# K062034: Dimension Vista System Drug 1 Calibrator (Drug 1 Cal - KC410)

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Sep 6, 2006 after 49 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- Device class: 2
- Regulation: 21 CFR 862.1150
- 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 K011035 (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)
- K011035: Dimension Drug Calibrator, Model DC22B, Dade Behring, Inc. (2001) Summary page 2.

## Indications for use
The DRUG I CAL is an in vitro diagnostic product for the calibration of Digoxin (DIG), Lithium (LI), Phenobarbital (PHNO), Phenytoin (PTN) and Theophylline (THEO) methods on the Dimension Vista TM System.

Source page: https://510kreport.com/device/K062034
Methodology: https://510kreport.com/methodology