# K103836: Enzyme II Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Feb 16, 2011 after 48 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: 2 (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.
No later device cites it as a predicate yet.
0 of 3 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.

## Recalls of this device
- Feb 23, 2017 · Class III · Z-1712-2017: Siemens Healthcare Diagnostics has confirmed a positive bias of up to 41% in quality control and patient results for Aspartate Aminotransferase (AST) and Aspartate Aminotransferase concentrated (AST_c
- May 5, 2016 · Class III · Z-1217-2017: Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the Dimension Enzyme II calibrator. Internal investigation has confirmed that patient samples and QC mater

## Indications for use
The Enzyme 11Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALTI) on the Dimension® clinical chemistry system.

Source page: https://510kreport.com/device/K103836
Methodology: https://510kreport.com/methodology