# K103612: Dimension Visa Enz 2 Cal

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Jan 25, 2011 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
Longest line of descent: 2 generations back to K860021 (1986). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061390: Dimension Vista System ENZYME2 Calibrator, Model KC320, Dade Behring, Inc. (2006) Summary page 1.

## Most influential descendants
- K153365: ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator (2015), 0 descendants of its own

## Recalls of this device
- May 5, 2016 · Class III · Z-1216-2017: Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the Dimension Vista Enzyme 2 calibrator. Internal investigation has confirmed that patient samples and QC 

## Indications for use
The ENZ 2 CAL is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALT and ALTI) and Aspartate Aminotransferase (AST) on the Dimension Vista® System.

Source page: https://510kreport.com/device/K103612
Methodology: https://510kreport.com/methodology