# K061390: Dimension Vista System ENZYME2 Calibrator, Model KC320

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jul 5, 2006 after 48 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 K860021 (1986). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K860021: Dimension (TM) Clinical Chemistry System, E.I. Dupont DE Nemours & Co., Inc. (1986) Summary page 2.

## Most influential descendants
- K103612: Dimension Visa Enz 2 Cal (2011), 1 descendant of its own
- K153365: ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator (2015), 0 descendants of its own
- K103836: Enzyme II Calibrator (2011), 0 descendants of its own

## Indications for use
The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) on the Dimension VistaTM System.

Source page: https://510kreport.com/device/K061390
Methodology: https://510kreport.com/methodology