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For in vitro diagnostic and laboratory professional use.

VITROS Chemistry Products PHBR Slides quantitatively measure phenobarbital (PHBR) concentration in serum and plasma (lithium heparin) using the automated VITROS 5600 Integrated System.

Measurements obtained by this device are used as an aid in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital to help ensure appropriate therapy.

The VITROS PHBR Slide is a multilayered, analytical element coated on a polyester support. The phenobarbital assay is based on an enzymatic heterogeneous, competitive immunoassay format. Immobilized anti-phenobarbital antibody and phenobarbital-peroxidase conjugate are present in the spreading layer.

A drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. Phenobarbital in the sample competes with the phenobarbitalperoxidase conjugate for a limited number of antibody binding sites during Incubation 1. The subsequent addition of 12 µL of VITROS Immuno-Wash Fluid to the slide removes unbound phenobarbital-peroxidase conjugate from the read area, while also providing a substrate for the enzyme mediated oxidation of leuco dye.

The rate of dye formation, as monitored by reflectance spectrophotometry for Incubation 2, is inversely proportional to the phenobarbital concentration in the sample. To determine if an adequate wash has occurred, a wash detection dye is read at 540 nm during Incubation 2.

Here's an analysis of the provided FDA 510(k) summary, specifically focusing on the acceptance criteria and study proving the device meets those criteria, formatted as requested:

Device: VITROS Chemistry Products PHBR Slides
Device Type: In vitro diagnostic device for quantitative measurement of phenobarbital (PHBR) concentration in serum and plasma.

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary outlines several analytical performance characteristics that serve as acceptance criteria for the VITROS Chemistry Products PHBR Slides. The document doesn't explicitly state "acceptance criteria" for all metrics in the form of numerical thresholds before the study results, but rather presents the study results as meeting acceptable performance for substantial equivalence. For some, like LoQ, a specific goal is mentioned.

Within Lab: PHBR conc. (µg/mL) / SD / %CV
5.0 / 0.25 / 5.0%
9.1 / 0.33 / 3.6%
11.0 / 0.44 / 4.0%
23.0 / 0.65 / 2.8%
25.1 / 0.81 / 3.2%
38.1 / 1.09 / 2.9%
59.3 / 2.11 / 3.6% |
| Detection Limits (LoD) | Demonstrate a limit of detection low enough for clinical utility. No explicit numerical criterion stated prior to reporting. | LoD: 1.3 µg/mL |
| Detection Limits (LoQ) | Allowable error goal for LoQ: ≤ 1.5 µg/mL. | Claimed LoQ: 3.0 µg/mL. The study found the claimed LoQ to be acceptable within the ≤ 1.5 µg/mL total error goal. |
| Linearity | Deviation from linearity within allowable limits: ± 1.3 µg/mL at phenobarbital concentrations 10 µg/mL. | Demonstrated linearity over the measuring range of 3.0 - 80.0 µg/mL. LLLI: 0.5 µg/mL, ULLI: 83.5 µg/mL. Reported deviation from linearity was within the specified allowable deviations. |
| Specificity (Interference) | Bias > 1.8 µg/mL at approx. 15 µg/mL PHBR or bias > 5.2 µg/mL at approx. 50 µg/mL PHBR considered significant interference. Implied acceptance: most common substances should not interfere, or known interferences clearly identified and characterized. | Nine (9) substances showed interference (bias exceeding criteria) at specified concentrations relative to PHBR concentrations of 15 µg/mL or 50 µg/mL. Sixty-one (61) other test substances did not cause significant bias. |
| Cross-Reactivity | Characterize the cross-reactivity of structurally related compounds and common co-prescribed drugs. Implied acceptance: cross-reactivity is understood and characterized. | Cross-reactivity of 12 substances (e.g., amobarbital, mephobarbital, phenytoin) was evaluated. Results are provided for reference in the customer instructions for use (specific numerical results not provided in this summary). |
| Measuring Range | 3.0 – 80.0 µg/mL | 3.0 – 80.0 µg/mL |

2. Sample Sizes and Data Provenance

• Method Comparison: 142 serum samples.
• Precision: 88 observations (2 replicates per run, 2 runs per day over 22 days) using patient pools and quality control materials.
• Linearity: Fourteen proportionally related admixtures of low and high concentration fluids were tested, each in duplicate.
• Specificity (Interference) & Cross-Reactivity: Number of individual samples tested for each interferent/cross-reactant not explicitly stated, but the studies describe adding substances to serum samples.
• Training Set Sample Size: Not applicable based on the provided document. This is an IVD device measuring analyte concentration, not an AI/ML device requiring a training set for algorithm development in the traditional sense. The phrase "training set" is typically used for machine learning models.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective). Standard laboratory validation protocols (CLSI guidelines listed) imply controlled, often prospective, collection for such studies.

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

• Not applicable. The "ground truth" for this device (a quantitative diagnostic for phenobarbital concentration) is established by direct chemical measurement in the form of a reference method (the predicate device) or by known concentrations of prepared standards/controls. It does not involve expert interpretation or consensus in the way a diagnostic imaging AI might.

4. Adjudication Method for the Test Set

• Not applicable. This specific study does not involve human readers or interpretations that would require adjudication. Measurements are quantitative and compared to a reference method or known concentrations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. An MRMC study is typically performed for AI-assisted diagnostic imaging or similar scenarios where human readers make subjective interpretations. This document describes the analytical performance of an in vitro diagnostic device for measuring a chemical analyte, which is not subject to human reader variability in the same way.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Yes, indirectly. The entire document describes the standalone analytical performance of the VITROS Chemistry Products PHBR Slides on the VITROS 5600 Integrated System. The device provides a quantitative measurement directly, without human interpretation in the loop that would alter the result itself. The measurements obtained are then used by laboratory professionals to aid in diagnosis and treatment, but the device's performance itself is evaluated as a standalone analytical instrument.

7. Type of Ground Truth Used

• Reference Method / Known Concentrations:
  • For Method Comparison, the ground truth is established by the results from the legally marketed predicate device (ARCHITECT iPhenobarbital Assay) on the same patient samples.
  • For Precision, Detection Limits, Linearity, Specificity, and Cross-Reactivity, the ground truth is established by using prepared samples with known, controlled concentrations of phenobarbital and/or interfering/cross-reacting substances.

8. Sample Size for the Training Set

• Not applicable. As explained in section 2, this is an IVD device for quantitative measurement, not an AI/ML device that requires a "training set" for algorithm development.

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

• Not applicable. No training set in the AI/ML sense. For analytical validation, ground truth is established by precisely prepared standards and controls, or by comparison to a validated reference method (like the predicate device).

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The Abbott Phenobarbital assay is for in vitro diagnostic use for the quantitative measurement of phenobarbital in human serum or plasma on the ARCHITECT cSystems. The measurements obtained are used in the diagnosis and treatment of phenobarbital overdose and in monitoring levels of phenobarbital to help ensure appropriate therapy.

The Phenobarbital Assay kit is supplied ready-to-use in liquid form, for storage at 2 to 8°C. Each Phenobarbital Assay kit is packaged in a rectangular cardboard box divided into three sections. One section will contain three bottles of Antibody Reagent (R1), one section will contain three bottles of Microparticle Reagent (R2), and the last section will contain the package insert. Each kit is sufficient for 300 tests.

The Abbott Phenobarbital Assay demonstrated substantial equivalence to the predicate device (Abbott Aerosett Phenobarbital Assay (K993031)) through a series of performance studies. The studies assessed various analytical characteristics of the device to ensure it meets its intended use for the quantitative measurement of phenobarbital in human serum or plasma.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Limit of Quantitation (LOQ): The text indicates the LOQ was measured "over an extended period" but does not specify the exact number of samples or runs.
• Precision: Not explicitly stated, but the study followed a CLSI protocol, which typically involves multiple samples tested over several runs and days.
• Spike Recovery: "Negative serum samples were spiked with phenobarbital at concentrations across the assay range." The exact number of samples is not stated.
• Method Comparison: 108 samples (n=108) were tested.
• Matrix Comparison: The following matrices were tested: serum in glass, serum in plastic, serum separator tube (SST) in plastic, plasma with sodium fluoride/potassium oxalate in plastic, plasma with sodium heparin in plastic and glass, plasma with lithium heparin in plastic with or without gel, plasma with K3 EDTA in glass and plastic, plasma with K2 EDTA in plastic, and sodium citrate in plastic and glass. The number of samples for each matrix is not specified.
• Specificity (Cross-Reactivity/Interference): Not explicitly stated, but implies multiple substances were tested across various concentrations.
• Linearity: "Samples were tested to demonstrate linearity throughout the assay range." The exact number of samples is not specified.
• Onboard Stability, Standard Curve Calibration Stability, Reagent Shelf Life Stability: These studies involve testing over time with an unspecified number of samples or replicates.

Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the nature of in vitro diagnostic device testing for regulatory submission, it is typically prospective, controlled laboratory studies using prepared samples (spiked, diluted, or well-characterized patient samples).

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

This type of submission for an in vitro diagnostic assay does not typically involve expert clinical readers or radiologists. The "ground truth" for the test set is established by:

• Reference Methods: For method comparison, High-Performance Liquid Chromatography (HPLC) results are used as the reference method ("gold standard") for phenobarbital concentration. This approach does not involve human expert interpretation in the same way imaging studies might.
• Known Concentrations: For studies like linearity, spike recovery, LOQ, and precision, samples are prepared with known, precisely measured concentrations of phenobarbital.
• CLSI Protocols: The reference to CLSI protocols indicates established laboratory standards are followed for experimental design and data analysis, ensuring the rigor of the "ground truth" establishment through standardized procedures.

Therefore, there are no "experts" in the clinical interpretation sense involved in establishing the ground truth; rather, the ground truth is analytically derived.

4. Adjudication Method for the Test Set

Not applicable. As described above, the ground truth is established through analytical reference methods or known sample compositions, not through human adjudication of clinical findings.

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 device is an in vitro diagnostic assay for quantitative measurement, not an AI-assisted diagnostic imaging or clinical decision support tool that involves human readers.

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

The entire performance evaluation is inherently a "standalone" or "algorithm-only" assessment in the context of an automated IVD assay. The Abbott Phenobarbital Assay, once calibrated, quantifies phenobarbital concentration based on its reaction kinetics. The performance studies detailed are evaluating this standalone analytical performance.

7. The Type of Ground Truth Used

The ground truth used in these studies is primarily:

• Reference Method Assays: For method comparison, HPLC (High-Performance Liquid Chromatography) served as the reference method for confirming phenobarbital concentrations.
• Known Concentrations: For precision, linearity, LOQ, and spike recovery, samples were prepared with known, established concentrations of phenobarbital.

8. The Sample Size for the Training Set

The document describes performance testing for a finished device. It does not provide information about a "training set" in the context of machine learning, as this is a chemical assay, not an AI/ML device. Therefore, the concept of a training set as understood in AI/ML is not applicable here. The assay is "trained" or optimized during its development phase through iterative experimentation, but the data for this is not detailed in a 510(k) summary (which focuses on verification and validation).

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

Not applicable, as there is no "training set" in the AI/ML sense. The "ground truth" for the development and optimization of the assay would have been established through precisely prepared samples with known phenobarbital concentrations and comparisons to established analytical methods during the research and development phases of the assay.

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The ARCHITECT iPhenobarbital assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of phenobarbital, an anticonvulsant and sedative-hypnotic drug, in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The measurements obtained are used in the diagnosis and treatment of phenobarbital overdose and in monitoring levels of phenobarbital to help ensure appropriate therapy.

The ARCHITECT iPhenobarbital Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of phenobarbital in human serum or plasma.

The ARCHITECT i Phenobarbital assay is a one-step STAT immunoassay for the quantitative measurement of phenobarbital in human serum or plasma using CMIA technology, with flexible assay protocols, referred to as Chemiflex. Sample, antiphenobarbital coated paramagnetic microparticles, and phenobarbital acridiniumlabeled conjugate are combined to create a reaction mixture. The anti-phenobarbital coated microparticles bind to phenobarbital present in the sample and to the phenobarbital acridinium-labeled conjugate. After washing, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). An indirect relationship exists between the amount of phenobarbital in the sample and the RLUs detected by the ARCHITECT i System optics.

The provided document describes the ARCHITECT iPhenobarbital assay, which is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of phenobarbital in human serum or plasma.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a dedicated table. Instead, it claims substantial equivalence to a legally marketed predicate device (AxSYM Phenobarbital) based on specific performance characteristics. The key performance metrics evaluated are:

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

The document does not provide specific details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "non-clinical performance data" and "clinical performance."

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This information is not applicable and therefore not provided, as this is an in vitro diagnostic (IVD) device for measuring a chemical analyte (phenobarbital), not an imaging or diagnostic device that relies on expert human image interpretation for ground truth. The "ground truth" for this device would be established by reference methods or comparison to a predicate device.

4. Adjudication Method for the Test Set

This information is not applicable, as adjudication methods are typically used in studies involving human interpretation or subjective assessments, not for quantitative chemical measurements in an IVD device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study was not done. This type of study is specifically relevant for devices where human readers interpret medical images or other complex data. The ARCHITECT iPhenobarbital assay is an automated in vitro diagnostic test for a chemical analyte.

6. Standalone Performance Study

Yes, a standalone study was done. The "Summary of Non-Clinical Performance" and "Summary of Clinical Performance" sections describe the device's performance in terms of precision, linearity, interferences, and clinical correlation with a predicate device. This is the standalone performance of the algorithm/assay itself.

• Non-Clinical Performance: Evaluated precision, linearity, and interferences of the ARCHITECT iPhenobarbital assay.
• Clinical Performance: Compared the ARCHITECT iPhenobarbital assay to the AxSYM Phenobarbital assay, yielding a correlation coefficient of 1.0.

7. Type of Ground Truth Used

The "ground truth" for the ARCHITECT iPhenobarbital assay's performance was established primarily through comparison to a legally marketed predicate device, the AxSYM Phenobarbital assay. The AxSYM Phenobarbital assay itself would have been validated against reference methods for phenobarbital measurement. The correlation coefficient of 1.0 indicates excellent agreement with the existing, validated method.

8. Sample Size for the Training Set

The document does not specify the sample size used for the training set. This information is often proprietary and not typically included in 510(k) summaries for IVD devices, especially for established assay types.

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

Similarly, the document does not detail how the ground truth for any potential training set was established. For an immunoassay like this, the development process would involve extensive analytical validation using characterized samples (e.g., spiked samples, patient samples with confirmed phenobarbital levels via reference methods) to optimize reagents and assay parameters. The ground truth for training would likely be based on these characterized samples and existing, validated methods for phenobarbital measurement.

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The ONLINE TDM Phenobarbital assay is for the quantitative determination of phenobarbital in human serum or plasma on Roche automated clinical chemistry analyzers. Measurements obtained by this device are used in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital.

The ONLINE TDM Phenobarbital assay is for the quantitative determination of phenobarbital in human serum or plasma on Roche automated clinical chemistry analyzers. Measurements obtained by this device are used in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital. The proposed labeling indicates the Roche Hitachi 912, 917 and Modular P analyzers can be used with the Roche ONLINE TDM Phenobarbital reagent kits.

Here's a breakdown of the acceptance criteria and study details for the K071644 device, the ONLINE TDM Phenobarbital assay:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device appear to be implicit in its comparison to a predicate device (COBAS INTEGRA Phenobarbital) and the stated "acceptable results" from evaluation studies. The performance characteristics evaluated were precision, lower detection limit, method comparison, specificity, and interfering substances. The provided data focuses on precision and method comparison.

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

• Precision: Not explicitly stated as a "test set" in the context of individual patient samples, but control materials were used. The sample size would refer to the number of replicates for each control level for the NCCLS precision evaluations. This information is not provided.
• Method Comparison (ONLINE TDM Phenobarbital vs. COBAS FP Phenobarbital):
  • Sample Size: N=53
  • Data Provenance: Not specified, but generally for method comparisons in medical devices, these are laboratory samples, likely prospective. The origin (country/retrospective/prospective) is not detailed.

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

• This device is an in-vitro diagnostic (IVD) for quantitative measurement. The "ground truth" is typically the measurement performed by a reference method or predicate device. There is no mention of human experts establishing ground truth in this context, as it's a quantitative chemical assay.

4. Adjudication Method for the Test Set

• Not applicable. This is a quantitative chemical assay; results are compared directly, not adjudicated by experts for diagnostic interpretations.

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

• No, an MRMC study was not done. This type of study is relevant for medical imaging or diagnostic devices where human readers interpret results, often with and without AI assistance. This device is a quantitative chemical analyzer.

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

• Yes, this is an inherently "standalone" device in its primary function as a laboratory analyzer. It provides a numerical result without direct human interpretation in the measurement process itself. The performance described (precision, method comparison) reflects the standalone analytical capability of the device.

7. The Type of Ground Truth Used

• Precision: The "ground truth" for precision is the expected value of the control material, and the device's ability to consistently measure around that value.
• Method Comparison: The "ground truth" for the method comparison was the results obtained from the COBAS FP Phenobarbital (an existing and presumably validated method). The predicate device (COBAS Integra Phenobarbital) also performed a method comparison against FPIA.

8. The Sample Size for the Training Set

• Not applicable as this is a chemical assay, not a machine learning or AI-driven diagnostic device that typically employs a "training set." The assay's performance is based on its chemical reagents and instrument calibration, not on learning from a dataset.

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

• Not applicable for the reasons stated above (not an AI/ML device with a training set).

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The Seradyn QMS® Topiramate assay is intended for the quantitative determination of topiramate in human serum or plasma on automated clinical chemistry analyzers.

The results obtained are used in the diagnosis and treatment of topiramate overdose and in monitoring levels of topiramate to help ensure appropriate therapy.

The Seradyn QMS® Topiramate assay is a homogeneous particle-enhanced turbidimetric immunoassay. The assay is based on competition between drug in the sample and drug coated onto a micronariticle for antibody binding sites of the topiramate antibody reagent. The topiramate-coated micropariticle peagent is rapidly agglutinated in the presence of the anti-topiramate antibody reagent and in the abserved of any competing drug in the sample. The rate of absorbance change is measured photometrically. When a smale containing topiramate is added, the agglutination reaction is partially inhibited, slowing down the rate of absorbance change. A concentration-dependent classic agglutination inhibition curve can be obtained with maximum rate of agglutination at the lowest topiramate concentration and the lowest agglutination rate at the highest topiramate concentration.

The assay consists of reagents R1: anti-topiramate polyclonal antibody and R2: topiramate-ooated microparticles. A six-level set of Seradyn QMS® Topiramate Cali three-level set of Seradyn QMS® Topiramate Controls is used for quality control of the assay.

Here's an analysis of the Seradyn QMS® Topiramate assay based on the provided 510(k) summary, structured to address your specific points:

Seradyn QMS® Topiramate Assay Study Analysis

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Accuracy: 12 concentrations for recovery study, each analyzed in triplicate (total of 36 measurements).
• Linearity: 9 concentrations, number of replicates not specified.
• Sensitivity (LOQ): Not specified directly, but implies multiple measurements around the LOQ value to determine CV and recovery.
• Precision: 3 controls, N=80 for each (total 240 measurements for precision components).
• Method Comparison: N = 148 patient samples.
• Interference (Endogenous & HAMA): Not explicitly stated, but for each interferent, samples with two known topiramate levels (approx. 5 and 20 µg/mL) were assayed.
• Interference (Co-Administered Drugs): Not explicitly stated, but for each compound, normal human serum with two known topiramate levels (approx. 5 and 20 µg/mL) was assayed.
• Interference (Anticoagulants): Not explicitly stated, but implied comparison of serum and plasma.

Data Provenance: The document does not specify the country of origin of the data. The studies are described as clinical testing, but it's common for these types of in vitro diagnostic studies to use banked or commercially sourced human serum/plasma samples, often without explicit geographical tags in 510(k) summaries. All studies appear to be prospective in the sense that they were designed experiments to evaluate the new device's performance against predefined criteria or a predicate device.

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

This device is an in vitro diagnostic (IVD) assay for quantitative determination of a drug concentration. The "ground truth" here is the actual concentration of topiramate in the samples. This is typically established through:

• Reference materials: For linearity and accuracy by recovery, known concentrations are prepared by precise dilution of a high calibrator.
• Reference method/predicate device: For method comparison, the predicate Innofluor® Topiramate assay serves as the reference for comparison of patient sample results.

Therefore, no human experts were used to establish the "ground truth" in the way they would be for image analysis or disease diagnosis. The "ground truth" is defined by laboratory standards, precise dilutions, and the established performance of a reference or predicate method.

4. Adjudication Method for the Test Set:

Not applicable, as the ground truth is quantitative (actual concentration) and not based on human interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging where multiple human readers interpret cases, and AI assistance might impact their performance. For a quantitative IVD assay, the performance is measured directly by analytical metrics (accuracy, precision, linearity, etc.) and comparison to a predicate device or reference method, not by human reader performance.

6. Standalone Performance:

Yes, the studies described (Accuracy, Linearity, Sensitivity, Precision, Specificity, Interferences, Stability) evaluate the algorithm's entire workflow (reagent interaction, measurement, and result calculation) standalone, without human-in-the-loop performance influencing the primary measurements. The assay quantifies topiramate concentration directly.

7. Type of Ground Truth Used:

• Known concentrations: For Accuracy by Recovery, Linearity, Sensitivity studies. These are prepared laboratory standards.
• Predicate device results: For Method Comparison, the results from the Seradyn Innofluor® Topiramate assay (K970510) on patient samples serve as the comparison point.
• Laboratory-spiked samples: For interference studies, known amounts of interferent and topiramate are added to serum samples.

8. Sample Size for the Training Set:

The document does not provide a sample size for a "training set." This assay is a homogeneous particle-enhanced turbidimetric immunoassay (PETIA), which is a chemical reaction-based method, not a machine learning or AI algorithm that typically requires a large "training set" of data in the common sense. The "development" or "optimization" of the assay would involve various experiments, but these are not usually referred to as a "training set" in the context of conventional IVD development. The calibration of the device uses a six-level set of Seradyn QMS® Topiramate Calibrators, but this is for operational calibration, not model training.

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

As noted above, the concept of a "training set" with established ground truth as in AI/ML is not directly applicable to this type of chemical immunoassay. The "ground truth" for calibrators and controls used in assay development and validation would be established through highly accurate reference methods, gravimetric/volumetric preparation, and traceability to established standards for the analyte (topiramate).

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The Dade Behring Dimension Vista™ Integrated system is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Vista™ system chemical and immunochemical applications utilize photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion selective multisensor technology for clinical use.

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

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

The Phenobarbital Flex® reagent cartridge (PHNO) is intended for the quantitative measurement of phenobarbital in human serum and plasma on the Dimension Vista™ system. Measurements obtained by this device are used in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital to ensure appropriate therapy.

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

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

The Chemistry I calibrator is intended for the calibration of the Urea Nitrogen (BUN) method on the Dimension Vista™ system. The Dimension Vista™ Chem I Calibrator is intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of urea nitrogen in human specimens.

The Protein 1 calibrator is intended for the calibration of the Immunoglobulin G (IGG) method on the Dimension Vista™ system. The Dimension Vista™ Protein I Calibrator is intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of IgG in human specimens.

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

The Drug 1 calibrator is intended for the calibration of the Phenobarbital (PHNO) method on the Dimension Vista™ system. Dimension Vista™ Drug I Calibrator is intended for medical purposes for use in a test system to establish points of reference that are used in the measurement of phenobarbital in human specimens.

The Mass CKMB Isoenzyme calibrator is intended for the calibration of the creatine kinase MB isoenzyme (MMB) method on the Dimension Vista™ system. The Dimension Vista™ MMB Calibrator is intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of mass creatine kinase MB isoenzyme in human specimens.

The V-LYTE™ Standard A & B are intended for the calibration of the Na'/K /Cl methods on the Dimension Vista™ system. The Dimension Vista™ V-LYTE I™ Standard & and Standard B are intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in human specimens.

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

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

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

4. Adjudication Method for the Test Set

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

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

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

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

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

7. The Type of Ground Truth Used

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

8. The Sample Size for the Training Set

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

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

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

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

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The Abbott Aeroset® Phenobarbital Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of phenobarbital in human serum or plasma on the Abbott Aeroset® analyzer (K980367). Monitoring serum phenobarbital concentrations, along with careful clinical assessment, is the most effective means of improving seizure control, reducing the risk of toxicity, and minimizing the need for additional anticonvulsant medication for the following reasons (1-3):

• Serum phenobarbital concentrations correlate better with concentration in the brain than does dosage once steady state is reached.
• Patients taking the same dosage of phenobarbital show considerable variation in serum phenobarbital concentrations because of individual differences in absorption, metabolism, disease states, and compliance. Serum level monitoring helps physicians individualize dosage regimens.

Methods historically used to monitor serum phenobarbital concentrations are gas-liquid chromatography, high-performance liquid chromatography, radioimmunoassay, and immunoassay (1,2).

The Abbott Aeroset™ Phenobarbital Assay is a homogenous enzyme assay intended for use in quantitative analysis of phenobarbital in human serum or plasma.

Here's an analysis of the Abbott Aeroset Phenobarbital Assay based on the provided text, outlining the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify the sample size used for the test set in the comparative analysis or precision studies. It also does not explicitly state the country of origin of the data or whether the study was retrospective or prospective.

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

The document does not mention the use of experts to establish a ground truth for the test set. The evaluation is based on comparison to a predicate device and internal precision measurements.

4. Adjudication Method for the Test Set:

No adjudication method is mentioned as there were no independent experts establishing ground truth. The comparison is made against the results from a predicate device.

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

No, an MRMC comparative effectiveness study was not conducted. This device is an in-vitro diagnostic assay, not an imaging or diagnostic interpretation tool that would typically involve multiple human readers.

6. If a Standalone (Algorithm-Only Without Human-in-the-Loop Performance) Was Done:

Yes, the studies described are standalone performance evaluations of the Abbott Aeroset Phenobarbital Assay itself. The "algorithm" here refers to the homogeneous enzyme immunoassay mechanism. The performance metrics (correlation, precision) are directly attributable to the device's function without human interpretation impacting the measurement results.

7. The Type of Ground Truth Used:

The primary "ground truth" used for performance evaluation is the predicate device's measurements (Emit® 2000 Phenobarbital Assay) and the inherent statistical properties of the assay itself (precision). For the comparative analysis, the ground truth is effectively the results obtained from the previously cleared Emit® 2000 Phenobarbital Assay.

8. The Sample Size for the Training Set:

The document does not specify a training set sample size. This type of in-vitro diagnostic assay is typically developed and optimized through validation studies, rather than "training" in the machine learning sense with a distinct training set. The reported studies are performance verification studies.

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

As there is no explicitly mentioned "training set" in the machine learning context, there is no description of how ground truth for such a set was established. Development and optimization of the assay would have involved standard analytical chemistry validation practices to ensure accuracy and reliability.

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The JMMAGE Immunochemistry System (TDM) CAR. PHE. PHY. and THE Reagents in conjunction with Beckman Drug Calibrator 1, are intended for use in the quantitative determination of carbamazepine. phenobarbital, phenytoin, and theophylline concentrations respectively in human serum and plasma samples on Beckman's IMMAGE Immunochemistry System.

The IMMAGE Immunochemistry System Carbamazepine (CAR) reagent, when used in conjunction with the Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug Calibrator 1, is intended for the quantitative determination of carbamazepine in human serum or plasma bv rate nephelometric inhibition immunoassay.

The IMMAGE Immunochemistry System Phenobarbital (PHE) reagent, when used in conjunction with the Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug Calibrator 1, is intended for the quantitative determination of phenobarbital in human serum or plasma bv rate nephelometric inhibition immunoassay.

The IMMAGE Immunochemistry System Phenytoin (PHY) reagent, when used in conjunction with the Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug Calibrator 1, is intended for the quantitative determination of phenytoin in human serum or plasma by rate nephelometric inhibition immunoassay.

The IMMAGE Immunochemistry System Theophylline (THE) reagent when, used in conjunction with the Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug Calibrator 1, is intended for the quantitative determination of theophylline in human serum or plasma by rate nephelometric inhibition immunoassay.

The IMMAGE™ Immunochemistry Systems Drug Calibrator 1, used in conjunction with IMMAGE reagents, is intended for use on Beckman's IMMAGE Immunochemistry Systems for the calibration of Carbamazepine, Phenobarbital, Phenytoin, and Theophylline test systems.

The JMMAGE Immunochemistry System (TDM) CAR. PHE. PHY. and THE Reagents in conjunction with Beckman Drug Calibrator 1, are intended for use in the quantitative determination of carbamazepine. phenobarbital, phenytoin, and theophylline concentrations respectively in human serum and plasma samples on Beckman's IMMAGE Immunochemistry System.

Here's an analysis of the provided text, focusing on acceptance criteria and study details:

Device: IMMAGE™ Immunochemistry System Therapeutic Drug Monitoring Reagents [Carbamazepine (CAR), Phenobarbital (PHE), Phenytoin (PHY), and Theophylline (THE)]

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided in this document are primarily related to method comparison (correlation with a predicate device), stability, and imprecision. However, explicit numerical acceptance criteria are not stated; instead, the reported performance is presented, demonstrating equivalence to already marketed devices.

Note: The document only provides "Estimated Within-Run Imprecision" without specific numerical values, making it impossible to directly compare to acceptance criteria in a table format. It states generally: "These reagents exhibit acceptable imprecision for the intended use."

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

• Sample Size (Method Comparison - Test Set):
  • Carbamazepine (CAR): 111 samples
  • Phenobarbital (PHE): 103 samples
  • Phenytoin (PHY): 107 samples
  • Theophylline (THE): 144 samples
• Data Provenance: Not specified. It is likely internal data generated by Beckman Instruments, Inc. The document does not mention external sources or specific geographic locations for the samples.
• Retrospective or Prospective: Not specified. Standard practice for method comparison studies like these would typically involve prospective testing of patient samples against the predicate method, but this is not explicitly stated.

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

Not applicable. This is a diagnostic device for quantitative determination of drug concentrations, not an AI or imaging device requiring human expert consensus for ground truth. The "ground truth" for the method comparison study is established by the results from the predicate device (Abbott TDx reagents).

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is not an AI or imaging device requiring human adjudication. The comparison is directly between the new device's measurements and the predicate device's measurements.

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 not an AI device or an imaging device involving human readers.

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

The studies described are standalone performance studies. The IMMAGE™ Immunochemistry System, including these reagents, performs the quantitative determination of drug concentrations without human-in-the-loop interaction for result generation. The performance data presented (method comparison, stability, imprecision) reflects the device's intrinsic analytical capabilities.

7. The Type of Ground Truth Used

The ground truth for the method comparison studies was established by the predicate device's measurements. For example, for Carbamazepine, the Abbott TDx Carbamazepine reagent was used as the reference method.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI-based system that requires a "training set." It is a chemical immunoassay system where reagents react to determine concentrations.

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

Not applicable, as there is no training set for this type of device.

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