(27 days)
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.
| Acceptance Criterion | Reported Device Performance (Summary) |
|---|---|
| Substantial Equivalence to Predicate Device | "Comparative testing described in the protocol included in this submission demonstrates substantially equivalent performance." |
| Same Intended Use and Indications for Use | Confirmed; the packaging modification does not affect intended use or indications. |
| Same Reagents and Fundamental Scientific Technology | Confirmed; reagents are the same, and the fundamental scientific technology is unaltered. |
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.
§ 862.3030 Acetaminophen test system.
(a)
Identification. An acetaminophen test system is a device intended to measure acetaminophen, an analgestic and fever reducing drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose.(b)
Classification. Class II.