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

The HAIC assay used on the Dimension Vista™ integrated system is an in-vitro diagnostic assay for the quantitative determination of percent hemoglobin A1c(HbA1c) in anticoagulated whole blood. Measurements of percent hemoglobin A1c are effective in monitoring long term glucose control in individuals with diabetes mellitus.

The AMPH Flex® reagent cartridge used on the Dimension Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative determination of amphetamines in human urine using a cutoff of either 300, 500, or 1000 ng/mL. Measurements obtained with the AMPH method are used in the diagnosis and treatment of amphetamines use or overdose. The AMPH method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The BARB Flex® reagent cartridge used on the Dimension Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative determination of barbiturates in human urine. Measurements obtained with the BARB method are used in the diagnosis and treatment of barbiturates use or overdose. The BARB method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The BENZ Flex® reagent cartridge used on the Dimension Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative determination of benzodiazepines in human urine. Measurements obtained with the BENZ method are used in the diagnosis and treatment of benzodiazepines use or overdose. The BENZ method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The COC Flex® reagent cartridge used on the Dimension Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative determination of benzoylecgonine (cocaine metabolite) in human urine using a cutoff of 150 or 300 ng/mL. Measurements obtained with the COC method are used in the diagnosis and treatment of cocaine use or overdose. The COC method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The EXTC Flex® reagent cartridge used on the Dimension Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative determination of methylenedioxymethamine (MDMA), and closely related drugs in human urine using a cutoff of either 300 or 500 ng/mL. Measurements obtained with the EXTC method are used in the diagnosis and treatment of ecstasy use or overdose. The EXTC method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The METH Flex® reagent cartridge used on the Dimension Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative determination of methadone in human urine. Measurements obtained with the METH method are used to detect methadone use or overdose and to determine compliance with methadone maintenance treatment. The METH method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The OPI Flex® reagent cartridge (300 ng/mL cutoff) used on the Dimension Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semi-quantitative determination of opiates in human urine. Measurements obtained with the OPI method are used in the diagnosis and treatment of opiates use or overdose. The OPI method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The PCP Flex® reagent cartridge used on the Dimension Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative determination of phencyclidine in human urine. Measurements obtained with the PCP method are used in the diagnosis and treatment of phencyclidine use or overdose. The PCP method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The THC Flex® reagent cartridge used on the Dimension Vista™ integrated system provides reagents for an in-vitro diagnostic test intended for the qualitative and semiquantitative determination of cannabinoids in human urine. Measurements obtained with the THC method are used in the diagnosis and treatment of cannabinoids use or overdose. The THC method provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other chemical confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Dade Behring Dimension Vista™ Flex® reagent cartridges and the HA1C kit are prepackaged Dade Behring products that are specifically designed to be used on the Dade 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 (K051087). 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 calibrator included in the Dimension Vista™ HAIC kit is the same product (unchanged) as that used in the Dimension® HA1C Kit. The packaging modification, does not affect the intended use of the devices. nor does it alter the fundamental scientific technology of the devices.

Please find the requested information regarding the acceptance criteria and study details below.

1. Table of Acceptance Criteria and the Reported Device Performance

The provided document describes a 510(k) submission for new reagent cartridges and a kit for the Dimension Vista™ system, which are essentially packaging modifications of existing, previously cleared devices for use on a new analyzer system. The core scientific technology and reagents remain the same.

The document mainly focuses on demonstrating substantial equivalence to predicate devices rather than establishing new performance criteria. Therefore, the "acceptance criteria" are implied to be performance comparable to the predicate devices, and the "reported device performance" is framed in terms of achieving this equivalence.

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

The document states, "Comparative testing described in the protocol included in this submission demonstrates substantially equivalent performance." However, it does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for these comparative tests.

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

This information is not provided in the document. As this is an in-vitro diagnostic device for quantitative and qualitative measurements, the "ground truth" would likely be established through reference methods (e.g., GC/MS for drug screens, or an established method for CKMB and HbA1c) rather than expert consensus on images or clinical cases.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not provided in the document. Given the nature of these in-vitro diagnostic tests, adjudication methods like 2+1 or 3+1, which are common in image interpretation or clinical expert review, are not applicable. Instead, the performance would be compared against a reference method or predicate device.

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

No MRMC comparative effectiveness study was done, nor is it applicable to this submission. The device involves in-vitro diagnostic reagent cartridges for automated analyzer systems, not an AI-assisted interpretation or diagnostic tool for human readers.

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

Yes, this describes a standalone performance evaluation in the context of an in-vitro diagnostic device. The Dimension Vista™ system is described as a "floor model, fully automated, microprocessor-controlled, integrated instrument system." The reagents are designed for use on this automated system. The comparative testing would confirm the analytical performance of the reagents on the new system, without human interpretation of the raw data beyond standard laboratory procedures.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the drug screens (Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Ecstasy, Methadone, Opiates, Phencyclidine, Cannabinoids), the "Indications For Use" sections explicitly state: "A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method." This indicates that GC/MS is the ground truth or gold standard against which the screening tests are compared.

For Creatine Kinase MB Isoenzyme (CKMB) and Hemoglobin A1c (HA1C), while not explicitly stated as GC/MS, the "ground truth" would be established by comparison to accepted reference methods or the performance of the predicate devices themselves, as the submission aims to demonstrate substantial equivalence to these existing methods.

8. The Sample Size for the Training Set

The document is a 510(k) submission for modifications to existing products for use on a new instrument system. It focuses on comparative testing to establish substantial equivalence. It does not describe a "training set" in the context of machine learning or algorithm development. The reagents and their fundamental scientific technology are stated to be unchanged from previously cleared devices.

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

As noted in point 8, there is no mention of a "training set" in the context of algorithm development or machine learning in this document. The device's underlying technology is based on established biochemical assays, not a learnable algorithm requiring a training set.

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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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