Dimension Vista Cyclosporine (CSA) Flex Reagent Cartridge

• • Terminated Z-1647-2014 FDA Class II ·initiated 19 Mar 2014

  A complaint was received of Dimension Vista CSA and CSAE under-recovery of cyclosporine when patient samples are run from the Small Sample Container. The under-recovery that has been observed is 18 to 44%. In March 2014, Siemens recalled due to the complaint received of Dimension Vista CSA and CSAE reporting under-recovery of cyclosporine when patient samples are run from the Small Sample C

• • Terminated Z-0818-2014 FDA Class II ·initiated 5 Dec 2013

  Complaints were received regarding variability in recovery of QC and patient results with certain lots of the Dimension Vista CSA Flex reagent cartridges.

510(k) Number

K062236 ↗

FDA Product Code

MKW

Device Class

Class II

Regulation

21 CFR Part 862.1235

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What clinical chemistry analyzer does the Dimension Vista Cyclosporine (CSA) Flex Reagent Cartridge work with, and how is it prepared for use?

  The Dimension Vista Cyclosporine (CSA) Flex Reagent Cartridge is designed exclusively for the Dimension Vista Integrated System, a fully automated clinical chemistry analyzer. It is supplied sterile and pre-packaged, requiring no additional preparation beyond insertion into the system. No further setup or activation is needed before use.

• Is the Dimension Vista Cyclosporine (CSA) Flex Reagent Cartridge intended for single-use or repeated use, and how does this impact its handling?

  The cartridge is explicitly designed for single-use only, as indicated by its classification as a reagent cartridge. This means each cartridge must be discarded after a single analysis to maintain accuracy and prevent cross-contamination. Proper disposal protocols must be followed to ensure compliance with laboratory safety standards.

• What type of samples can the Dimension Vista Cyclosporine (CSA) Flex Reagent Cartridge measure, and why is this important for transplant patients?

  The cartridge quantitatively measures cyclosporine concentrations in human whole blood, which is critical for monitoring immunosuppressive therapy in transplant patients. Accurate cyclosporine levels help clinicians adjust dosing to balance efficacy (preventing rejection) and minimize side effects, ensuring patient safety and treatment success.

• How is the regulatory status of this device described, and what does this mean for healthcare providers?

  The device holds FDA 510(k) clearance (K062236) under the classification of Clinical Chemistry (product code MKW) and is classified as a Class II device (862.1235). This means it has undergone regulatory review to demonstrate substantial equivalence to a predicate device, ensuring it meets established safety and performance standards for diagnostic use in clinical settings.

• Are there any special handling or storage requirements for the Dimension Vista Cyclosporine (CSA) Flex Reagent Cartridge?

  While the device is supplied sterile and pre-packaged, specific storage instructions are not detailed in the provided data. However, as a reagent cartridge for automated systems, it should be stored in a clean, dry environment protected from extreme temperatures and direct light to preserve its integrity until use. Always follow the manufacturer’s (Dade Behring) supplementary guidelines for optimal performance.