Cyclosporine
FDA product code MKW · Class II (moderate risk) · 21 CFR 862.1235 · Clinical Chemistry
9510(k) clearances
1PMA approvals
5recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K080751 | Architect CyclosporineMKW · Traditional | Fujirebio Diagnostics,Inc. | 09/11/2008SE |
| K071455 | Advia Centaur Cyclosporine Assay and CalibratorMKW · Traditional | Siemens Medical Solutions Diagnostics | 09/11/2008SE |
| K081992 | Dimension Vista Csae Flex Regent Cartridge, Model K4108MKW · Special | Siemens Healthcare Diagnostics, Inc. | 08/05/2008SE |
| K062236 | Dimension Vista Cyclosporine (Csa) Flex Reagent CartridgeMKW · Special | Dade Behring, Inc. | 08/21/2006SE |
| K053061 | Emit 2000 Cyclosporine Specific AssayMKW · Traditional | Dade Behring, Inc. | 02/06/2006SE |
| K052017 | Cyclosporine Extended Range Assay (Csae) Flex Reagent Cartridge, Catalog # DF108MKW · Traditional | Dade Behring, Inc. | 09/01/2005SE |
| K040761 | Axsym CyclosporineMKW · Traditional | Abbott Laboratories, Inc. | 04/30/2004SE |
| K023208 | Cedia Cyclosporine Plus AssayMKW · Traditional | Microgenics Corp. | 10/24/2002SE |
| K023065 | Cyclosporine (Csa) Flex Reagent CartridgeMKW · Traditional | Dade Behring, Inc. | 10/16/2002SE |
PMA approvals
- P920031 Emit 2000 Cyclosporine Specific Assay · Dade Behring, Inc. · 10/02/1996
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1687-2018 Class II | ADVIA Centaur CyclosporineThe concentrations for biotin listed in the non-interfering substances section of the instructions for use… | Siemens Healthcare Diagnostics, Inc. | 01/02/2018Terminated |
| Z-1647-2014 Class II | Dimension Vista CSA and CSAE The Cyclosporine method is an in vitro diagnostic test for…A complaint was received of Dimension Vista CSA and CSAE under-recovery of cyclosporine when patient samples… | Siemens Healthcare Diagnostics, Inc. | 03/19/2014Terminated |
| Z-0818-2014 Class II | Dimension Vista Cyclosporine Flex reagent cartridge an in vitro diagnostic test for the…Complaints were received regarding variability in recovery of QC and patient results with certain lots of… | Siemens Healthcare Diagnostics, Inc. | 12/05/2013Terminated |
| Z-0162-2012 | ARCHITECT Cyclosporine; an in-vitro diagnostic chemiluminescent microparticle…The ARCHITECT Cyclosporine assay has the potential to generate falsely elevated or depressed results with… | Abbott Laboratories | 10/07/2011Terminated |
| Z-1998-2011 | Cyclosporine Sample Pretreatment Reagent, COBAS INTEGRA, IVD, Roche Diagnostics GmbH…The cyclosporine sample pretreatment reagent lot was assigned an incorrect expiration date. | Roche Diagnostics Operations, Inc. | 08/13/2010Terminated |