# K051087: Dimension Vista Integrated System

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jul 11, 2005 after 74 days
- Product code: JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2160
- Recalls of this device: 32 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K922273 (1992). 13 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944093: Dimension (R) XL Clinical Chemistry System, E.I. Dupont DE Nemours & Co., Inc. (1994) Summary page 2.
- K860021: Dimension (TM) Clinical Chemistry System, E.I. Dupont DE Nemours & Co., Inc. (1986) Summary page 2.
- K990551: Igg Flex Reagent Cartridge, Dade Behring, Inc. (1999) Summary page 2.
- K012470: Modification to N Protein Standard SL, Dade Behring, Inc. (2001) Summary page 2.
- K012468: Modification to N/T Protein Control SL, Dade Behring, Inc. (2001) Summary page 2.
- K944932: Phenobarbital Flex Reagent Cartridge, Dupont Medical Products (1994) Summary page 2.
- K011035: Dimension Drug Calibrator, Model DC22B, Dade Behring, Inc. (2001) Summary page 2.
- K970343: MMB Method, Dade Chemistry Systems, Inc. (1997) Summary page 2.
- K970336: MMB Calibrator, Dade Chemistry Systems, Inc. (1997) Summary page 2.
- K970330: Dade Indirect Imt System with TCO2 Electrode, Dade Intl., Inc. (1997) Summary page 2.

## Most influential descendants
- K073561: Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator (2008), 1 descendant of its own
- K061838: Dimension Vista Chemistry 1 Calibrator, Model KC110 (2006), 1 descendant of its own
- K143720: Dimension Vista MMB Assay (2015), 0 descendants of its own
- K140790: Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG) (2015), 0 descendants of its own
- K081161: Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, and Dimension Vista Syst (2008), 0 descendants of its own

## Recalls of this device
- Oct 15, 2021 · Class II · Z-0330-2022: Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays
- Oct 15, 2021 · Class II · Z-0331-2022: Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays
- Dec 12, 2018 · Class II · Z-1014-2019: When the Millipore Water Purification Module Progard Pretreatment Packs are used with Dimension Vista Triglyceride assay, patient and QC triglyceride results may be erroneously elevated as a result of
- Oct 16, 2018 · Class II · Z-0616-2019: Siemens Healthcare Diagnostics has identified an issue with Dimension Vista software v.3.7 and v.3.8.1 that may result in aliquot well contamination. If a test is cancelled by the operator while the i
- Mar 3, 2017 · Class II · Z-1703-2017: Siemens Healthcare Diagnostics has confirmed that in isolated cases when ECREA is processed immediately after the weekly automated Acid Clean routine during Probe Test, there is the remote potential f
- Mar 24, 2016 · Class II · Z-1885-2016: Discrepant patient results on Dimension Vista Intelligent Lab Systems. Siemens Healthcare confirmed a software defect which, in a very specific set of circumstances, results in the Dimension Vista Sys
- Mar 24, 2016 · Class II · Z-1886-2016: Discrepant patient results on Dimension Vista Intelligent Lab Systems. Siemens Healthcare confirmed a software defect which, in a very specific set of circumstances, results in the Dimension Vista Sys
- Feb 16, 2016 · Class II · Z-1622-2016: Siemens Healthcare Diagnostics has determined that Dimension Vista Blood Urea Nitrogen (BUN) lots 15215AE, 15243BB, 15264BA, 15299BB, 15300BA and 15341AC may exhibit inaccurate patient and/or Quality 
- May 21, 2015 · Class II · Z-2054-2015: Two software issues may occur in Vista software version 3.6.1. Issue #1: Samples may stop processing without notification. Issue #2: Timing issue in Vista 1500 may cause wrong reagent or no reagent de
- Nov 5, 2014 · Class II · Z-0838-2015: Customer complaints of discrepant flagged and/or un-flagged patient and QC results. Reagent probe performance may decline more quickly than anticipated and have an effect on assays with similar formul
- Aug 28, 2014 · Class II · Z-0024-2015: Siemens Healthcare Diagnostics has determined that Dimension Vista® Mass CKMB Isoenzyme Calibrator (MMB CAL) shows drift during routine stability monitoring that exceeds our acceptance criteria for dr
- Apr 14, 2014 · Class II · Z-1733-2014: A small number of Vista Air Compressors were miswired, which if installed and powered up, could cause a fire, or become an electrical shock hazard.
- Oct 7, 2013 · Class II · Z-0851-2014: When utilizing the Routine Inventory screen to enter a User Defined Method (EMPTY) Flex the system may assign the User Defined Method Flex to a different Flex that is currently in inventory on the sys
- Jun 19, 2013 · Class II · Z-2088-2013: Siemens is conducting a field correction for Dimension Vista 500 and Dimension Vista 1500 systems using software versions 3.5.1 and 3.6. Under specific rare conditions which require a system reset, th
- May 20, 2013 · Class II · Z-0430-2014: There is the potential for the vial volume of "in use" Vista calibrators, controls, or sample diluent to incorrectly revert to full volume when removed and reloaded. Dimension Vista(R) 500 and Dimensi
- Jan 16, 2012 · Not classified · Z-1454-2012: Siemens has confirmed customer complaints on Vista(R) software version 3.4 for Below Manufacturer Assay Range error flags associated with QC and patient test results that are within the assay range as
- Oct 31, 2011 · Not classified · Z-0644-2012: Firm has confirmed that specific lots of V-LYTE(R) Fluids may contribute to reduced V-LYTE(R) Integrated Multisensor on-board use life as demonstrated by increases in: Urine sodium QC results within 4
- Oct 31, 2011 · Not classified · Z-0645-2012: Firm has confirmed that specific lots of V-LYTE(R) Fluids may contribute to reduced V-LYTE(R) Integrated Multisensor on-board use life as demonstrated by increases in: Urine sodium QC results within 4
- Oct 31, 2011 · Not classified · Z-0646-2012: Firm has confirmed that specific lots of V-LYTE(R) Fluids may contribute to reduced V-LYTE(R) Integrated Multisensor on-board use life as demonstrated by increases in: Urine sodium QC results within 4
- Aug 8, 2011 · Not classified · Z-0031-2012: Siemens Healthcare Diagnostics has confirmed a low frequency defect in the molding of the Cuvettes that may result in Cuvette Ring and Cuvette Loader jams. It has been determined that the issue is rel
- Aug 19, 2010 · Not classified · Z-0139-2011: High potassium content in the affected lots results in the potential for low potassium recovery for Dilution Check, QC and patient samples when run on the Dimension Vista System.
- Jul 23, 2010 · Not classified · Z-0121-2011: the EasyLink QCFIRST custom rule does not operate as intended.
- May 5, 2010 · Not classified · Z-2423-2010: Defective batteries used in the Alpha Pinnacle P10 UPS External Battery Pack may overheat and cause a strong sulfuric odor to be released and a corrosive sulfuric acid solution leak to occur.
- Mar 15, 2010 · Not classified · Z-2117-2010: Vessel pick up errors and vessel jams when the vessel is being loaded. The error halts the instrument and disrupts processing. Vessel flange is thin.
- Nov 24, 2009 · Not classified · Z-0980-2010: Some vessels may leak. If leakage occurs, patient results will be flagged and are not reportable.
- Oct 22, 2009 · Not classified · Z-1037-2010: Results can elevate after sensor replacement. Sodium urine results can be falsely elevated 15 mmol/L within 24 hours after installation of a new sensor.
- Oct 22, 2009 · Not classified · Z-1038-2010: Results can elevate after sensor replacement. Sodium urine results can be falsely elevated 15 mmol/L within 24 hours after installation of a new sensor.
- Oct 22, 2009 · Not classified · Z-1039-2010: Results can elevate after sensor replacement. Sodium urine results can be falsely elevated 15 mmol/L within 24 hours after installation of a new sensor.
- Sep 1, 2009 · Not classified · Z-1205-2010: Incorrect result: An intermittent low result may be seen with the last test run from an aliquot on a Dimension Vista System when connected to a StreamLAB Analytical Workcell. The sample delivery seque
- Jul 14, 2009 · Not classified · Z-1991-2009: incorrect results may be transmitted to LIS
- Jun 16, 2009 · Not classified · Z-1017-2010: Incorrect result: patient sample BUN results reported may be higher or lower than actual level.
- Jul 3, 2007 · Not classified · Z-1174-2007: Sample ID and Patient results could be associated with the wrong patient

## Indications for use
The Dade Behring Dimension Vista™ Integrated system is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Vista™ system chemical and immunochemical applications utilize photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion selective multisensor technology for clinical use. The Dimension Vista™ Urea Nitrogen Flex® reagent cartridge (BUN) is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases. The Dimension Vista™ Chem I Calibrator is intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of urea nitrogen in human specimens. The Dimension Vista™ Immunoglobulin G Flex® reagent cartridge (IGG) is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulin G (serum antibody) in serum and plasma. Measurement of immunoglobulin G aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. The Dimension Vista™ Protein I Calibrator is intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of IgG in human specimens. The Dimension Vista™ Protein I Controls, H, M, L, are intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. The Dimension Vista™ Phenobarbital Flex® reagent cartridge (PHNO) is a device intended to measure phenobarbital, an antiepileptic and sedative-hypnotic drug, in human serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital to ensure appropriate therapy. Dimension Vista™ Drug I Calibrator is intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of phenobarbital in human specimens. The Dimension Vista™ Mass creatine kinase MB isoenzyme Flex® reagent cartridge (MMB) is a device intended to measure the activity of the MB isoenzyme of creatine phosphokinase in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction. The Dimension Vista™ MMB Calibrator is intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of mass creatine kinase MB isoenzyme in human specimens. The Dimension Vista™ V-LYTE™ Sodium test system is intended to measure sodium in serum, plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. The Dimension Vista™ V-LYTE™ Potassium test system is intended to measure potassium in serum, plasma and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases characterized by low or high blood potassium levels. The Dimension Vista™ V-LYTE™ Chloride test system is intended to measure chloride in serum, plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of electrolyte and metabolic disorders. The Dimension Vista™ V-LYTE™ Standard A and Standard B are intended for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.

Source page: https://510kreport.com/device/K051087
Methodology: https://510kreport.com/methodology