# K061750: Dimension Vista System Lipid Calibrator, Model KC220

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Aug 11, 2006 after 51 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
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.

## Indications for use
The LIPID CAL is an in vitro diagnostic product for the calibration of high density lipoprotein cholesterol (HDLC) and low density lipoprotein cholesterol (LDLC) methods on the Dimension VistaTM System.

Source page: https://510kreport.com/device/K061750
Methodology: https://510kreport.com/methodology