# K140790: Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Jun 15, 2015 after 441 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- 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: 5 generations back to K891093 (1989). 39 ancestors in all.
No later device cites it as a predicate yet.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061838: Dimension Vista Chemistry 1 Calibrator, Model KC110, Dade Behring, Inc. (2006) Summary page 5.
- K061655: Dimension Vista Flex Reagent Cartridges, Dade Behring, Inc. (2006) Summary page 5.
- K981743: Olympus AU400 Clinical Chemistry Analyzer, Olympus America, Inc. (1998) Summary page 10.

## Recalls of this device
- Nov 12, 2024 · Class II · Z-0767-2025: Siemens Healthcare Diagnostics is recalling two lots of their Dimension Vista Total Magnesium (MG) Flex Reagent Cartridges (lots 24057BB and 24064BC) due to the potential for falsely low measurements 
- Jan 28, 2022 · Class II · Z-0830-2022: Dimension Vista Magnesium Flex reagent cartridge lots exhibiting imprecision and intermittent Abnormal Assay flags. When this issue occurs, there is a potential for QC failures or erroneous patient re

## Indications for use
The Dimension Vista® Magnesium Flex® reagent cartridge (MG) method is an in vitro diagnostic test for the quantitative measurement of magnesium in human serum, plasma and urine on the Dimension Vista® System. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium). The Dimension Vista® Chemistry 1 Calibrator (CHEM 1 CAL) is an in vitro diagnostic product for the calibration of Blood Urea Nitrogen (BUN),Calcium (CA), Cholesterol (CHOL), Creatinine (CRENCRE2), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyronine Uptake (TU) and Uric Acid (URCA) methods on the Dimension Vista® System.

Source page: https://510kreport.com/device/K140790
Methodology: https://510kreport.com/methodology