# K082030: Dimension Vista Csae Calibrator, Model KC440

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Aug 22, 2008 after 36 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: 4 generations back to K011112 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061503: Dimension Cyclosporine Extended Range Calibrator (DC108A), Dade Behring, Inc. (2006) Summary page 1.

## Indications for use
The CSAE CAL is an in vitro diagnostic product for the calibration of CSAE method on the Dimension Vista® system.

Source page: https://510kreport.com/device/K082030
Methodology: https://510kreport.com/methodology