLINITEK 200+ URINE CHEMISTRY ANALYZER	Jan 28, 1993	Substantially Equivalent	Heraeus Kulzer, Inc.
K921087	CHEMSTRIP URINE ANALYZER	Mar 24, 1992	Substantially Equivalent	Boehringer Mannheim Corp.
K870526	SUPER URINE ANALYZER SYSTEM	Mar 06, 1987	Substantially Equivalent	Kyoto Daiichi Kagaku Co., Ltd.
K841041	CLINI-TEK AUTO 2000 REFLECTANCE SPECTR	Aug 24, 1984	Substantially Equivalent	Miles Laboratories, Inc.
K842237	CLINITEK 200 SEMI-AUTOMATED URINALYSIS	Aug 15, 1984	Substantially Equivalent	Miles Laboratories, Inc.
K842238	CLINITEK 10 SEMI-AUTO URINALYSIS SYS	Jul 25, 1984	Substantially Equivalent	Miles Laboratories, Inc.
K840996	URINE ANALYZER SYSTEM	May 01, 1984	Substantially Equivalent	Kyoto Diagnostics, Inc.
K830220	YELLOW IRIS TM	Jun 17, 1983	Substantially Equivalent	Intl. Remote Imaging Systems
K821738	CLINI-TEK SEMI-AUTOMATED URINALYSIS SYST	Jul 06, 1982	Substantially Equivalent	Miles Laboratories, Inc.
K813056	AUTOMATED URINALYSIS SYSTEM	May 05, 1982	Substantially Equivalent	Kyoto Daiichi Kagaku Co., Ltd.
K761306	CLINILAB AUTOMATED URINALYSIS SYSTEM	Mar 21, 1977	Substantially Equivalent	Miles Laboratories, Inc.
K760472	INSTRUMENTED SYSTEM FOR URINALYSIS	Oct 29, 1976	Substantially Equivalent	Miles Laboratories, Inc.