# K061923: Dimension Vista Enzyme 1 Calibrator (Enz 1 Cal - KC310)

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Aug 25, 2006 after 49 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Dimension Clinical Chemistry System Enzyme 1 Calibrator: named in the summary without a submission number
- (no number) Dimension Clinical Chemistry System Lipase Calibrator: named in the summary without a submission number
- (no number) Dimension Vista System Enzyme 1 Calibrator: named in the summary without a submission number

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

## Recalls of this device
- Jan 6, 2014 · Class II · Z-1076-2014: Complaints were received regarding Quality Control (QC) shifts with Pseudocholinesterase (PCHE) and imprecision during PCHE calibration with the Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL).

## Indications for use
The ENZ 1 CAL is an in vitro diagnostic product for the calibration of Amylase (AMY), Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Lipase (LIP), and Pseudocholinesterase (PCHE) methods on the Dimension VistaTM System.

Source page: https://510kreport.com/device/K061923
Methodology: https://510kreport.com/methodology