# K053108: Dimension Csae Cyclosporine Extended Range Calibrator, Model DC108

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Feb 16, 2006 after 104 days
- Product code: DLJ (Calibrators, Drug Specific)
- Device class: 2
- Regulation: 21 CFR 862.3200
- 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 K011112 (2001). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052015: Dimension Extended Range Cyclosporine Calibrator, Catalog # DC108, Dade Behring, Inc. (2005) Summary page 1.

## Most influential descendants
- K061503: Dimension Cyclosporine Extended Range Calibrator (DC108A) (2006), 1 descendant of its own
- K082030: Dimension Vista Csae Calibrator, Model KC440 (2008), 0 descendants of its own

## Indications for use
The CSAE Calibrator is an in vitro diagnostic product intended to be used to calibrate the Cyclosporine A, Extended Range (CSAE) method for the Dimension® clinical chemistry system or the Syva® Emit® 2000 Cyclosporine Specific Assay.

Source page: https://510kreport.com/device/K053108
Methodology: https://510kreport.com/methodology