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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 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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For in vitro diagnostic use only. VITROS PHBR slides quantitatively measure phenobarbital (PHBR) concentration in serum and plasma.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a device called "VITROS Chemistry Products PHBR Slides." This document does not contain information about acceptance criteria or a study proving the device meets those criteria.

The 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials to establish new performance metrics against specific acceptance criteria. The letter confirms that the FDA has reviewed the submission and found the device substantially equivalent for its intended use, allowing it to be marketed.

Therefore, I cannot provide the requested information based on the given input, as the document does not detail device performance, study designs, sample sizes, ground truth establishment, or expert adjudication methods.

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