# K061838: Dimension Vista Chemistry 1 Calibrator, Model KC110 - Pathway: 510(k) (Traditional) - Applicant: Dade Behring, Inc. - Decided: Aug 21, 2006 after 53 days - Product code: JIX (Calibrator, Multi-Analyte Mixture) - Device class: 2 - Regulation: 21 CFR 862.1150 - Recalls of this device: 3 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 3 generations back to K922273 (1992). 14 ancestors in all. 1 later device descends from it; 1 cites it directly. 0 of 16 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K051087: Dimension Vista Integrated System, Dade Behring, Inc. (2005) Summary page 1. ## Most influential descendants - K140790: Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG) (2015), 0 descendants of its own ## Recalls of this device - Sep 15, 2016 · Class II · Z-0652-2017: Siemens determined that discrepant low calcium recovery of QC and patient samples can occur with Dimension Vista CHEM 1 CAL lots 5GM081 and 5GM082. - Aug 18, 2014 · Class II · Z-2720-2014: Siemens Healthcare Diagnostics has received complaints for low recovery of Magnesium (MG) Quality Control (QC) and patient samples following calibration of MG with the Dimension Vista® CHEM 1 CAL, - Aug 31, 2009 · Not classified · Z-0864-2010: Siemens Healthcare Diagnostics, Inc. has confirmed high accuracy shifts with Dimension Vista URCA Flex reagent cartridge (various lots) when calibrating with some vials from CHEM 1 calibrator lot 9DM0 ## Indications for use The CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyronine Uptake (TU), Blood Urea Nitrogen (BUN), and Uric Acid (URCA) methods on the Dimension VistaT M System Source page: https://510kreport.com/device/K061838 Methodology: https://510kreport.com/methodology