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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 Urea Nitrogen Flex® reagent cartridge (BUN) is intended for the quantitative measurement of urea nitrogen (an end product of urea nitrogen metabolism) in human serum, plasma, and urine on the Dimension VistaTM system. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.

The Immunoglobulin G Flex® reagent cartridge (IGG) is intended for the quantitative measurement of immuoglobulin G (IgG) in human serum and plasma on the Dimension Vista™ system. Measurement of immunoglobulin G is used in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

The Phenobarbital Flex® reagent cartridge (PHNO) is intended for the quantitative measurement of phenobarbital in human serum and plasma on the Dimension Vista™ system. 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.

The Mass creatine kinase MB isoenzyme Flex® reagent cartridge (MMB) is intended for the quantitative measurement of mass creatine kinase MB isoenzyme in human serum and plasma on the Dimension Vista™ system for the confirmation of acute myocardial infarction. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction.

The V-L YTE™ Integrated Multisensor is intended for the quantitative measurement of sodium, potassium, and chloride in human serum, plasma, and urine on the Dimension Vista™ system. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (large dilute urine, accompanies deficient, inappropriate antidiuretic hormone secretion), or other causes of electrolyte imbalance. Measurements obtained by this device are used in the diagnosis and treatment of diseases conditions, characterized by low or high blood levels. Measurements obtained by this device are used in the diagnosis and treatment of renal and metabolic disorders.

The Chemistry I calibrator is intended for the calibration of the Urea Nitrogen (BUN) method on the Dimension Vista™ system. 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 Protein 1 calibrator is intended for the calibration of the Immunoglobulin G (IGG) method on the Dimension Vista™ system. 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 Protein 1 controls, H, M. & L are intended for use as an assayed intralaboratory quality control for assessment of precision and analytical bias in the determination of Immunoglobulin G (IGG) results on the Dimension Vista™ system. The Dimension Vista™ Protein I Controls, H. M, L, are intended for medical purposes for use in a test system to estimate method or analytical instrument variation.

The Drug 1 calibrator is intended for the calibration of the Phenobarbital (PHNO) method on the Dimension Vista™ system. 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 measurement of phenobarbital in human specimens.

The Mass CKMB Isoenzyme calibrator is intended for the calibration of the creatine kinase MB isoenzyme (MMB) method on the Dimension Vista™ system. 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 V-LYTE™ Standard A & B are intended for the calibration of the Na'/K /Cl methods on the Dimension Vista™ system. The Dimension Vista™ V-LYTE I™ Standard & and Standard B are intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in human specimens.

The Dade Bchring Dimension Vista™ Integrated system is a floor model, fully automated, microprocessor-controlled, integrated instrument system that uses prepackaged Dade Behring Flex® reagent test cartridges to measure a variety of analytes in human body fluids. The system is a multifunctional analytical tool that processes chemical and immunochemical methodologies, utilizing photometric, turbidimetric, chemiluminesence, nephelometric, and integrated ion selective multisensor detection technologies for clinical use. The Vista™ system includes a communications and connectivity workstation (Easy Link™) for interaction with laboratory information system (L1S) networks, monitoring the usage of the system to suggest preventive maintenance, and QC result management.

This document is a 510(k) summary for the Dade Behring Dimension Vista™ Integrated system and its associated reagents, calibrators, and controls. The submission aims to establish substantial equivalence to existing predicate devices.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied to be "equivalent performance and design" compared to the predicate devices. This equivalence is demonstrated by a method comparison study, where the performance of the Dimension Vista™ system is compared to the predicate Dimension® Analyzer. The reported performance is presented in terms of slope, intercept, and correlation coefficient (r) from linear regression analysis.

2. Sample Size Used for the Test Set and Data Provenance

The sample sizes for the test set vary by analyte and sample type:

• BUN: 111 (Serum/Plasma), 75 (Urine)
• IGG: 98 (Serum/Plasma)
• PHNO: 75 (Serum/Plasma)
• MMB: 136 (Serum/Plasma)
• V-LYTE™ Na+: 103 (Serum/Plasma), 52 (Urine)
• V-LYTE™ K+: 103 (Serum/Plasma), 52 (Urine)
• V-LYTE™ Cl-: 104 (Serum/Plasma), 51 (Urine)

The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given the nature of a 510(k) submission for an in vitro diagnostic device, it is typically expected that such studies are conducted prospectively using clinical laboratory samples, but this is not explicitly stated.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. For in vitro diagnostic devices like the Dimension Vista™ system, the "ground truth" for method comparison studies is typically established by the predicate device's results. Therefore, there wouldn't be external "experts" establishing ground truth in the same way as an image-based diagnostic study. The predicate device itself acts as the reference standard.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Given that the study is a method comparison between two automated analyzers, there is no need for expert adjudication of results. Both devices provide quantitative measurements, and the comparison is statistical.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable and therefore not provided. The Dimension Vista™ system is an automated in vitro diagnostic analyzer, not an AI-assisted diagnostic tool that aids human readers in image interpretation or diagnosis. Therefore, MRMC studies and "human reader improvement with AI" are not relevant to this device's evaluation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This document describes the performance of an automated in vitro diagnostic system which, by its nature, functions in a "standalone" or "algorithm-only" manner once samples are loaded and analysis is initiated. The "performance" presented (slope, intercept, correlation coefficient) reflects the inherent analytical capability of the device, independent of human interpretation or intervention in the measurement process itself.

7. The Type of Ground Truth Used

The ground truth for this method comparison study is the results obtained from the predicate device (Dimension® RxL Analyzer and its associated Flex® reagent cartridges). This is a common and accepted method for demonstrating substantial equivalence for new in vitro diagnostic devices.

8. The Sample Size for the Training Set

The document does not provide information on a separate "training set" or its sample size. For an IVD system like the Dimension Vista™, the development and validation of the analytical methods would involve extensive internal development, calibration, and verification using various samples (e.g., spiked samples, patient samples, controls) over time. The listed sample sizes (e.g., 111 for BUN serum/plasma) represent the clinical test set used for direct comparison to the predicate device to support the 510(k) submission, not a distinct "training set" in the machine learning sense.

9. How the Ground Truth for the Training Set Was Established

Since a "training set" in the context of device development (distinct from the clinical comparison test set) is not explicitly detailed, the method for establishing its ground truth is also not described. However, in general, the "ground truth" for developing and calibrating such a system would involve:

• Using samples with known, quantitatively measured concentrations (e.g., reference materials, certified calibrators).
• Comparing results to established laboratory reference methods or highly accurate methods (e.g., mass spectrometry).
• Ensuring accuracy across the measuring range.

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