# K062199: Dimension Vista System Drug 3 Calibrator (Drug 3 Cal - KC430)

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Sep 6, 2006 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: 1 generation back to K011112 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011112: Cyclosporine Calibrator, Dade Behring, Inc. (2001) Summary page 2.

## Indications for use
The DRUG 3 CAL is an in vitro diagnostic product for the calibration of the cyclosporine (CSA) method on the Dimension VistaTM System.

Source page: https://510kreport.com/device/K062199
Methodology: https://510kreport.com/methodology