# K062236: Dimension Vista Cyclosporine (Csa) Flex Reagent Cartridge

- Pathway: 510(k) (Special)
- Applicant: Dade Behring, Inc.
- Decided: Aug 21, 2006 after 19 days
- Product code: MKW (Cyclosporine)
- Device class: 2
- Regulation: 21 CFR 862.1235
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to P890025 (1989). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023065: Cyclosporine (Csa) Flex Reagent Cartridge, Dade Behring, Inc. (2002) Summary page 1.

## Recalls of this device
- Mar 19, 2014 · Class II · Z-1647-2014: 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 t
- Dec 5, 2013 · Class II · Z-0818-2014: Complaints were received regarding variability in recovery of QC and patient results with certain lots of the Dimension Vista CSA Flex reagent cartridges.

## Indications for use
The Dimension VistaTM Cyclosporine (CSA) Flex® reagent cartridge is an in vitro device intended to quantitatively determine cyclosporine concentrations in human whole blood. Measurements of CSA are used as an aid in the management of heart, liver, and kidney transplant patients receiving therapy with this drug.

Source page: https://510kreport.com/device/K062236
Methodology: https://510kreport.com/methodology