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The Multigent® Gentamicin assay is intended for the quantitative determination of Gentamicin in human serum or plasma on the Architect C8000 System. The results obtained are used in the diagnosis and treatment of Gentamicin overdose and in monitoring levels of Gentamicin to ensure appropriate therapy.

The Multigente Gentamicin assay system is a homogeneous assay utilizing particle agglutination technology and is based on the competitive binding principle. The assay consists of reagents R1: anti-gentamicin monoclonal antibody and R2: gentamicin-coated microparticles. A six-level set of Multigent" Gentamicin Calibrators (A through F) is used to calibrate the assay.

This document describes the acceptance criteria and the studies performed to demonstrate the performance of the Multigent® Gentamicin assay.

1. Table of Acceptance Criteria and Reported Device Performance:

Note regarding Rheumatoid Factor interference: The reported % Recovery (132.34%) for Rheumatoid Factor at 582 IU exceeds the stated acceptance criteria of 100 ± 10%. This indicates potential interference from high levels of Rheumatoid Factor, which should be noted in the device labeling.

2. Sample Size and Data Provenance:

• Accuracy: 5 samples (0.25, 1.00, 2.25, 4.50, 8.00 µg/mL) each run in triplicate (total of 15 measurements in the table shown). Data provenance not specified (retrospective/prospective, country of origin).
• Linearity: 4 serially diluted samples (6.88, 5.16, 3.44, 1.72 MG/ML) each run in triplicate (total of 12 measurements in the table shown). Data provenance not specified.
• Precision: 3 control levels (low, mid, high) tested, with N=80 for each (number of replicates over time). Data provenance not specified.
• Sensitivity: Calibrator A (0 µg/mL) run for a total of 20 replicates. Data provenance not specified.
• Interferences (Endogenous Substances):
  • Bilirubin: 3 replicates for "N=3" (interpreted as the number of independent samples or measurement replicates, as the "N" column is inconsistent).
  • Hemoglobin: 2 replicates for "N=2".
  • Triglyceride, Total Protein: "N" is listed as a non-numeric character (presumably an error in transcription, but the text mentions "run in triplicate" for triglyceride and total protein).
  • Rheumatoid Factor: "N" is listed as a non-numeric character (text mentions "run in triplicate").
  • Data provenance not specified.
• Interferences (HAMA): Duplicate HAMA samples (Type-1 and Type-2) and duplicate control samples. Data provenance not specified.
• Interferences (Common Co-Administered Drugs): Test samples and control samples assayed in duplicate for each drug. Data provenance not specified.
• Anticoagulants: Blood drawn from at least ten healthy donors for each of the 9 tube types. Samples were spiked with Gentamicin and run in duplicate. Data provenance not specified.
• Method Comparison: 55 serum and plasma samples, ranging from 0.78 to 9.02 µg/mL Gentamicin. Data provenance not specified.

3. Number of Experts used to establish the ground truth for the test set and the qualifications of those experts:

This device is an in vitro diagnostic (IVD) assay for quantitative determination of a drug concentration. The "ground truth" for chemical concentration assays is typically established by reference methods, primary standards, or gravimetric/volumetric preparation of known concentrations. There is no mention of human "experts" establishing ground truth in the traditional sense of clinical opinion (e.g., radiologists, pathologists). The ground truth for performance studies like accuracy and linearity is based on the theoretical concentrations of prepared samples or reference materials. For method comparison, the predicate device (Abbott TDx®/TDxFLx® Gentamicin assay) serves as the reference method.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. Adjudication methods are typically used in studies involving subjective assessment (e.g., image interpretation) where multiple readers provide independent evaluations that might conflict. For quantitative chemical assays, the result is a numerical value, and "adjudication" is not a standard practice. Statistical methods are used to compare results to expected values or reference methods.

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 an in vitro diagnostic assay, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is irrelevant.

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

The performance studies described (Precision, Accuracy, Linearity, Sensitivity, etc.) represent the standalone performance of the Multigent® Gentamicin assay system. The device itself generates a quantitative result without direct human interpretation of a visual output. The human-in-the-loop would be the laboratory personnel operating the Architect C8000 System and interpreting the numerical result in a clinical context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth for this device's performance relies on:

• Theoretical Concentrations: For accuracy, linearity, and sensitivity studies, known concentrations of Gentamicin in control matrices serve as the ground truth. These are typically prepared using gravimetric or volumetric methods with highly pure reference standards.
• Reference Method: For the method comparison study, the Abbott TDx®/TDxFLx® Gentamicin assay served as the reference (or comparative) method, with its results considered the "ground truth" for evaluating the new device's correlation.

8. The sample size for the training set:

Not applicable. This device is a chemical immunoassay, not a machine learning or artificial intelligence system that requires a "training set" in the computational sense. The assay works based on established biochemical principles and reagents rather than being "trained" on data.

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

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

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The ACS:180 and ADVIA Centaur Valproic Acid Immunoassays are competitive, chemiluminescence immunoassay for the quantitative determination of valproic acid in human serum and plasma for use on the automated analyzers marketed by Bayer Corporation. Valproic acid (2-propylpentanoic acid) is an anticonvulsant that is used alone or in combination with other anticonvulsant drugs to control seizures. Monitoring of valproic acid ensures that there is adequate drug in the blood stream without being at toxic levels. The ACS:180 and ADVIA Centaur Valproic Acid Immunoassays are used as an aid to monitor patients' valproic acid level.

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

The document describes a 510(k) premarket notification for the ADVIA Centaur and ACS:180 Valproic Acid Immunoassays. This is not a study that uses AI. The acceptance criteria and the study presented are for establishing substantial equivalence to a predicate device, the TDx Valproic acid assay, based on method comparison using correlation studies.

Here's an analysis of the provided information within the context of your request, noting where the information is not applicable due to the nature of the device (an immunoassay, not an AI device):

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for substantial equivalence are inferred from the correlation study results, which show a strong linear relationship and high correlation coefficient between the new devices and the predicate. While explicit numerical acceptance criteria (e.g., "slope between 0.9 and 1.1") are not directly stated as "acceptance criteria," the reported performance demonstrates that these criteria were met for substantial equivalence.

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

The document refers to the data as "correlation studies" and does not explicitly differentiate between "test set" and "training set" in the context of machine learning. Thus, the sample sizes provided are for the datasets used in these correlation studies.

• Sample sizes for correlation studies (acting as test sets):
  • ADVIA Centaur Valproic acid vs. TDx valproic acid: N = 250
  • ACS:180 Valproic acid vs. TDx valproic acid: N = 250
  • ADVIA Centaur Valproic acid vs. ACS:180 Valproic acid: N = 253
• Data Provenance: Not specified. It's common for such studies to use clinical samples, but the country of origin or whether they were retrospective/prospective is not mentioned.

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

This information is not applicable as the ground truth for an immunoassay is typically established by the reference method (the predicate device, TDx Valproic acid assay) or by laboratory standards and calibrators, not by expert human graders or consensus. The "ground truth" here is the measurement obtained from the established method.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies among human experts (e.g., radiologists, pathologists) who are establishing ground truth for subjective interpretations, especially in AI studies. For an immunoassay, the "ground truth" is a quantitative measurement, and disputes are resolved through quality control, calibration, and repeat testing, not expert adjudication in the traditional sense.

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. The device is a quantitative immunoassay, not an AI diagnostic tool that assists human readers. Therefore, an MRMC study and analysis of human reader improvement with AI assistance were not performed.

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

This information is not applicable in the context of an AI algorithm. The performance presented is inherently "standalone" in the sense that it's the performance of the immunoassay itself in comparison to a predicate, not an AI algorithm. There is no human-in-the-loop component for reading/interpreting the immunoassay results that would be "assisted" by AI.

7. The Type of Ground Truth Used

The "ground truth" for the comparison studies was established by the predicate device, the TDx Valproic acid assay. This means the new devices (ADVIA Centaur and ACS:180) were compared against an already legally marketed and accepted method for measuring valproic acid.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of algorithm development, as this is an immunoassay, not an AI-driven device. The term "training set" is typically used for machine learning. The studies described are method comparison studies.

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

This information is not applicable as there is no "training set" for an AI algorithm described in the document.

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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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