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For in vitro diagnostic use in the quantitative determination of salicylate in human serum and plasma (lithium heparin) on the ADVIA 1650 Chemistry systems. Such measurements are used in the diagnosis of salicylate toxicity and overdose

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I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. The document is an FDA 510(k) clearance letter for the "ADVIA Chemistry Salicylate Reagent" and primarily discusses regulatory compliance and indications for use. No clinical study data or performance metrics are present in the provided pages.

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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 Diagnostic Chemicals Limited's Salicylate method is an in vitro diagnostic device intended to measure salicylate levels in human serum or plasma (Lithium heparin). intended to modellio balleyfato to the diagnosis of salicylate toxicity and overdose.

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The provided text is a 510(k) clearance letter for a Salicylate test system. This type of document does not typically contain the detailed information requested regarding acceptance criteria, study design, or ground truth establishment relevant to AI/ML device performance.

The letter confirms that the device, Salicylate, Cat.Nos.511-20 and 511-40, is substantially equivalent to legally marketed predicate devices for measuring salicylate levels in human serum or plasma to aid in the diagnosis of salicylate toxicity and overdose.

Therefore, I cannot provide the requested information based on the input text. The information is pertaining to a traditional in vitro diagnostic device, not an AI/ML device which would involve specific performance metrics and validation studies against a ground truth as outlined in your request.

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The Bayer ADVIA IMS Salicylate method is an in vitro diagnostic device intended to measure salicylate levels in human serum or plasma (Lithium heparin). Such measurements are used in the diagnosis of salicylate toxicity and overdose.

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Here's a breakdown of the acceptance criteria and study details for the Salicylate method for ADVIA® IMS™, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to demonstrating "equivalence" to the predicate device, the Abbott/TDx Salicylate assay. The reported device performance is compared against the predicate in terms of correlation and imprecision.

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

• Test Set Sample Sizes:
  • Correlation (Serum vs. Abbott/TDx): N = 47
  • Correlation (Plasma vs. Serum): N = 49
  • Imprecision and Interfering Substances: Specific sample size for these tests is not explicitly stated as 'N' values for individual runs but implies multiple measurements for statistical evaluation.
• Data Provenance: Not explicitly stated. It is common for these types of studies to be conducted internally by the manufacturer or a contract research organization. Given it's a diagnostic assay, the samples would likely be human serum and plasma. The country of origin and whether it's retrospective or prospective are not detailed.

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

This type of diagnostic assay, measuring specific analyte concentrations, does not typically involve human experts for establishing ground truth in the same way an image analysis algorithm would. The "ground truth" for the test set is established by:

• Reference Method Measurement: The Abbott/TDx Salicylate assay serves as the comparator (predicate device), and its measurements are used as the reference for correlation.
• Known Concentrations: For imprecision and interfering substances, samples are likely spiked with known concentrations of salicylate and/or interfering substances.

Therefore, the concept of "experts" and their qualifications as described for image analysis is not fully applicable here.

4. Adjudication Method for the Test Set

Not applicable. As explained above, the ground truth is based on quantitative measurements from a reference method or known concentrations, not subjective expert judgment requiring adjudication.

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 standalone in-vitro diagnostic method for measuring a chemical analyte, not an AI-assisted diagnostic tool that aids human readers in interpreting complex data (like medical images).

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

Yes, this study represents a standalone performance evaluation. The ADVIA IMS Salicylate method is an automated assay that provides a quantitative measurement of salicylate levels. Its performance is assessed independently against a predicate device and established analytical criteria, without a human "reading" the final output beyond interpreting the numerical result.

7. The Type of Ground Truth Used

The ground truth used is primarily:

• Reference Method Comparability: Measurements from the legally marketed predicate device (Abbott/TDx Salicylate) serve as the comparative ground truth for evaluating correlation.
• Known Concentrations: For imprecision and interference studies, samples are likely prepared with precisely known concentrations of salicylate and interfering substances.

8. The Sample Size for the Training Set

Not applicable. This is a chemical assay, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The method relies on established chemical reaction principles and calibration curves rather than learning from a large dataset.

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

Not applicable, as there is no "training set" in the context of an AI/ML algorithm. The assay's analytical performance (linearity, sensitivity, specificity) is based on its chemical design and optimization, which would involve internal development and validation using various control materials and known concentrations to establish calibration and performance characteristics.

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Salicylate (SALY) Reagent, when used in conjunction with SYNCHRON® Systems Salicylate Calibrator, is intended for the quantitative determination of salicylate in serum and plasma on Beckman Coulter's SYNCHRON Systems by a colorimetric timed-endpoint method. Measurements obtained by this device are used in diagnosis and treatment of salicylate overdose and in monitoring salicylate levels to ensure appropriate therapy.

The SYNCHRON System Salicylate (SALY) Reagent is designed for optimal performance on the SYNCHRON CX and LX Systems. The assay is intended for use in the quantitative determination of salicylate concentration in serum or plasma by a colorimetric timed-endpoint method. The reagent kit contains two 45-test cartridges and is packaged with the single-level calibrator.

The document provided is a 510(k) summary for the SYNCHRON® Systems Salicylate Reagent, an in vitro diagnostic device used for quantitative determination of salicylate concentration in serum or plasma. It is not an AI/ML device, and therefore, many of the requested criteria (like sample size for test/training set, expert ground truth, adjudication methods, MRMC studies, standalone performance for AI, etc.) are not applicable.

However, based on the information available in the document, here's a description related to its performance validation:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance in terms of Method Comparison and Imprecision. While explicit acceptance criteria (e.g., "slope must be between X and Y") are not detailed as such, the results presented demonstrate performance compared to a predicate device and show reproducibility.

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

• Sample Size (Method Comparison): 75 serum patient specimens.
• Data Provenance: The specimens were "serum patient specimens." The country of origin is not specified, but the submission is from Beckman Coulter in Brea, CA, suggesting US-based data is likely. The study appears to be retrospective, using existing patient specimens.

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

• Not applicable. This is an in vitro diagnostic (IVD) device, not an AI/ML device that requires human expert review for image interpretation or similar. The "gold standard" or "ground truth" for the method comparison is the predicate device, the Abbott TDx Salicylate Assay. For imprecision, the ground truth is statistical reliability based on repeat measurements of control samples.

4. Adjudication Method for the Test Set:

• Not applicable. This concept relates to reconciling discrepancies between human readers or between AI and human readers, which is not relevant for an IVD device measuring analyte concentrations.

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. MRMC studies are for AI/ML devices involving human readers. This device is an automated reagent system.

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

• Yes, in spirit. The performance data presented (Method Comparison and Imprecision) are for the SYNCHRON® Systems Salicylate Reagent and system stand-alone, meaning its performance is evaluated based on its own measurements compared to a predicate or its own reproducibility, independent of human interpretive intervention. The device's output is a quantitative value, not an interpretation requiring human review. User input for sample loading and initiating tests is implied, but the core measurement and result generation are automated.

7. The type of ground truth used:

• For Method Comparison: A legally marketed predicate device (Abbott TDx Salicylate Assay) was used as the comparative "ground truth" to establish substantial equivalence.
• For Imprecision: Statistical measures of variability (Standard Deviation and % Coefficient of Variation) across repeated measurements of control samples served as the basis for assessing precision.

8. The sample size for the training set:

• Not applicable. This device is a reagent for a colorimetric timed-endpoint method, not an AI/ML algorithm that requires a training set. Its development would involve chemical and analytical optimization, not machine learning training.

9. How the ground truth for the training set was established:

• Not applicable. As stated above, there is no AI/ML training set for this type of IVD device.

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The Emit® tox™ Salicylic Acid Assay is a homogenous enzyme immunoassay intended for use in the quantitative analysis of salicylic acid in human serum or plasma. Measurements obtained from this device are used in the diagnosis and treatment of salicylic acid overdose or in monitoring levels of salicylic acid to ensure appropriate therapy.

The Emit® tox™ Salicylic Acid Assay is a homogenous enzyme assay intended for use in quantitative analysis of Salicylic Acid in human serum or plasma.

The Emit® tox™ Salicylic Acid Assay is intended for the quantitative analysis of salicylic acid in human serum or plasma to diagnose and treat salicylic acid overdose or monitor therapeutic levels.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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The Paramax® Salicylate Reagent is intended for use as quantitative determination of salicylate in plasma and serum.

The Paramax® Salicylate Reagent is based on colormetric methodology.

{
  "acceptance_criteria_and_performance": {
    "table": [
      {
        "criterion": "Correlation with predicate device",
        "acceptance_level": "High correlation coefficient",
        "reported_performance": "Correlation coefficient = 0.999"
      },
      {
        "criterion": "Regression equation",
        "acceptance_level": "Regression equation indicating substantial equivalence",
        "reported_performance": "Paramax® value = (1.16 x aca value) - 1.8 mg/dL"
      }
    ],
    "study_summary": "The study demonstrated substantial equivalence between the Paramax® Salicylate Reagent and the DuPont aca Salicylate Reagent based on the high correlation coefficient (0.999) and a regression equation of Paramax® value = (1.16 x aca value) - 1.8 mg/dL."
  },
  "sample_size_test_set": 49,
  "data_provenance": "Not specified (likely clinical samples, but country/retrospective/prospective not mentioned in snippet).",
  "number_of_experts_ground_truth": "Not applicable; the ground truth for this comparison study was established by the predicate device (DuPont aca Salicylate Reagent).",
  "qualifications_of_experts": "Not applicable",
  "adjudication_method": "Not applicable",
  "mrmc_comparative_effectiveness_study": "No, this was a device-to-device correlation study, not an MRMC study involving human readers.",
  "standalone_performance_study": "Yes, the study evaluated the standalone performance of the Paramax® Salicylate Reagent by comparing its results to a predicate device's results on the same samples.",
  "type_of_ground_truth": "Predicate device's results (DuPont aca Salicylate Reagent). The predicate device's measurements are considered the reference for establishing substantial equivalence.",
  "sample_size_training_set": "Not applicable; this is a device validation study, not a machine learning model training.",
  "how_ground_truth_for_training_set_established": "Not applicable"
}

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