# K061703: Dimension Vista Chemistry 2 Calibrator (Chem 2 Cal, KC120)

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Aug 2, 2006 after 47 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Recalls of this device
- Feb 26, 2010 · Not classified · Z-2387-2010: There is incorrect barcode information, which can potentially cause the Alert Message "Calibrator Insert Missing" to be displayed.

## Indications for use
The CHEM 2 CAL is an in vitro diagnostic product for the calibration of Phosphorus (PHOS), Salicylate (SAL), and Triglycerides (TRIG) methods on the Dimension VistaTM System.

Source page: https://510kreport.com/device/K061703
Methodology: https://510kreport.com/methodology