Automated Urinalysis System
FDA product code KQO · Class I (low risk) · 21 CFR 862.2900 · Clinical Chemistry
46510(k) clearances
0PMA approvals
31recalls
Manufacturers
- Miles Laboratories, Inc. 6
- Boehringer Mannheim Corp. 6
- Intl. Remote Imaging Systems 4
- Kyoto Daiichi Kagaku Co., Ltd. 2
- Heraeus Kulzer, Inc. 2
- Chimera Research & Chemical, Inc. 2
- Solarcare Technologies Corp,Inc. 2
- Arkray, Inc. 2
- ACON Laboratories, Inc. 2
- Teco Diagnostics 2
- International Remote Imaging Systems 2
- Yd Diagnostics Corp. 1
- Roche Diagnostics Corp. 1
- Hemocue, Inc. 1
- Bayer Healthcare, LLC 1
- Biocare Corp. 1
- Yeongdong Pharmaceutical Corp. 1
- Sciteck Diagnostics, Inc. 1
- Bayer Corp. 1
- Miles Inc., Dental Products 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K141874 | Uriscan OptimaKQO · Traditional | Yd Diagnostics Corp. | 05/28/2015SE |
| K142543 | Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube…KQO · Traditional | ACON Laboratories, Inc. | 05/11/2015SE |
| K140717 | Clinitek Novus; Automated Urine Chemistry Analyzer, 10 Urinalysis Cassette, Calibration…KQO · Traditional | Siemens Healthcare Diagnostics | 11/17/2014SE |
| K121456 | Aution Hybrid AU-4050 Fully Automated Integrated Urine Analyzer System; Uriflet S 9HA…KQO · Traditional | Arkray, Inc. | 02/01/2013SE |
| K102188 | Cybow Reader, Models 300 & 720KQO · Traditional | DFI Co., Ltd. | 08/09/2011SE |
| K101852 | Chem Velocity Automated Urine Chemistry System, Strips and Calchek KitKQO · Traditional | Iris International Inc., A Division of Iris Iris I | 03/23/2011SE |
| K091472 | Uritest 50 and Uritest 500 Urine AnalyzerKQO · Traditional | Arj Medical, Inc. | 04/27/2010SE |
| K093555 | Cobas U411 Test SystemKQO · Traditional | Roche Diagnostics | 04/02/2010SE |
| K093098 | Aution Max Model AX-4030 Urinalysis SystemKQO · Special | Arkray, Inc. | 12/23/2009SE |
| K070929 | Acon U120 Urine Analyzer, Model U111-101KQO · Traditional | ACON Laboratories, Inc. | 07/30/2007SE |
| K053253 | Hemocue Albumin 201 Analyzing SystemKQO · Traditional | Hemocue AB | 02/17/2006SE |
| K051526 | URITEK-720+ Urine AnalyzerKQO · Traditional | Teco Diagnostics | 08/16/2005SE |
| K042421 | Uritek 151 Urine Analyzer, Model TC-151KQO · Traditional | Teco Diagnostics | 05/09/2005SE |
| K031947 | Bayer Clinitek Status AnalyzerKQO · Traditional | Bayer Healthcare, LLC | 12/19/2003SE |
| K030600 | Aution Jet AJ-4270 Urine AnalyzerKQO · Traditional | International Remote Imaging Systems | 07/11/2003SE |
| K013783 | Aution Max AX-4280 Urinalysis SystemKQO · Traditional | International Remote Imaging Systems | 01/18/2002SE |
| K012829 | Stripmax 1210 Urine Chemistry Analyzer, Urimate Reagent Strip for UrinalysisKQO · Traditional | Biocare Corp. | 11/02/2001SE |
| K983510 | Chemstrip 101 Urine AnalyzerKQO · Special | Boehringer Mannheim Corp. | 10/27/1998SE |
| K980047 | Uriscan S-300 Semi-Automated Urine Chemistry AnalyzerKQO · Traditional | Yeongdong Pharmaceutical Corp. | 06/10/1998SE |
| K972141 | The Yellow Iris Urinalysis WorkstationKQO · Traditional | Intl. Remote Imaging Systems | 08/25/1997SE |
| K954156 | STC Diagnostics Auto-Lyte Urinary Leukocyte Esterase AssayKQO · Traditional | Solarcare Technologies Corp,Inc. | 07/22/1996SE |
| K954514 | Ua Perfect Automated Analysis Assay for Urobillinogen in UrineKQO · Traditional | Sciteck Diagnostics, Inc. | 06/21/1996SE |
| K960546 | Clinitek 50 Urine Chemistry AnalyzerKQO · Traditional | Bayer Corp. | 06/12/1996SE |
| K951877 | Automated Analysis Assay for Bilirubin in UrineKQO · Traditional | Chimera Research & Chemical, Inc. | 05/14/1996SE |
| K954158 | STC Diagnostics Auto-Lyte PH AssayKQO · Traditional | Solarcare Technologies Corp,Inc. | 04/30/1996SE |
| K960054 | 900UDX Urine Pathology SystemKQO · Traditional | Intl. Remote Imaging Systems | 03/22/1996SE |
| K954024 | Chemstrip Criterion Urine AnalyzerKQO · Traditional | Boehringer Mannheim Corp. | 10/23/1995SE |
| K946183 | Clinitek Atlas Automated Urine Chemistry AnalyzerKQO · Traditional | Heraeus Kulzer, Inc. | 02/22/1995SE |
| K943592 | Chemstrip Mini Ua Urine AnalyzerKQO · Traditional | Boehringer Mannheim Corp. | 11/08/1994SE |
| K943463 | The Yellow IrisKQO · Traditional | Intl. Remote Imaging Systems | 09/20/1994SE |
| K935408 | Ua PerfectKQO · Traditional | Chimera Research & Chemical, Inc. | 06/13/1994SE |
| K934042 | Chemstrip Super Ua Urine AnalyzerKQO · Traditional | Boehringer Mannheim Corp. | 10/14/1993SE |
| K932674 | Clinitek Atlas Automated Urine Chemistry SystemKQO · Traditional | Miles Inc., Dental Products | 08/19/1993SE |
| K931602 | Chemstrip Urine AnalyzerKQO · Traditional | Boehringer Mannheim Corp. | 06/15/1993SE |
| K926359 | Clinitek 200+ Urine Chemistry AnalyzerKQO · Traditional | Heraeus Kulzer, Inc. | 01/28/1993SE |
| K921087 | Chemstrip Urine AnalyzerKQO · Traditional | Boehringer Mannheim Corp. | 03/24/1992SE |
| K870526 | Super Urine Analyzer SystemKQO · Traditional | Kyoto Daiichi Kagaku Co., Ltd. | 03/06/1987SE |
| K841041 | Clini-Tek Auto 2000 Reflectance SpectrKQO · Traditional | Miles Laboratories, Inc. | 08/24/1984SE |
| K842237 | Clinitek 200 Semi-Automated UrinalysisKQO · Traditional | Miles Laboratories, Inc. | 08/15/1984SE |
| K842238 | Clinitek 10 Semi-Auto Urinalysis SysKQO · Traditional | Miles Laboratories, Inc. | 07/25/1984SE |
| K840996 | Urine Analyzer SystemKQO · Traditional | Kyoto Diagnostics, Inc. | 05/01/1984SE |
| K830220 | Yellow Iris TMKQO · Traditional | Intl. Remote Imaging Systems | 06/17/1983SE |
| K821738 | Clini-Tek Semi-Automated Urinalysis SystKQO · Traditional | Miles Laboratories, Inc. | 07/06/1982SE |
| K813056 | Automated Urinalysis SystemKQO · Traditional | Kyoto Daiichi Kagaku Co., Ltd. | 05/05/1982SE |
| K761306 | Clinilab Automated Urinalysis SystemKQO · Traditional | Miles Laboratories, Inc. | 03/21/1977SE |
| K760472 | Instrumented System for UrinalysisKQO · Traditional | Miles Laboratories, Inc. | 10/29/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1599-2023 Class II | UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysisBeckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had… | Beckman Coulter, Inc. | 04/05/2023Open, Classified |
| Z-1598-2023 Class II | DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic…Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had… | Beckman Coulter, Inc. | 04/05/2023Open, Classified |
| Z-1597-2023 Class II | DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnostic…Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had… | Beckman Coulter, Inc. | 04/05/2023Open, Classified |
| Z-1596-2023 Class II | iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and…Beckman Coulter has become aware of an intermittent issue in which the optional flag Previous Sample Had… | Beckman Coulter, Inc. | 04/05/2023Open, Classified |
| Z-0266-2022 Class II | Cobas u 601 urinalysis test system, Catalog number 06334601001 The cobas U 601…A potential risk for false negative nitrite results exists when endogenous creatinine levels are 15,000 mg/L… | Roche Diagnostics Operations, Inc. | 10/18/2021Terminated |
| Z-1945-2020 Class II | iQ200 Series Urine Microscopy Analyzer- All part numbersA defect in the SATA power adapter cable within the instrument s computer has the potential risk for an… | Beckman Coulter Inc. | 03/30/2020Terminated |
| Z-1944-2020 Class II | iChemVELOCITY Urine Chemistry System-A defect in the SATA power adapter cable within the instruments computer has the potential risk for an… | Beckman Coulter Inc. | 03/30/2020Terminated |
| Z-1535-2020 Class II | iChemVELOCITY Strips, Catalog 800-7212The Leukocyte and Compensation pads were switched on some vials of lot number 7212269M of the iChem VELOCITY… | Beckman Coulter, Inc. | 02/17/2020Terminated |
| Z-1717-2020 Class II | Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either…When excessive amounts of urine spills on the rack transport track and reaches the electrical components of… | Sysmex America, Inc. | 01/21/2020Terminated |
| Z-0843-2020 Class II | iChem VELOCITY Urine Chemistry AnalyzerBeckman Coulter has become aware of an issue affecting Specific Gravity chemistry settings for the… | Beckman Coulter Inc. | 11/07/2019Terminated |
| Z-0913-2020 Class II | iChemVELOCITY, Urine Chemistry System, Catalog numbers: 700-7176-001, 700-7177-001…Customers have reported incidents where two sets of results report the same Specimen Identifier (Specimen… | Beckman Coulter Inc. | 10/28/2019Terminated |
| Z-1850-2019 Class II | AUTION HYBRID AU-4050This correction is being initiated due to a software issue which results in the possibility of incorrect… | Arkray Factory USA, Inc. | 05/03/2019Terminated |
| Z-1937-2019 Class II | iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. The firm name…Falsely elevated (false positive) urobilinogen patient results due to an increase in the sensitivity of the… | Beckman Coulter Inc. | 10/18/2018Terminated |
| Z-1894-2018 Class II | iChem VELOCITY Automated Urine Chemistry System, Catalog #700-7176-001 and iChem…The Strip Provider Modules (SPM) on some of the instruments had not been inspected during manufacture for… | Beckman Coulter Inc. | 03/29/2018Terminated |
| Z-1643-2018 Class II | BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-3530…Beckman Coulter has determined that there is a potential for incorrect settings to be installed on North… | Beckman Coulter Inc. | 03/02/2018Terminated |
| Z-1362-2018 Class II | BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer, Catalog Numbers: 700-3345…Beckman Coulter has determined that there is a potential for under-reporting casts. This can occur if per… | Beckman Coulter Inc. | 03/02/2018Terminated |
| Z-1366-2018 Class II | iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100, Catalog #s:…iQ200 Series Urine Microscopy Analyzer may intermittently fail to read urine sample dilution barcode labels… | Beckman Coulter Inc. | 11/10/2017Terminated |
| Z-1384-2017 Class II | iChemVELOCITY Urine Chemistry System, Catalog No. 800-3530, 800-7167, 800-7719…The probe misalignment or bending has the potential to lead to delay in reporting results or incorrect… | Beckman Coulter Inc. | 01/30/2017Terminated |
| Z-1067-2016 Class II | iChem VELOCITY Automated Urine Chemistry, Catalog No. 800-3049, 800-3050, 800-3079…Iris International noted loose or missing analyte pads found in several locations (strip vial, strip… | Beckman Coulter Inc. | 01/13/2016Terminated |
| Z-2441-2015 Class II | iChemVELOCITY Automated Urine Chemistry Catalog No. 800-3049, 800-3050, 800-3079…Iris International is recalling the iChemVELOCITY systems because they do not maintain the on-board strip… | Iris Diagnostics | 07/15/2015Terminated |
| Z-0086-2014 Class II | HemoCue Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, Sweden The…HemoCue AB has become aware of a production related problem involving punctured HemoCue Urine Albumin… | HemoCue AB | 07/16/2013Terminated |
| Z-1545-2014 Class III | CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.Device with Sample Interference Notes (SIN) enabled not cleared for US marketing. | Siemens Healthcare Diagnostics Inc | 02/26/2013Terminated |
| Z-0512-2012 | Urine Reagent Strips (URS) 11 Parameters URS-11-100G-001 510(K) number: K970250 Devise…This recall was initiated in response to findings during a FDA inspection of the firm. The firm's recall has… | Teco Diagnostics | 10/14/2011Terminated |
| Z-0511-2012 | Urine Reagent Strips (URS) 10 Parameters URS-l0-100W 510(K) number: K970250 Devise…This recall was initiated in response to findings during a FDA inspection of the firm. The firm's recall has… | Teco Diagnostics | 10/14/2011Terminated |
| Z-0583-2011 | NDC, Inc. Pro Advantage Urine Analyzer, Catalog Number: Pro Advantage Urine Analyzer The…This recall has been initiated due to the CLIA-101 Urine Analyzer not having 510(k) clearance by the FDA for… | Teco Diagnostics | 10/01/2010Terminated |
| Z-0582-2011 | McKesson Medical Surgical 107-101 Urine Analyzer, Catalog Number: 107-101 The Uritek…This recall has been initiated due to the CLIA-101 Urine Analyzer not having 510(k) clearance by the FDA for… | Teco Diagnostics | 10/01/2010Terminated |
| Z-0581-2011 | Immunostics, Inc. Detector UriStrip Urine Analyzer, Catalog Number: Detector UriStrip…This recall has been initiated due to the CLIA-101 Urine Analyzer not having 510(k) clearance by the FDA for… | Teco Diagnostics | 10/01/2010Terminated |
| Z-0580-2011 | Henry Schein, Inc. OneStep Pro Urine Analyzer, Catalog Number: OneStep Pro Urine…This recall has been initiated due to the CLIA-101 Urine Analyzer not having 510(k) clearance by the FDA for… | Teco Diagnostics | 10/01/2010Terminated |
| Z-0579-2011 | Cole Taylor Marketing, Inc. CT-101 Urine Analyzer, Catalog Number: CT-101 The Uritek…This recall has been initiated due to the CLIA-101 Urine Analyzer not having 510(k) clearance by the FDA for… | Teco Diagnostics | 10/01/2010Terminated |
| Z-0578-2011 | Cliawaived, Inc. CLIA-101 Urine Analyzer, Catalog Number: CLIA-101 The Uritek TC-101…This recall has been initiated due to the CLIA-101 Urine Analyzer not having 510(k) clearance by the FDA for… | Teco Diagnostics | 10/01/2010Terminated |
| Z-0577-2011 | Teco Diagnostics Uritek TC-101 Urine Analyzer, Catalog Number: TC-101 The Uritek TC-101…This recall has been initiated due to the CLIA-101 Urine Analyzer not having 510(k) clearance by the FDA for… | Teco Diagnostics | 10/01/2010Terminated |