# K081992: Dimension Vista Csae Flex Regent Cartridge, Model K4108

- Pathway: 510(k) (Special)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Aug 5, 2008 after 22 days
- Product code: MKW (Cyclosporine)
- Device class: 2
- Regulation: 21 CFR 862.1235
- Recalls of this device: none
- 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)
- K052017: Cyclosporine Extended Range Assay (Csae) Flex Reagent Cartridge, Catalog # DF108, Dade Behring, Inc. (2005) Summary page 1.

## Indications for use
The CSAE method is an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista® system. Measurements of CSA are used as an aid in the management of heart, liver and kidney transplant patients.

Source page: https://510kreport.com/device/K081992
Methodology: https://510kreport.com/methodology