KQO · Automated Urinalysis System
Clinical Chemistry · 21 CFR 862.2900 · Class 1
Overview
| Product Code | KQO |
|---|---|
| Device Name | Automated Urinalysis System |
| Regulation | 21 CFR 862.2900 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
An automated urinalysis system is a device intended to measure certain of the physical properties and chemical constituents of urine by procedures that duplicate manual urinalysis systems. This device is used in conjunction with certain materials to measure a variety of urinary analytes.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Recent Cleared Devices (20 of 46)
Showing 20 most recent of 46 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K141874 | URISCAN OPTIMA | Yd Diagnostics Corp. | May 28, 2015 | SESE |
| K142543 | Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control | ACON Laboratories, Inc. | May 11, 2015 | SESE |
| K140717 | CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT | Siemens Healthcare Diagnostics | Nov 17, 2014 | SESE |
| K121456 | AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL | Arkray, Inc. | Feb 1, 2013 | SESE |
| K102188 | CYBOW READER, MODELS 300 & 720 | DFI Co., Ltd. | Aug 9, 2011 | SESE |
| K101852 | CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT | Iris International Inc., A Division of Iris Iris I | Mar 23, 2011 | SESE |
| K091472 | URITEST 50 AND URITEST 500 URINE ANALYZER | Arj Medical, Inc. | Apr 27, 2010 | SESE |
| K093555 | COBAS U411 TEST SYSTEM | Roche Diagnostics | Apr 2, 2010 | SESE |
| K093098 | AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM | Arkray, Inc. | Dec 23, 2009 | SESE |
| K070929 | ACON U120 URINE ANALYZER, MODEL U111-101 | ACON Laboratories, Inc. | Jul 30, 2007 | SESE |
| K053253 | HEMOCUE ALBUMIN 201 ANALYZING SYSTEM | Hemocue AB | Feb 17, 2006 | SESE |
| K051526 | URITEK-720+ URINE ANALYZER | Teco Diagnostics | Aug 16, 2005 | SESE |
| K042421 | URITEK 151 URINE ANALYZER, MODEL TC-151 | Teco Diagnostics | May 9, 2005 | SESE |
| K031947 | BAYER CLINITEK STATUS ANALYZER | Bayer Healthcare, LLC | Dec 19, 2003 | SESE |
| K030600 | AUTION JET AJ-4270 URINE ANALYZER | International Remote Imaging Systems | Jul 11, 2003 | SESE |
| K013783 | AUTION MAX AX-4280 URINALYSIS SYSTEM | International Remote Imaging Systems | Jan 18, 2002 | SESE |
| K012829 | STRIPMAX 1210 URINE CHEMISTRY ANALYZER, URIMATE REAGENT STRIP FOR URINALYSIS | Biocare Corp. | Nov 2, 2001 | SESE |
| K983510 | CHEMSTRIP 101 URINE ANALYZER | Boehringer Mannheim Corp. | Oct 27, 1998 | SESE |
| K980047 | URISCAN S-300 SEMI-AUTOMATED URINE CHEMISTRY ANALYZER | Yeongdong Pharmaceutical Corp. | Jun 10, 1998 | SESE |
| K972141 | THE YELLOW IRIS URINALYSIS WORKSTATION | Intl. Remote Imaging Systems | Aug 25, 1997 | SESE |
Top Applicants
- Boehringer Mannheim Corp. — 6 clearances
- Miles Laboratories, Inc. — 6 clearances
- Intl. Remote Imaging Systems — 4 clearances
- ACON Laboratories, Inc. — 2 clearances
- Arkray, Inc. — 2 clearances
