MKW · Cyclosporine
Clinical Chemistry · 21 CFR 862.1235 · Class 2
Overview
| Product Code | MKW |
|---|---|
| Device Name | Cyclosporine |
| Regulation | 21 CFR 862.1235 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A cyclosporine test system is a device intended to quantitatively determine cyclosporine concentrations as an aid in the management of transplant patients receiving therapy with this drug. This generic type of device includes immunoassays and chromatographic assays for cyclosporine.
Classification Rationale
Class II (special controls). The special control is “Class II Special Controls Guidance Document: Cyclosporine and Tacrolimus Assays; Guidance for Industry and FDA.” See § 862.1(d) for the availability of this guidance document.
Special Controls
*Classification.* Class II (special controls). The special control is “Class II Special Controls Guidance Document: Cyclosporine and Tacrolimus Assays; Guidance for Industry and FDA.” See § 862.1(d) for the availability of this guidance document.
Recent Cleared Devices (10 of 10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K080751 | ARCHITECT CYCLOSPORINE | Fujirebio Diagnostics,Inc. | Sep 11, 2008 | SESE |
| K071455 | ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR | Siemens Medical Solutions Diagnostics | Sep 11, 2008 | SESE |
| K081992 | DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108 | Siemens Healthcare Diagnostics, Inc. | Aug 5, 2008 | SESE |
| K062236 | DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | Aug 21, 2006 | SESE |
| K053061 | EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY | Dade Behring, Inc. | Feb 6, 2006 | SESE |
| K052017 | CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108 | Dade Behring, Inc. | Sep 1, 2005 | SESE |
| K040761 | AXSYM CYCLOSPORINE | Abbott Laboratories, Inc. | Apr 30, 2004 | SESE |
| K023208 | CEDIA CYCLOSPORINE PLUS ASSAY | Microgenics Corp. | Oct 24, 2002 | SESE |
| K023065 | CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | Oct 16, 2002 | SESE |
| P920031 | EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY | Dade Behring, Inc. | Oct 2, 1996 | APRL |
Top Applicants
- Dade Behring, Inc. — 5 clearances
- Abbott Laboratories, Inc. — 1 clearance
- Fujirebio Diagnostics,Inc. — 1 clearance
- Microgenics Corp. — 1 clearance
- Siemens Healthcare Diagnostics, Inc. — 1 clearance
