# K083579: Dimension Vista System Enzyme 6 Calibrator, Model KC360

- Pathway: 510(k) (Abbreviated)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Feb 20, 2009 after 78 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: 2 generations back to K834502 (1984). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081731: Dimension Cki Flex Reagent Cartridge, Dimension Mbi Flex Reagent Cartridge, and Cki/Mbi Calibrator, Models DF38, DF32, Siemens Healthcare Diagnostics (2008) Summary page 1.

## Most influential descendants
- K160724: ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator (2016), 0 descendants of its own

## Indications for use
The ENZ 6 CAL is an in vitro diagnostic product for the calibration of the Creatine Kinase (CKI) and Creatine Kinase MB (MBI) methods on the Dimension Vista® System.

Source page: https://510kreport.com/device/K083579
Methodology: https://510kreport.com/methodology