Electrode, Ion-Specific, Chloride
FDA product code CGZ · Class II (moderate risk) · 21 CFR 862.1170 · Clinical Chemistry
38510(k) clearances
0PMA approvals
9recalls
Manufacturers
- Wallac OY 4
- Hichem Diagnostics 3
- Ortho-Clinical Diagnostics 3
- Abbott Laboratories 3
- Olympus Corp. 2
- Phoenix Diagnostics, Inc. 2
- Medica Corp. 2
- Alko Diagnostic Corp. 2
- Nova Biomedical Corp. 2
- Ciba Corning Diagnostics Corp. 1
- Nova Corp. 1
- Boehringer Mannheim Corp. 1
- Data Medical Associates, Inc. 1
- Synermed, Inc. 1
- Sendx Medical Inc 1
- Instrumentation Laboratory CO 1
- Diametrics Medical, Inc. 1
- A.P. Total Care, Inc. 1
- Em Diagnostic Systems, Inc. 1
- Wescor, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K182072 | VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS…CGZ · Traditional | Ortho-Clinical Diagnostics, Inc. | 10/30/2018SE |
| K170320 | Alinity c ICT Sample DiluentCGZ · Traditional | Abbott Laboratories | 10/24/2017SE |
| K162020 | VITROS Chemistry Products Cl- SlidesCGZ · Traditional | Ortho Clinical Diagnostics | 12/16/2016SE |
| K082099 | Vitros Chemistry Products Ci-Dt Slides; Vitros Chemistry Products DT Calibrator Kit…CGZ · Special | Ortho-Clinical Diagnostics, Inc. | 08/21/2008SE |
| K070889 | Autodelfia Neonatal Irt L Kit, Model B022-112CGZ · Traditional | Wallac OY | 04/14/2008SE |
| K070531 | Ise Module and Bar Code Reader Addition for the Datapro Clinical Chemistry AnalyzerCGZ · Traditional | Thermo Fisher Scientific | 09/04/2007SE |
| K060108 | Cobas Integra Chloride Elctrode GEN.2CGZ · Special | Roche Diagnostics Corp. | 02/16/2006SE |
| K052027 | Opti Lion Electrolyte Analyzer, Model GD7200CGZ · Traditional | Osmetech, Inc. | 09/29/2005SE |
| K020148 | pHoenix ISE Reagents FOR Olympus AU Chemistry SystemsCGZ · Traditional | Phoenix Diagnostics, Inc. | 02/04/2002SE |
| K013451 | Phoenoix Ise Reagents for Roche Hitachi, Models 700/900 SeriesCGZ · Traditional | Phoenix Diagnostics, Inc. | 12/18/2001SE |
| K003664 | Delfia Neonatal Irt Kit, Model A005-110CGZ · Traditional | Wallac OY | 02/14/2001SE |
| K003668 | Autodelfia Neonatal Irt Kit, Model B005-112CGZ · Traditional | Wallac OY | 02/12/2001SE |
| K993697 | Delfia Neonatal Irt KitCGZ · Traditional | Wallac OY | 06/09/2000SE |
| K000926 | Easyelectrolyte Analyzer and Rapidlyte AnalyzerCGZ · Traditional | Medica Corp. | 05/15/2000SE |
| K991870 | Electrolytes (Na+, K+, Cl-), Product No's 114-01, 114-02, 114-03CGZ · Traditional | A.P. Total Care, Inc. | 07/30/1999SE |
| K981270 | Irma Blood Analysis SystemCGZ · Traditional | Diametrics Medical, Inc. | 05/01/1998SE |
| K980757 | Ilab 600 Clinical Chemistry SystemCGZ · Traditional | Instrumentation Laboratory CO | 04/21/1998SE |
| K980367 | Aeroset SystemCGZ · Traditional | Abbott Laboratories | 04/01/1998SE |
| K973742 | Sendx 100 PH, Blood Gas and Electrolyte Analysis SystemCGZ · Traditional | Sendx Medical, Inc. | 12/03/1997SE |
| K972004 | Ise Reagents for Olympus Au 800/AU5200 Chemistry SystemsCGZ · Traditional | Alko Diagnostic Corp. | 06/16/1997SE |
| K962479 | Synermed Ise ReagentsCGZ · Traditional | Synermed, Inc. | 03/03/1997SE |
| K963992 | Capillary Adaptor AccessoryCGZ · Traditional | Medica Corp. | 11/29/1996SE |
| K963734 | Ise Reagents for Hitachi 700 Series and 911 Clinical Chemistry SystemsCGZ · Traditional | Alko Diagnostic Corp. | 10/24/1996SE |
| K953862 | Hichem Isekci Solution Kit 70010CGZ · Traditional | Hichem Diagnostics | 09/06/1995SE |
| K953861 | Hichem Ise Intdernal Reference Kit 70009CGZ · Traditional | Hichem Diagnostics | 09/06/1995SE |
| K953860 | Hichem Ise Diluent Kit 70008CGZ · Traditional | Hichem Diagnostics | 09/06/1995SE |
| K935228 | Model 644 Sweat DiluentCGZ · Traditional | Ciba Corning Diagnostics Corp. | 08/01/1994SE |
| K924864 | Nova 13 Analyzer, ModificationCGZ · Traditional | Nova Biomedical Corp. | 11/06/1992SE |
| K912561 | Nova 13 AnalyzerCGZ · Traditional | Nova Biomedical Corp. | 09/11/1991SE |
| K912647 | Ise/Ci-CGZ · Traditional | Boehringer Mannheim Corp. | 07/17/1991SE |
| K900887 | Abbott Spectrum Automated Clinical Chem. AnalyzerCGZ · Traditional | Abbott Laboratories | 05/15/1990SE |
| K893628 | Olympus Ise Module for AU5000CGZ · Traditional | Olympus Corp. | 08/11/1989SE |
| K885193 | Olympus Ise ModuleCGZ · Traditional | Olympus Corp. | 02/03/1989SE |
| K863395 | Wescor Sweat.Chek Sweat Conductivity AnalyzerCGZ · Traditional | Wescor, Inc. | 05/24/1988SE |
| K861669 | Sodium, Potassium and Chloride ProcedureCGZ · Traditional | Data Medical Associates, Inc. | 05/27/1986SE |
| K860668 | Ion-Specific Electrode, ChlorideCGZ · Traditional | Em Diagnostic Systems, Inc. | 04/07/1986SE |
| K844021 | Ise Reagents for Demand AnalyzerCGZ · Traditional | Advanced Biomedical Methods, Inc. | 12/10/1984SE |
| K790653 | Nova 3 Chloride/Total Dioxide AnalyzerCGZ · Traditional | Nova Corp. | 06/15/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0268-2020 Class II | VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine…Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen… | Ortho-Clinical Diagnostics | 09/10/2019Terminated |
| Z-0267-2020 Class II | VITROS chemistry Products Cl- Slides, Catalog No. 6844471 (which supports Urine CL-).…Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen… | Ortho-Clinical Diagnostics | 09/10/2019Terminated |
| Z-1296-2019 Class II | Abbott ARCHITECT cSystems ICT Module, REF 09D28-03. Product Usage: The ARCHITECT…There is a potential to generate falsely elevated serum or plasma chloride results when using the product. | Abbott Laboratories, Inc | 08/28/2018Terminated |
| Z-3184-2018 Class III | VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage: VITROS Cl…The slides failed to meet current claims for Limit of Blank (LoB), Limit of Detection (LoD) and Limit of… | Ortho-Clinical Diagnostics | 07/11/2018Terminated |
| Z-3043-2018 Class III | VITROS Chemistry Products Cl- Slides, Product Code 844 5207 Product Usage: For in vitro…The slides do not meet the maximum allowable interference (MAI) claims for triglyceride interference when… | Ortho-Clinical Diagnostics | 07/11/2018Terminated |
| Z-2558-2011 | OPTI LION E-Plus Cassette, Model BP7507, Opti Medical (25 Cassettes with Samples Probes…The values reported by the chloride sensors may report erroneous values below specification on aqueous… | OPTI Medical Systems, Inc | 03/15/2011Terminated |
| Z-1083-2010 | OPTI LION Cassettes, E-Plus, Model BP7507 (25 per box), OSME TECH critical care.…Outer box labeling shows an incorrect storage temperature range. | OPTI Medical Systems, Inc | 04/20/2009Terminated |
| Z-2231-2008 | ARCHITECT c8000 Processing Module, for in vitro diagnostics; List Number 1G06-01 and…Software defect can allow tests ordered for one sample to be aspirated from a different sample, reporting… | Abbott Laboratories, Inc | 05/23/2008Terminated |
| Z-1166-2008 | Clinical Chemistry ICT Calibrator, List Number: 1E46-02, Abbott Labs, Abbott Park, IL…Quality Control (Out of Range)- ICT Calibrator lot number: 0505017, may contain an interferent. Not all… | Abbott Laboratories, Inc | 09/26/2007Terminated |