EMIT 2000 Cyclosporine Specific Assay
by Dade Behring, Inc. 510(k)PMA
Active
PMA P920031510(k) K053061
Overview
The EMIT 2000 Cyclosporine Specific Assay is an in vitro diagnostic immunoassay device classified as a Cyclosporine assay under the Clinical Chemistry nomenclature. It is designed for the quantitative measurement of cyclosporine (CSA) in human whole blood, aiding in the monitoring and management of immunosuppressive therapy in kidney, heart, and liver transplant patients.
This assay is intended for use exclusively on Roche Diagnostics’ COBAS MIRA, COBAS MIRA S, and COBAS MIRA Plus Chemistry Systems. Supplied as a single-use reagent kit, the device requires no sterilisation beyond manufacturer-provided packaging. It has received FDA Approval (PMA P920031) and FDA 510(k) clearance (K053061) under the Traditional and Substantially Equivalent pathways, respectively, and is regulated under FDA classification II (device code MKW). Storage conditions and shelf-life are specified in the accompanying instructions.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK053061 | Date6 Feb 2006 | StatusActive |
| United States | FDA PMA PMA | NumberP920031 | Date2 Oct 1996 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k), FDA PMA Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Generic Name
- CYCLOSPORINE
- PMA Number
- 510(k) Number
- FDA Product Code
- MKW
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1235
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Dade Behring, Inc.
Questions
What specific patient populations is the EMIT 2000 Cyclosporine Specific Assay designed to monitor, and how does it help in their care?
The EMIT 2000 Cyclosporine Specific Assay is designed for quantitative measurement of cyclosporine (CSA) in human whole blood to aid in managing immunosuppressive therapy. It is specifically intended for kidney, heart, and liver transplant patients, helping clinicians monitor CSA levels to optimize dosing, reduce toxicity risks, and improve transplant outcomes by ensuring therapeutic drug levels are maintained.
Which Roche Diagnostics chemistry systems is this assay compatible with, and is it a single-use or reusable device?
The EMIT 2000 Cyclosporine Specific Assay is exclusively compatible with Roche Diagnostics’ **COBAS MIRA, COBAS MIRA S, and COBAS MIRA Plus Chemistry Systems**. It is supplied as a **single-use reagent kit**, meaning each kit is intended for one use only and does not require sterilization beyond the manufacturer-provided packaging.
How should the EMIT 2000 Cyclosporine Specific Assay be stored, and what is its shelf life?
Storage conditions and shelf life for the EMIT 2000 Cyclosporine Specific Assay are detailed in the accompanying instructions provided by the manufacturer. Since the device is a single-use reagent kit, proper storage is critical to maintaining accuracy and reliability. Always refer to the included documentation for precise guidelines.
What regulatory pathways does this device follow, and what does that mean for its use in clinical settings?
The EMIT 2000 Cyclosporine Specific Assay has received **FDA Approval (PMA P920031)** under the **Premarket Approval (PMA)** pathway and **FDA 510(k) clearance (K053061)** under the **Substantially Equivalent (Traditional)** pathway. This means the device has undergone rigorous review to ensure safety, effectiveness, and compliance with FDA standards for in vitro diagnostic use. Clinicians can rely on its regulatory clearance for clinical chemistry applications, particularly for monitoring cyclosporine levels in transplant patients.