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The Dimension Vista™ Acetaminophen (ACTM) Flex® reagent cartridge is a device intended to measure acetaminophen, an analgesic and antipyretic (fever reducing) drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose.

The Dimension Vista™ Amylase (AMY) Flex® reagent cartridge is a device intended to measure the activity of the enzyme amylase in serum, plasma and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

The Dimension Vista™ Creatine Kinase (CK) Flex® reagent cartridge is a device intended to measure the activity of the enzyme creatine kinase in serum and plasma. Measurements of creatine kinase are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive Duchenne-type muscular dystrophy.

The Dimension Vista™ Cholesterol (CHOL) Flex® reagent cartridge is a device intended to measure cholesterol in serum and plasma. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

The Dimension Vista™ Gamma-glutamyl transferase (GGT) Flex® reagent cartridge is a device intended to measure gamma-glutamyl transferase in human serum and plasma. Gamma-glutamyl transferase measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors.

The Dimension Vista™ Glucose (GLU) Flex® reagent cartridge is a device intended to measure glucose in human serum, plasma, urine and cerebrospinal fluid. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal and idiopathic hypoglycemia, and pancreatic islet cell carcinoma.

The Dimension Vista™ High-Density Lipoprotein Cholesterol (HDLC) Flex® reagent cartridge is intended to measure high-density lipoprotein cholesterol in serum and plasma. Measurements of high-density lipoprotein cholesterol are used in the diagnosis of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

The Dimension Vista™ Low-Density Lipoprotein Cholesterol (LDLC) Flex® reagent cartridge is intended to measure low-density lipoprotein cholesterol in serum and plasma. Measurements of low-density lipoprotein cholesterol are used in the diagnosis of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

The Dimension Vista™ Lidocaine (LIDO) Flex® reagent cartridge is a device intended to measure lidocaine, an antiarrythmic and anticonvulsant drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of lidocaine overdose or in monitoring levels of lidocaine to ensure appropriate therapy.

The Dimension Vista™ Magnesium (MG) Flex® reagent cartridge is intended for the measurement of magnesium levels in serum and plasma. 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™ Pseudocholinesterase (PCHE) Flex® reagent cartridge is a device intended to measure pseudocholinesterase activity in human serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning).

The Dimension Vista™ Phosphorus (PHOS) Flex® reagent cartridge is a device intended to measure inorganic phosphorus in serum, plasma, and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

The Dimension Vista™ Procainamide (PROC) Flex® reagent cartridge is a device intended to measure procainamide in serum and plasma. Measurements obtained may be used in the diagnosis and treatment of procainamide overdose and in monitoring levels of procainamide to ensure appropriate therapy.

The Dimension Vista™ Salicylate (SAL) Flex® reagent cartridge is a device intended to measure salicylates, a class of analgesic, antipyretic and anti-inflammatory drugs that includes aspirin, in human serum. Measurements obtained by this device are used in the diagnosis and treatment of salicylate overdose and in monitoring salicylate levels to ensure appropriate therapy.

The Dimension Vista™ Thyroxine (T4) Flex® reagent cartridge is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

The Dimension Vista™ Tobramycin (TOBR) Flex® reagent cartridge is a device intended to measure tobramycin, an aminoglycoside antibiotic drug, in palsma and serum. Measurements obtained by this device are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy.

The Dimension Vista™ Triglyceride (TRIG) Flex® reagent cartridge is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.

The Dimension Vista™ Uric Acid (URCA) Flex® reagent cartridge is a device intended to measure uric acid in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.

The Dimension Vista™ Valproic Acid (VALP) Flex® reagent cartridge is a device intended to measure valproic acid, an anti-convulsant drug in serum and plasma. Measurements obtained may be used in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid to ensure appropriate therapy.

The Dimension Vista™ Vancomycin (VANC) Flex® reagent cartridge is a device intended to measure vancomycin, an antibiotic drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.

Dade Behring Dimension Vista™ Flex® reagent cartridges are prepackaged in-vitro diagnostic test methods (assays) that are specifically designed to be used on the Vade Behring Dimension Vista™ Integrated system, a floor model, fully automated, microprocessor-controlled, integrated instrument system. The Dimension Vista™ system was previously cleared with seven associated test methods (K 051087). This Special 510(k) is submitted for a packaging modification to in-vitro diagnostic devices that have been cleared under the 510(k) process for use on Dimension® clinical chemistry systems. The packaging change is to allow use on the Dimension Vista™ system.

The reagents contained in the Dimension Vista™ Flex® reagent cartridges are the same as those contained in the Flex® reagent cartridges manufactured for the Dimension® clinical chemistry systems, another family of Dade Behring analyzers. The packaging modification, does not affect the intended use of the devices, nor does it alter the fundamental scientific technology of the devices.

Here's a breakdown of the acceptance criteria and study information for the Dade Behring Dimension Vista™ Flex® reagent cartridges, based on the provided 510(k) summary:

This device submission is a Special 510(k) for a packaging modification, meaning the core technology and reagents are the same as previously cleared devices. Therefore, the primary goal of the study is to demonstrate substantially equivalent performance after the packaging change, rather than to establish initial performance claims for a novel device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria or specific performance metrics (e.g., accuracy, precision values) for each analyte. Instead, it relies on a comparative equivalency approach to a predicate device.

The overarching acceptance criterion is "substantially equivalent performance" to the predicate Dimension® Flex® reagent cartridges.

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

The document states: "Comparative testing described in the protocol included in this submission demonstrates substantially equivalent performance."

• Sample Size for Test Set: This information is not explicitly stated in the provided summary. The summary refers to a "protocol included in this submission," which would contain these details.
• Data Provenance: This information is not explicitly stated in the provided summary.
• Retrospective or Prospective: This information is not explicitly stated. However, given the nature of in-vitro diagnostic testing for performance comparison, it would typically involve prospective testing on patient samples or spiked samples.

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

This is an in-vitro diagnostic device for quantitative measurement of analytes in human samples (serum, plasma, urine, CSF). The ground truth for such devices is established by:

• Reference Methods: Highly accurate and precise laboratory methods, often gold standards like GC-MS, HPLC, or other well-validated enzymatic or spectrophotometric methods.
• Certified Reference Materials (CRMs): Samples with known, certified concentrations of the analytes.

Therefore, the concept of "experts" in the clinical imaging or diagnostic interpretation sense (e.g., radiologists) is not applicable here. The ground truth is laboratory-based and instrumental.

4. Adjudication Method for the Test Set

Not applicable for this type of in-vitro diagnostic device. Ground truth is established by reference methods or certified materials, not by expert consensus or adjudication.

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

• No, an MRMC comparative effectiveness study was not done.
• This device is an in-vitro diagnostic reagent cartridge, not an AI-powered diagnostic imaging tool or a system designed for human interpretation with or without AI assistance. The performance is measured instrumentally.

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

• Yes, the performance evaluated is inherently "standalone" in the context of an automated analytical instrument. The Flex® reagent cartridges are designed to be used on the Dimension Vista™ Integrated system, a "fully automated, microprocessor-controlled, integrated instrument system." The performance of the reagent (device) is measured by its output on this automated system.
• There is no "human-in-the-loop" decision-making component for the measurement process itself, although clinical interpretation of the results by a healthcare professional is expected.

7. The Type of Ground Truth Used

The ground truth for this type of in-vitro diagnostic device would typically involve:

• Reference Method Assays: Using established, highly accurate, and precise laboratory methods (e.g., a recognized primary reference measurement procedure or a well-characterized predicate device itself) to determine the true concentration of the analytes in the test samples.
• Certified Reference Materials: Commercial or internal standards with known, traceable concentrations of the analytes.
• Sample Matrix: Patient samples (serum, plasma, urine, CSF) with concentrations spanning the analytical range.

The summary states "Comparative testing... demonstrates substantially equivalent performance." This strongly implies that the new device's measurements were compared against the measurements obtained by the predicate device on the same samples, which serves as the "reference" or "ground truth" for the equivalence claim.

8. The Sample Size for the Training Set

This device is a reagent cartridge for an in-vitro diagnostic test, not a machine learning or AI algorithm in the contemporary sense that requires a "training set" to learn. The reagents and their chemical reactions are based on established scientific principles.

Therefore, the concept of a "training set" as understood in machine learning is not applicable to this device.

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

As noted above, the concept of a "training set" is not applicable to this device. The ground truth for the performance evaluation (test set) would be established by reference methods or comparison to the predicate device, as described in point 7.

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The Dade Behring Dimension® Lidocaine (LIDO) Flex® reagent cartridge method on the Dimension® clinical chemistry system is for the quantitative determination of lidocaine in serum or plasma. Lidocaine measurements may be used in the diagnosis and treatment of lidocaine overdose and in therapeutic drug monitoring.

The Dade Behring Dimension® Drug Calibrator II (DC49D) is a device intended for medical purposes for use on the Dimension® clinical chemistry system to establish points of parfonob to are used in determination of values in the measurement of substances in human specimens.

Method: The Dade Behring Dimension® Lidocaine (LIDO) Flex® reagent cartridge method is an in vitro diagnostic test that consists of prepackaged reagents in a flexible plastic cartridge for use only on the Dimension® clinical chemistry system. The Dimension® LIDO Flex® reagent cartridge assay is based on a homogenous particle-enhanced turbition immunoassay (PETINIA) which uses a latex particle-lidocaine conjugate and monoclonal lidocaine specific antibody. Lidocaine present in the sample competes with lidocaine on the particles for available antibody, thereby decreasing the rate of aggregation. Hence, the rate of aggregation is inversely proportional to the concentration of lidocaine in the sample. The rate of aggregation is measured using bichromatic turbidimetric readings at 340 nm and 700 nm.

Calibrator: The Dade Behring Drug Calibrator 11 (DC49D) is liquid, bovine serum base product, packaged as ten vials to a carton, with two vials at each of five levels; each vial contains 5.0 mL. This same product, the Dade Behring Drug Calibrator II (DC49C), was previously cleared (K032574) for calibration of its associated methods on the Dimension® clinical chemistry system. The product remains unchanged except for the additional value assignment for the Lidocaine constituent.

Here's a breakdown of the acceptance criteria and the study details based on the provided text, formatted to address your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on demonstrating substantial equivalence to a predicate device. Therefore, the "acceptance criteria" are implicitly met by showing good agreement with the predicate. The performance is reported as a comparison to this predicate.

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

• Test Set Sample Size: 120 (for the split-sample comparative performance).
• Data Provenance: Not explicitly stated (e.g., country of origin). The data is from a "split-sample comparative performance" study, which by its nature is a prospective comparison of the new device against the predicate on the same samples.

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

Not applicable. This study did not involve establishing a ground truth through expert consensus. Instead, it compared the new device's measurements directly against those of a legally marketed predicate device. The predicate device's measurements served as the comparative standard.

4. Adjudication Method for the Test Set

Not applicable. As the study is a direct comparative measurement against a predicate, there was no need for adjudication by experts.

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

Not applicable. This is a study for an in vitro diagnostic (IVD) device (a laboratory test for measuring a substance in a sample), not an imaging or AI-assisted diagnostic device involving human readers or interpretation of medical cases.

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

Yes, in essence. The "Dimension® Lidocaine (LIDO) Flex® reagent cartridge method" is an automated in vitro diagnostic assay. Its performance (accuracy, precision, linearity, etc.) is evaluated inherently as a standalone system. The study performed here is a "standalone" comparison of its analytical performance against another standalone analytical system (the predicate device). There is no "human-in-the-loop" component for interpretation in the context of this device.

7. The Type of Ground Truth Used

The "ground truth" for the test set was the measurements obtained from the predicate device, the Dade Behring aca® LIDO analytical test pack method (K833379). This is a "comparison to a legally marketed device" or "predicate device comparison" type of ground truth for demonstrating substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This medical device (an in vitro diagnostic assay and calibrator) does not utilize machine learning or AI models, and therefore does not have a "training set" in that context. The development of the reagent cartridge and its parameters would have involved various optimization studies, but these are not referred to as a "training set" in the sense of AI/ML.

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

Not applicable, as there is no "training set" as defined for AI/ML models.

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The Roche ONLINE TDM Lidocaine assay is for the quantitative determination of lidocaine in human serum or plasma on automated clinical chemistry analyzes. Lidocaine is an antiarrhythmic agent administered intravenously by either injection or continuous infusion. It is indicated in the acute management of ventricular arritythmias such as those occurring in relation to acute myocardial infarction, or during cardiac manipulation, such as cardiac surgery. The proposed labeling indicates the Roche/Hitachi 911, 912, 917, and Modular P analyzers can be used with the Roche ONLINE Lidocaine reagent kits.

The assay is a homogeneous immunoassay based on the principle of measuring changes in scattered light or absorbance which result when activated microparticles aggregate. The microparticles are coated with lidocaine and rapidly aggregate in the presence of a lidocaine antibody solution. When a sample containing lidocaine is introduced, the aggregation reaction is partially inhibited, slowing the rate of the aggregation process. Antibody bound to sample drug is no longer available to promote microparticle aggregation, and subsequent particle lattice formulation is inhibited. Thus, a classic inhibition curve with respect to lidocaine concentration is obtained, with the maximum rate of aggregation at the lowest lidocaine concentration. By monitoring the change in scattered light or absorbance, a concentration-dependent curve is obtained.

Acceptance Criteria and Device Performance Study for Roche ONLINE Lidocaine Assay

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details a comparison study between the Roche ONLINE TDM Lidocaine assay and a predicate device (Roche COBAS INTEGRA Lidocaine), as well as a comparison to an FPIA method. The acceptance criteria are implicitly derived from the comparison to these established methods, demonstrating "acceptable results" and "substantial equivalence."

Note: The document states that "All of the evaluation studies gave acceptable results compared to the predicate device," indicating the overall acceptance criteria were met.

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

• Test Set (comparison to predicate device): N = 99
• Test Set (comparison to FPIA method): N = 69
• Data Provenance: Not explicitly stated regarding country of origin or specific demographic details. The studies were conducted by Roche Diagnostics Corporation in Indianapolis, IN, suggesting the data is likely from the United States. The studies are described as "evaluation studies," implying they were specifically conducted for the premarket notification and are thus prospective in nature, as they assess the performance of the new device.

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

This type of in vitro diagnostic device (immunoassay for drug concentration) does not typically rely on "experts" in the same way an imaging or diagnostic AI system would. The "ground truth" for drug concentration in serum or plasma is established by validated analytical methods. In this case, the predicate device (Roche COBAS INTEGRA Lidocaine Assay) and an FPIA method (Fluorescence Polarization Immunoassay, a common method for therapeutic drug monitoring) served as the reference or "ground truth" for comparison. Therefore, no external "experts" were used to establish ground truth in this context; rather, established and validated analytical techniques served this role.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "ground truth" was established by reference analytical methods, not by human interpretation or consensus that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This study is for an in vitro diagnostic assay, which measures a quantitative analyte concentration, not an imaging or interpretive diagnostic task that would typically involve multiple readers.

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

Yes, this study represents the standalone performance of the Roche ONLINE TDM Lidocaine assay. This is an automated immunoassay designed to provide a quantitative result without direct human interpretation of the assay's output for each measurement. Human involvement is limited to sample loading, instrument operation, and result review, but the assay itself generates the lidocaine concentration.

7. The Type of Ground Truth Used

The ground truth used was analytical reference methods:

• The Roche COBAS INTEGRA Lidocaine Assay (the predicate device)
• An FPIA (Fluorescence Polarization Immunoassay) method

These methods are well-established and validated for determining lidocaine concentrations in biological samples.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" for the Roche ONLINE TDM Lidocaine assay in the context of machine learning. As an immunoassay, the device's performance is based on its chemical and optical principles, not on being "trained" on a dataset in the way an AI algorithm would be. The development and optimization of the assay reagents and parameters would have occurred during the assay's R&D phase, but this is distinct from "training a model."

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

Not applicable, as there is no "training set" in the machine learning sense for this immunoassay device. The performance characteristics were evaluated against established analytical reference methods.

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