# K052017: Cyclosporine Extended Range Assay (Csae) Flex Reagent Cartridge, Catalog # DF108

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Sep 1, 2005 after 37 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: 1 generation back to P890025 (1989). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P890025: TD Cyclosporine and Metabolites Serum Assay, Abbott Laboratories (1989) Summary page 2.

## Most influential descendants
- K081992: Dimension Vista Csae Flex Regent Cartridge, Model K4108 (2008), 0 descendants of its own

## Indications for use
The CSAE Flex® reagent cartridge is an in vitro diagnostic test intended to quantitatively measure cyclosporine A (CSA) in human whole blood for the Dimension® clinical chemistry 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/K052017
Methodology: https://510kreport.com/methodology