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The ARCHITECT i Theophylline assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of theophylline in human serum or plasma on the ARCHITECT i System with STAT protocol capability. Theophylline is used in the treatment of bronchospasm associated with bronchial asthma, chronic bronchitis and pulmonary emphysema. The measurements obtained are used in the diagnosis and treatment of theophylline overdose or in monitoring levels of theophylline to help ensure appropriate therapy.

The ARCHITECT i Theophylline Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of theophylline in human serum and plasma.

The ARCHITECT iTheophylline assay is a one-step STAT immunoassay for the quantitative determination of theophylline in human serum or plasma using CMIA technology, with flexible assay protocols, referred to as Chemiflex.

Sample, anti-theophylline coated paramagnetic microparticles, and theophylline acridinium-labeled conjugate are combined to create a reaction mixture. The antitheophylline coated microparticles bind to theophylline present in the sample and to the theophylline acridinium-labeled conjugate. After washing, pre-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 theophylline in the sample and the RLUs detected by the ARCHITECT / System optics.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document provided does not explicitly state pre-defined acceptance criteria with specific numerical thresholds for performance metrics like precision, linearity, and interference. Instead, it uses the phrase "substantially equivalent" to a predicate device (AxSYM® Theophylline II) as the primary measure of a successful evaluation.

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

The document does not explicitly state the sample size used for the test set in the clinical performance study. It only mentions the "non-clinical performance data" and "clinical performance" without specifying the number of samples or patients involved.

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

This information is not applicable and not provided in the document. The "ground truth" for a quantitative diagnostic test like theophylline measurement is typically established by comparison to a reference method (in this case, the predicate device results), not by expert consensus on interpretations.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document. Adjudication methods (like 2+1 or 3+1) are typically used when subjective interpretations are involved, such as in imaging studies. For a quantitative immunoassay, the comparison is directly with the results of the predicate method.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating human interpretation with and without AI assistance, which is not the nature of this submission for a fully automated immunoassay.

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

Yes, the performance described is a standalone (algorithm only) performance. The ARCHITECT i Theophylline assay is an automated chemiluminescent microparticle immunoassay, meaning its performance is evaluated directly without human interpretation influencing the measurement itself. The comparison is between the new automated system and the existing automated predicate system.

7. The Type of Ground Truth Used

The "ground truth" or reference standard used for comparison was the results obtained from the AxSYM® Theophylline II assay. This is a legally marketed predicate device, and the new device's performance is gauged by its correlation and equivalence to this established method.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" sample size. For an immunoassay like this, the development process (which could be considered analogous to "training") would involve various experiments for reagent optimization, calibration curve fitting, and assay parameter setting, but these are generally not referred to as a "training set" in the same way as machine learning models. The performance assessment is against clinical samples or spiked samples, but the number of these used for initial method development versus final validation is not detailed.

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

Since a "training set" in the machine learning sense is not explicitly discussed, the concept of establishing ground truth for it is also not addressed. The development of the assay itself would rely on established laboratory practices, analytical standards, and potentially comparison to existing reference methods during its initial R&D phase, leading to the optimized assay parameters and reagents that are then validated against the predicate device.

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The DGTX method is an in vitro diagnostic test for the quantitative measurement of digitoxin in serum and plasma on the Dimension Vista™ System. Measurements of digitoxin are used in the diagnosis and treatment of digitoxin overdose and in monitoring levels of digitoxin to ensure appropriate therapy.

The DIG method is an in vitro diagnostic test for the quantitative measurement of digoxin in serum and plasma on the Dimension Vista™ System. Measurements of digoxin are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.

The GENT method is an in vitro diagnostic test for the quantitative measurement of gentamicin, an aminoglycoside antibiotic, in human serum and plasma on the Dimension Vista™ System. Gentamicin measurements may be used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.

The NAPA method is an in vitro diagnostic test for the quantitative measurement of N-acetylprocainamide in serum and plasma on the Dimension Vista™ System. N-acetylprocainamide measurements may be used in therapeutic drug monitoring to maintain adequate procainamide therapy.

The PTN method is an in vitro diagnostic test for the quantitative measurement of phenytoin, (dilantin, diphenylhydantoin), an anti-epileptic drug, in human serum and plasma on the Dimension Vista™ System. Phenytoin measurements may be used in the diagnosis and treatment of phenytoin overdose and in monitoring levels of phenytoin to ensure appropriate therapy.

The THEO method is an in vitro diagnostic test for the quantitative measurement of theophylline in human serum and plasma on the Dimension Vista™ System.

Dade Behring Dimension VistaTM Flex® reagent cartridges are prepackaged in-vitro diagnostic test methods (assays) that are specifically designed to be used on the Dade Behring Dimension Vista™ Integrated system, a floor model, fully automated, microprocessor-controlled, integrated instrument system. The Dimension VistaTM 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.

The provided text describes a 510(k) submission for several Dimension Vista™ Flex® reagent cartridges intended for diagnostic testing. The core of the submission is to demonstrate substantial equivalence to previously cleared predicate devices, primarily focusing on a packaging modification that allows these reagents to be used on the Dimension Vista™ integrated system. The reagents themselves and their fundamental scientific technology are stated to be the same as the predicate devices.

Here's an analysis of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state numerical "acceptance criteria" or provide a table of "reported device performance" in the typical sense of a clinical study (e.g., sensitivity, specificity, accuracy against a gold standard). Instead, the demonstration of performance relies on comparative testing to show substantial equivalence to the predicate devices. The implicit acceptance criterion is that the performance of the new Dimension Vista™ Flex® reagent cartridges must be substantially equivalent to that of the predicate Dimension® Flex® reagent cartridges.

The text states: "Comparative testing described in the protocol included in this submission demonstrates substantially equivalent performance." and "Comparative testing also demonstrates substantially equivalent performance."

Since the document is a summary and not the full study protocol, specific performance metrics and their comparison values are not detailed. However, the nature of these in-vitro diagnostic tests typically involves:

• Precision/Reproducibility: Measuring the consistency of results when the same sample is tested multiple times.
• Accuracy/Method Comparison: Comparing the results obtained by the new device against a reference method (in this case, the predicate device results) using patient samples. This often involves statistical methods like regression analysis (e.g., Deming regression) to assess agreement.
• Linearity/Measuring Range: Confirming that the device accurately measures analytes across its claimed analytical range.
• Interference Studies: Assessing the impact of common interfering substances (e.g., hemoglobin, bilirubin, lipids) on the test results.

The key takeaway is that the "acceptance criteria" here are defined by the established performance characteristics of the predicate devices, and the new devices are deemed acceptable if their performance is statistially similar.

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." However, it does not specify the sample size used for the comparative testing (test set) or the data provenance (e.g., country of origin, retrospective or prospective nature of the samples).

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

This information is not applicable in the context of this 510(k) submission. For in-vitro diagnostic (IVD) devices measuring specific analytes, the "ground truth" is typically the quantitative concentration of the analyte as determined by a reference method or the predicate device itself, not by expert consensus on qualitative interpretation. No human experts are described as establishing ground truth for the test set.

4. Adjudication Method for the Test Set:

This information is not applicable. Since the submission concerns quantitative measurements of chemical analytes, there is no need for an adjudication method as would be relevant for subjective medical image interpretation or clinical decision-making.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance:

This information is not applicable. The device is an in-vitro diagnostic reagent cartridge for laboratory analysis, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant.

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

The entire "device" described here (the reagent cartridges used on an automated analyzer) operates in a standalone (algorithm/system only) manner in terms of its measurement process. The Dimension Vista™ system is described as a "floor model, fully automated, microprocessor-controlled, integrated instrument system." The reagents enable this automated system to perform the quantitative measurements without direct human intervention in the measurement execution. Human involvement is in sample preparation, loading, and interpretation of the numerical results delivered by the automated system.

7. The Type of Ground Truth Used:

The ground truth for the performed comparative testing would have been the quantitative concentration of the specific analyte (Digitoxin, Digoxin, Gentamicin, N-acetylprocainamide, Phenytoin, Theophylline) as measured by the predicate device. Since the reagents themselves are stated to be the same as the predicate and only the packaging is modified for a new instrument system, the primary ground truth is established by the well-characterized performance of the predicate device on its intended system for each analyte.

8. The Sample Size for the Training Set:

This document does not mention a "training set" in the context of an algorithm or machine learning model. This is expected as the device is a reagent cartridge for a chemical assay, not a machine learning-based diagnostic. Therefore, information about the training set size is not applicable.

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

As there is no "training set" in the machine learning sense, this information is not applicable. The "training" of such a system involves the development and optimization of the chemical assay reagents and the instrument's detection capabilities during the initial development phases of the predicate devices and the Dimension Vista™ analyzer itself.

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1. For in vitro diagnostic use only. VITROS Chemistry Products CAFFN Reagent Kit is used on the VITROS 5,1 FS Chemistry System to quantitatively measure caffeine (CAFFN) concentration in human serum and plasma of subjects undergoing therapy with caffeine, especially for cases of neonatal apnea.
2. For in vitro diagnostic use only. VITROS TDM Performance Verifier is an assayed control used to monitor performance of ACET, CRBM, DGXN, PHBR, PHYT and CAFFN on VITROS Chemistry Systems.

The VITROS 5,1 FS Chemistry System is a fully automated clinical chemistry analyzer intended for use in the in vitro determination of various analytes in human specimens. The VITROS 5,1 FS Chemistry System is designed for use with VITROS Chemistry Products MicroTip and Thin Film assays.

The system is comprised of four main elements:

1. The VITROS 5,1 FS Chemistry System instrumentation, which provides automated use of the chemistry reagents. The VITROS 5,1 FS Chemistry System was cleared for market by a separate 510(k) premarket notification (K031924).
2. The VITROS Chemistry Products range of MicroTip assays, in this case the VITROS Chemistry Products CAFFN Reagent Kit (Reagents 1 and 2, Buffer and Calibrators) and the VITROS Chemistry Products TDM Performance Verifiers, which are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS CAFFN assay.
3. The VITROS Chemistry Products Thin Film range of products, which are dry, multilavered, analytical elements, coated on polyester supports. The thin film products each have their own 510(k) clearance numbers and were cleared for market for use on the VITROS 5.1 FS Chemistry System through submission of information required by the ODE Guidance Document: "Data For Commercialization Of Original Equipment Manufacturer, Secondary and Generic Reagents For Automated Analyzers". The required information was provided in the VITROS 5,1 FS Chemistry System premarket notification (K031924).
4. Common reagents used by multiple assays on the VITROS System (in this case, VITROS Chemistry Products FS Diluent Pack 3).

The VITROS System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.

This document describes a 510(k) premarket notification for the VITROS Chemistry Products CAFFN Reagent Kit and VITROS Chemistry Products TDM Performance Verifiers I, II, and III.

The primary study establishing substantial equivalence for the CAFFN Reagent Kit is a correlation study comparing its performance to a legally marketed predicate device, the SYVA® Emit® Caffeine Assay.

While the document confirms the device meets the acceptance criteria for substantial equivalence, it does not provide detailed acceptance criteria values or specific performance results in a structured table as requested. However, it does state the key finding of the correlation study.

Here's the information extracted from the provided text, structured to answer your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a numerical format. Instead, it demonstrates substantial equivalence through a correlation study and other supporting studies (precision, expected values, linearity, and specificity summaries are referenced but not detailed). The primary performance metric presented is the correlation between the new device and the predicate device.

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

• Sample Size for Test Set: The document mentions "patient samples" were used in the equivalence study but does not specify the exact number or sample size of patients or samples.
• Data Provenance: Not specified. It's implied to be retrospective or a controlled clinical sample collection, but the country of origin is not mentioned.

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

• Number of Experts: Not applicable. The ground truth (or reference standard in this context) for the test set was established by the predicate device's measurements, not by human expert interpretation.
• Qualifications of Experts: N/A

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The comparison is directly between the new device's readings and the predicate device's readings. There is no human adjudication process involved as it's a quantitative chemical assay.

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

• MRMC Study Done: No. This is a chemical assay, not an imaging or diagnostic interpretation device that would typically involve human readers.

6. Standalone Performance Study (Algorithm only without Human-in-the-loop performance)

• Standalone Study Done: Yes. The correlation study and other tests (precision, linearity, specificity) represent the standalone performance of the VITROS Chemistry Products CAFFN Reagent Kit on the VITROS 5,1 FS Chemistry System. The results are compared against the predicate device, which also operates in a standalone manner.

7. Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for the comparison study was the measurements obtained from the legally marketed predicate device (SYVA® Emit® Caffeine Assay). It can also be considered an "established reference method" for comparing new devices.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a chemical reagent kit for an immunoassay, not a machine learning or AI algorithm that typically has a "training set" in the conventional sense. The development of such assays involves analytical validation, not statistical model training.

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

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set in the AI/ML context for this type of device. The development and optimization of the assay would involve various laboratory methods and reference materials, but these are not referred to as "training sets" with associated "ground truth" in this context.

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The Emit® Caffeine Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of caffeine levels in human serum in subjects undergoing therapy with caffeine, especially in cases of neonatal apnea.

The Emit® Caffeine Assay is a homogeneous enzyme immunoassay technique used for the analysis of specific compounds in biological fluids. The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate deyhdrogenase (G6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the sample can be measured in terms of enzyme activity. Active enzyme converts oxidized nicotinamide adenine dinucleotide (NAD) to NADH. resulting in an absorbance change that can be measured spectrophotometrically.

This document describes the Emit® Caffeine Assay, a homogeneous enzyme immunoassay for the quantitative analysis of caffeine levels in human serum.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria (e.g., a specific correlation coefficient or accuracy range that the device needed to meet to be deemed acceptable). Instead, it presents the results of a method comparison study as evidence of equivalence.

Note: The phrase "excellent correlation" implies a qualitative acceptance, but a specific quantitative threshold for the correlation coefficient is not provided. The study's purpose was to demonstrate "substantial equivalence" to a predicate device for a broader intended use, rather than meeting novel performance criteria.

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

• Sample Size: 110 neonate samples.
• Data Provenance: Retrospective, as all samples were collected from patients who had already received Theophylline or Caffeine. The country of origin is not specified but can be inferred to be the USA given the FDA submission.
  • 31 samples were from patients who had received Theophylline.
  • 79 samples were from patients who had received Caffeine.
  • The values of these samples "spanned the assay range."

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

This type of information is generally not applicable to a diagnostic assay for a chemical compound like caffeine. The ground truth (reference method) was established using High-Performance Liquid Chromatography (HPLC). HPLC is a well-established analytical technique and does not require "experts" in the sense of human readers for interpretation, but rather skilled laboratory personnel to operate the equipment and interpret chromatograms.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by an objective analytical method (HPLC), not by 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 more relevant for imaging devices or other diagnostics where human interpretation plays a significant role. The Emit® Caffeine Assay is an in-vitro diagnostic (IVD) assay that produces a quantitative result, not an image or subjective interpretation.

6. Standalone Performance Study

Yes, a standalone study was implicitly performed. The method comparison study directly evaluated the Emit® Caffeine Assay's performance against HPLC without human intervention in the assay's execution or result generation. The "correlation coefficient = 0.99" refers to the algorithm's (assay's) performance.

7. Type of Ground Truth Used

The type of ground truth used was High-Performance Liquid Chromatography (HPLC). HPLC is a recognized gold standard analytical method for quantifying various substances, including caffeine, in biological samples.

8. Sample Size for the Training Set

The document does not specify a separate "training set" or its sample size. This type of terminology (training set/test set) is more commonly used in machine learning or AI-based device development. For this immunoassay, the "development" or "validation" of the assay's performance characteristics (like linearity, precision, etc.) would have been established during the initial clearance (K853872), and the current submission is focused on demonstrating equivalence for an expanded intended use. The 110 samples mentioned were used for a method comparison study, which serves as a validation (or test) of the device against a gold standard for its expanded indication rather than for training.

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

As no explicit training set is mentioned in the context of this device and study, the method for establishing its ground truth is not applicable. The assay's fundamental characteristics (e.g., dose-response curve, calibration) would have been established using known concentrations of caffeine in a laboratory setting during its initial development, but this is not generally referred to as establishing "ground truth for a training set" in this context.

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The Roche ONLINE Theophylline assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of theophylline, a broncodilator, widely used to treat patients with asthma, apnea (temporary asphyxia), and other obstructive lung diseases. Measurements obtained by this device are used in the diagnosis and treatment of theophylline overdose or in monitoring levels of theophylline to ensure appropriate therapy.

The Roche ONLINE Theophylline assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of theophylline, a bronchodilator, widely used to treat patients with asthma, apnea (temporary asphyxia), and other obstructive lung diseases, in human serum or plasma on automated clinical chemistry analyzers. Measurements obtained by the device are used in the diagnosis and treatment of theophylline overdose and in monitoring levels of theophylline to ensure appropriate therapy. The proposed labeling indicates that the Roche/Hitachi 911, 912, 917, and Modular P analyzers can be used with the Roche ONLINE Theophylline reagent kits.

Here's an analysis of the provided text regarding the "Roche ONLINE Theophylline Assay" and its acceptance criteria and study:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in terms of pre-defined thresholds. Instead, it states that "All of the evaluation studies gave acceptable results compared to the predicate device." This implies that the acceptance criteria were met if the performance of the new device was "substantially equivalent" to the predicate device.

To infer the acceptance criteria, we can look at the performance of the predicate device and the new device. A common approach for method comparison studies for medical diagnostics is to demonstrate a strong correlation (R-value close to 1) and a slope close to 1 with an intercept close to 0, indicating minimal proportional and constant bias. For precision, the CV% should be comparable or better.

Study That Proves the Device Meets Acceptance Criteria:

The study conducted was a performance characteristic evaluation comparing the "Roche ONLINE Theophylline Assay" against the "Roche COBAS INTEGRA Theophylline Assay" (predicate device). The study assessed 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

• Sample Size for Test Set (Method Comparison):
  • Roche ONLINE Theophylline (new device): n = 103
  • Roche COBAS INTEGRA Theophylline (predicate device): n = 138 (This value is for the predicate's comparison against another assay, not directly against the new device for this study. The n=103 is the relevant sample size for comparing the new device to the predicate).
• Data Provenance: Not explicitly stated. However, given that this is an in-vitro diagnostic device manufactured by Roche Diagnostics Corporation in Indianapolis, IN, it is highly likely the data was collected from clinical samples, possibly from multiple sites, but the geographical origin (e.g., country) is not specified. The study is retrospective, as it compares a new assay's results to an existing, legally marketed assay.

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

This information is not provided in the document. For chemical assays like this, "ground truth" often refers to a reference method or a highly accurate, often more laborious, laboratory method. It doesn't typically involve human expert consensus in the same way as medical imaging or clinical diagnoses. The comparison here is against a legally marketed predicate device, not necessarily a "ground truth" reference method established by experts.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1) are common in studies where human interpretation of data (e.g., medical images) can be subjective and multiple readers are involved. For an automated chemical assay comparing numerical results, adjudication by experts is not a standard practice. The comparison is objective, based on direct numerical results between the new device and the predicate device.

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

This information is not applicable. This is an in-vitro diagnostic device (a laboratory blood test), not an AI-powered diagnostic tool for human interpretation of complex data (like radiology images). Therefore, MRMC studies and the concept of human readers improving with AI assistance are not relevant to this device.

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

Yes, this study is inherently a standalone performance study of the device (assay and associated analyzers). The "Roche ONLINE Theophylline Assay" itself is an automated chemical analysis system. The performance metrics presented (method comparison, precision) are reflective of the assay's performance without direct human intervention in the result generation process beyond operating the analyzer and collecting samples.

7. The Type of Ground Truth Used

The "ground truth" in this context is the performance of the legally marketed predicate device (Roche COBAS INTEGRA Theophylline Assay). The study seeks to establish substantial equivalence to this predicate, meaning the new device performs sufficiently similarly. It's not using an independent, gold-standard "ground truth" like pathology or long-term clinical outcomes data, but rather a comparative standard.

8. The Sample Size for the Training Set

This information is not provided and is likely not applicable in the traditional sense for this type of device. The "Roche ONLINE Theophylline Assay" is a chemical reagent system. While there would have been extensive R&D and validation during its development (which might involve testing many samples), these are not typically referred to as a "training set" for an algorithm in the way that machine learning models use them. Chemical assays are developed based on chemical principles and optimized through experimentation, not "trained" on data.

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

As explained above, the concept of a "training set" and its "ground truth" in the context of machine learning is generally not applicable to this chemical assay. The development process would have involved establishing the accuracy and reliability of the chemical reactions and measurement principles through controlled experiments and analytical studies, rather than using a labelled dataset for algorithmic training.

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The Randox Laboratories Ltd. Theophylline Test Kit is an in vitro diagnostic reagent for the quantitative determination of theophylline in serum. The method is a latex-enhanced immunoturbidimetric assay based on the principle of measuring changes in scattered light. Latex particles are coated with theophylline which, in the presence of theophylline antibody solution, rapidly agglutinate. When a sample containing theophylline is introduced the agglutination reaction is partially inhibited, slowing down the agglutination process. The rate of agdutination is inversely dependent on the concentration of theophylline in the sample. By monitoring the change in scattered light as a change in absorbance, a concentration curve can be obtained. The actual change in absorbance is inversely proportional to the concentration of theophylline in the sample.

Measurements obtained by this device are used in the diagnosis and treatment of theophylline overdose and in monitoring levels of theophylline to ensure appropriate therapy.

This Application Sheet has been developed for the Hitachi 717 analyser and must be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

The Randox Laboratories Ltd. Theophylline Test Kit is an in vitro diagnostic reagent for the quantitative determination of theophylline in serum. The method is a latex-enhanced immunoturbidimetric assay based on the principle of measuring changes in scattered light. Latex particles are coated with theophylline which, in the presence of theophylline antibody solution, rapidly agglutinate. When a sample containing theophylline is introduced the agglutination reaction is partially inhibited, slowing down the agglutination process. The rate of agdutination is inversely dependent on the concentration of theophylline in the sample. By monitoring the change in scattered light as a change in absorbance, a concentration curve can be obtained. The actual change in absorbance is inversely proportional to the concentration of theophylline in the sample.

This document is an FDA 510(k) clearance letter for the Randox Laboratories Ltd. Theophylline Test Kit. It lacks the kind of detailed study information you requested for Artificial Intelligence/Machine Learning (AI/ML) powered medical devices. The document refers to a "Theophylline Test System" which is an in vitro diagnostic reagent, not an AI/ML device. Therefore, many of the requested fields are not applicable or cannot be extracted from this document.

However, I can provide the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not contain acceptance criteria or detailed performance data in a table format. It states that the device is "substantially equivalent" to legally marketed predicate devices, which is the primary regulatory hurdle for 510(k) submissions.

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

Not applicable/Not provided. This is an in vitro diagnostic test for a chemical compound, not an imaging/AI device requiring patient data in the typical sense for an AI model.

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

Not applicable. For this type of in vitro diagnostic test, the "ground truth" would be established through analytical validation methodologies, not expert consensus on patient data.

4. Adjudication Method

Not applicable.

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

Not applicable. This is not an AI/ML device, and MRMC studies are typically used for evaluating the impact of AI assistance on human readers interpreting medical images.

6. Standalone (Algorithm Only) Performance Study

The device itself is a standalone in vitro diagnostic test. Its performance would be evaluated through analytical studies (e.g., accuracy, precision, linearity, interference) rather than "algorithm only" performance in the context of AI. The document itself does not contain this detailed performance study data, but rather the FDA's decision based on such submissions.

7. Type of Ground Truth Used

For this type of in vitro diagnostic device, the "ground truth" would be established through:

• Reference Methods: Comparison to established, highly accurate analytical methods for theophylline quantification.
• Known Concentrations: Testing samples with known, precise concentrations of theophylline.
• Clinical Correlation: Demonstrating that the test results correlate with actual patient conditions related to theophylline levels.

The specific "ground truth" for the studies submitted for this 510(k) is not detailed in this clearance letter.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device that uses a "training set" in the conventional sense.

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

Not applicable.

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The ACS:180 and ADVIA Centaur Theophylline 2 Immunoassays are competitive, chemiluminescence immunoassay for the quantitative determination of theophylline in human serum and plasma for use on the automated analyzer manufactured by Bayer Corporation. Theophylline (1,3-dimethylxanthine) is a potent bronchodilator and is very important in the treatment of asthma. Monitoring a patient's theophylline level is very important in reducing the risks of over or under-medication resulting from the wide inter-patient variation in theophylline absorption, metabolism and excretion. The ACS and ADVIA Centaur Theophylline 2 immunoassays are used as an aid to monitor a patient's theophylline level.

The ACS and ADVIA Centaur Theophylline 2 are competitive chemiluminescence immunoassays are intended for the quantitative determination of theophylline in human serum and plasma. Theophylline in the patient sample, calibrators, standards and controls competes with acridinium ester-labeled theophylline in the Lite Reagent for a limited amount of monoclonal mouse anti-theophylline antibody, which is covalently coupled to paramagnetic particles in the Solid Phase. Following incubation, unreacted acridinium esterlabeled theophylline and unreacted theophylline from the sample are washed from the reaction mixture. The chemiluminescence of the reacted, labeled theophylline is measured in a luminometer. The measured chemiluminescence is inversely proportional to the quantity of theophylline in the sample.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Bayer Diagnostics Theophylline 2 Immunoassays:

Acceptance Criteria and Device Performance Study for Bayer Diagnostics Theophylline 2 Immunoassays

The submission describes the substantial equivalence of the new ACS and ADVIA Centaur Theophylline 2 Immunoassays to the predicate ACS Theophylline assay. The primary method for demonstrating this equivalence is through method comparison studies, which establish correlation between the new devices and the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implied by the "substantial equivalence" claim and the reported correlation results, which generally aim for a high correlation coefficient (close to 1) and slopes close to 1 with intercepts close to 0, indicating strong agreement between methods.

Interpretation: All reported correlation coefficients are 0.99, demonstrating excellent agreement. The slopes are close to 1 (0.94, 1.00, 1.05) and intercepts are relatively small (-0.24, -0.9, 1.36), indicating that the new assays perform very similarly to the predicate and to each other.

2. Sample Size and Data Provenance

• Sample Size for Test Set: N = 138 for each comparison.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). It is implied to be human serum and plasma samples based on the intended use.

3. Number of Experts and Qualifications for Ground Truth

• This type of immunoassay study typically does not involve human experts to establish "ground truth" in the way, for example, an imaging study would for disease diagnosis.
• The "ground truth" or reference standard for comparison in this context is the predicate device's performance (ACS Theophylline Assay, K951169). The assumption is that the predicate device's measurements are a reliable reference.

4. Adjudication Method

• None applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple experts independently review cases to establish a consensus ground truth, often for subjective assessments or complex diagnoses. This is not relevant for an immunoassay comparison study where numerical values are being compared.

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

• No. An MRMC study is not mentioned and would not be applicable to an immunoassay device. MRMC studies are used to evaluate the impact of human readers (e.g., radiologists, pathologists) on diagnostic accuracy, often with and without AI assistance. This device is a standalone diagnostic test that produces a quantitative result.

6. Standalone (Algorithm Only) Performance

• Yes. This entire study evaluates the standalone performance of the new immunoassay devices. They are designed to provide quantitative results directly from serum or plasma samples. There is no human-in-the-loop performance component described; the devices measure theophylline levels directly.

7. Type of Ground Truth Used

• Comparison to a Predicate Device's Measurements: The ground truth for this evaluation is defined by the measurements obtained from the existing, legally marketed ACS Theophylline Assay (predicate device K951169). The study seeks to prove that the new devices provide equivalent measurements to this established predicate.

8. Sample Size for Training Set

• Not explicitly stated/not applicable in this context. Immunoassays, by their nature, are typically developed and optimized during formulation and manufacturing, and then validated through performance studies like method comparisons. The term "training set" is more commonly associated with machine learning algorithms. While there would have been internal development and validation during the assay optimization phase, it's not described as a "training set" in the context of this 510(k) submission.

9. How Ground Truth for Training Set was Established

• Not applicable/Not described. As mentioned above, the concept of a "training set ground truth" as used in machine learning is not directly applicable here. The "ground truth" in the validation study refers to the results from the established predicate device. For the development and initial calibration of the new assays, it would typically involve using reference materials with known concentrations of theophylline.

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The Abbott Aeroset® Theophylline Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline in human serum or plasma on the Abbott Aeroset® System.

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990.

Syva Company is submitting the Premarket Notification, 510(k) on behalf of Abbott Laboratories to convey Abbott's intention to commercially market an in vitro diagnostic reagent test kit for the analysis of theophylline in human serum or plasma. The Abbott Aeroset® Theophylline Assay is a homogenous enzyme assay intended for use in quantitative analysis of theophylline in human serum or plasma. The Abbott Aeroset® Theophylline Assay and calibrators has been found to be equivalent to the predicate device: Emit® 2000 Theophylline Assay (K913123) with regard to intended use, assay sample, and overall performance characteristics.

The Abbott Aeroset Theophylline Assay is a homogeneous enzyme immunoassay intended for the quantitative analysis of theophylline in human serum or plasma. The assay is intended to be substantially equivalent to the Emit 2000 Theophylline Assay (K913123).

Here's an analysis of the acceptance criteria and study information:

1. Acceptance Criteria and Reported Device Performance

The document describes performance for two key areas: comparative analysis and precision. It establishes that "excellent correlation" and "acceptable" precision are the acceptance criteria, comparing the Abbott Aeroset Theophylline Assay to the predicate device, the Emit® 2000 Theophylline Assay (K913123).

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated. The document mentions "comparative analysis" and "Precision study" but does not provide the number of samples or subjects used in these studies.
• Data Provenance: Not explicitly stated. There is no mention of the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable for this type of in vitro diagnostic device (immunoassay). The "truth" is established by the reference method (predicate device) and analytical measurements, not by expert consensus on visual interpretation.

4. Adjudication Method for the Test Set

• Not applicable. The quantitative nature of the assay and comparison to a predicate device does not involve adjudication by experts.

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

• Not applicable. This is an in vitro diagnostic device, not an imaging or diagnostic interpretation aid that would involve human readers.

6. Standalone Performance Study

• Yes, a standalone performance study was done in the sense that the Abbott Aeroset Theophylline Assay's performance (precision) was evaluated independently. However, its primary "standalone" claim is substantial equivalence to a predicate device, meaning its performance is considered acceptable if it correlates well with the established predicate. The precision study evaluates the device's inherent variability.

7. Type of Ground Truth Used

• Predicate Device/Reference Method: For the comparative analysis, the "ground truth" or reference was the Emit® 2000 Theophylline Assay (K913123). This is a legally marketed predicate device with established performance.
• Analytical Measurement: For the precision study, inherent analytical measurements of samples at different concentrations were used to determine the variability (%CV).

8. Sample Size for the Training Set

• Not applicable. This device is an immunoassay reagent kit, not a machine learning algorithm that requires a "training set" in the conventional sense. The "training" of the assay is inherent in its chemical and biological design, and its calibration is part of its routine use rather than an external training phase for an algorithm.

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

• Not applicable, as there is no "training set" in the context of a machine learning algorithm. The assay's performance characteristics, including its analytical range and accuracy, are established through internal validation studies by the manufacturer and comparison to a predicate device, as described.

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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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