Cyclosporine
The Cyclosporine assay is an in vitro diagnostic device used to measure cyclosporine concentrations in patient blood specimens to facilitate therapeutic drug monitoring in transplant patients and those receiving cyclosporine for autoimmune conditions, ensuring drug levels remain within a therapeutic range to prevent organ rejection or toxicity. Classified as a Class 2 device under 21 CFR 862.1235 within the Clinical Chemistry specialty, it requires 510(k) premarket notification. It carries no implant or life-sustaining flags.
Basic Information
- Product Code
- MKW
- Device Class
- FDA class 2
- Regulation Number
- 862.1235
- Medical Specialty
- Clinical Chemistry
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K080751 | ARCHITECT CYCLOSPORINE | Sep 11, 2008 | Substantially Equivalent | Fujirebio Diagnostics,Inc. |
| K071455 | ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR | Sep 11, 2008 | Substantially Equivalent | Siemens Medical Solutions Diagnostics |
| K081992 | DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108 | Aug 05, 2008 | Substantially Equivalent | Siemens Healthcare Diagnostics, Inc. |
| K062236 | DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE | Aug 21, 2006 | Substantially Equivalent | Dade Behring, Inc. |
| K053061 | EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY | Feb 06, 2006 | Substantially Equivalent | Dade Behring, Inc. |
| K052017 | CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108 | Sep 01, 2005 | Substantially Equivalent | Dade Behring, Inc. |
| K040761 | AXSYM CYCLOSPORINE | Apr 30, 2004 | Substantially Equivalent | Abbott Laboratories, Inc. |
| K023208 | CEDIA CYCLOSPORINE PLUS ASSAY | Oct 24, 2002 | Substantially Equivalent | Microgenics Corp. |
| K023065 | CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE | Oct 16, 2002 | Substantially Equivalent | Dade Behring, Inc. |
FEI Numbers
This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.