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The INNOFLUOR® Gentamicin Assay System is an in vitro diagnostic device intended for the quantitative determination of total Gentamicin in serum for therapeutic drug monitoring by fluorescence polarization immunoassay. The assay system is for use on the Abbott TDx® or the TDxFLx® analyzer.

The INNOFLUOR® Gentamicin Reagent Set is intended for the quantitative determination of total gentamicin in serum for therapeutic drug monitoring. The reagent set is intended for use in the INNOFLUOR® Gentamicin Assay System.

The INNOFLUOR® Gentamicin Calibrator Set is intended for use in the calibration of the INNOFLUOR® Gentamicin Assay System.

The INNOFLUOR® Gentamicin Assay System is a fluorescence polarization immunoassay intended for the quantitative determination of total gentamicin in serum for therapeutic drug monitoring. The assay system is for use on the Abbott TDx® or the TDxFLx® analyzer. The system consists of the INNOFLUOR® Gentamicin Reagent Set and the INNOFLUOR® Gentamicin Calibrator Set, which are packaged and sold separately.

This 510(k) summary describes a new version of an existing device, the INNOFLUOR® Gentamicin Assay System, referred to as "INNOFLUOR®, Modified." The submission aims to demonstrate substantial equivalence to the previously existing INNOFLUOR® Gentamicin Assay System ("INNOFLUOR®, Existing") and the Abbott Gentamicin Assay. The study described is a comparison study, not a standalone performance study in the traditional sense, as it relies on comparison to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in terms of specific thresholds for the regression analysis (e.g., a minimum correlation coefficient or acceptable slope/intercept range). Instead, the submission implies that showing strong correlation and close agreement to the predicate devices constitutes meeting the acceptance criteria for substantial equivalence.

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

• Sample Size: 69 patient samples
• Data Provenance: The samples were from "patients receiving gentamicin therapy," implying retrospective samples collected from a clinical setting. The country of origin is not explicitly stated in the provided text.

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

Not applicable. This study does not involve expert-established ground truth in the typical sense of diagnostic imaging or clinical interpretation. The "ground truth" for this study is effectively the results obtained from the predicate devices (Abbott Gentamicin Assay and INNOFLUOR®, Existing).

4. Adjudication Method for the Test Set

Not applicable. This is a quantitative assay comparison study, not one requiring adjudication of diagnostic outcomes. The comparison is based on the numerical results of each assay.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a laboratory assay for therapeutic drug monitoring, not an AI-assisted diagnostic imaging device that involves human readers.

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

Yes, in a sense. The INNOFLUOR® Gentamicin Assay System, Modified, is the "algorithm" (the assay system) being tested in a standalone manner against two predicate devices. The study compares the quantitative output of the device itself to the quantitative output of other devices. There is no human intervention in the performance of the assay or the generation of its initial result, beyond sample preparation and loading onto the analyzer.

7. The Type of Ground Truth Used

The "ground truth" for this study is the results obtained from the predicate devices: the Abbott Gentamicin Assay and the INNOFLUOR®, Existing Gentamicin Assay. The study aims to show that the new device's results are equivalent to these established methods.

8. The Sample Size for the Training Set

Not applicable. This device is a biochemical assay and does not appear to involve machine learning models that require a "training set" in the computational sense. The "training" for such assays typically involves method development, optimization, and validation experiments by the manufacturer, rather than a distinct "training set" of patient data for an AI model.

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

As this is not an AI/ML device, the concept of a "training set" and its ground truth in that context does not apply. The development of such an assay would involve extensive analytical validation, including studies of accuracy, precision, linearity, and interference, using reference materials and spiked samples with known gentamicin concentrations. These are internal validation processes by the manufacturer, not typically described as establishing "ground truth for a training set" in a regulatory submission like this.

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The INNOFLUOR® Phenobarbital Assay System is an in vitro diagnostic device intended for the quantitative determination of total Phenobarbital in serum for therapeutic drug monitoring by fluorescence polarization immunoassay. The assay system is for use on the Abbott TDx® or the TDxFLx® analyzer.

The INNOFLUOR® Phenobarbital Reagent Set is intended for the quantitative determination of total phenobarbital in serum for therapeutic drug monitoring. The reagent set is intended for use in the INNOFLUOR® Phenobarbital Assay System.

The INNOFLUOR® Phenobarbital Calibrator Set is intended for use in the calibration of the INNOFLUOR® Phenobarbital Assay System.

The INNOFLUOR® Phenobarbital Assay System is an in vitro diagnostic device used to monitor serum levels of the therapeutic, anticonvulsant drug, phenobarbital. It is a fluorescence polarization immunoassay based on the competitive binding principle. The system consists of two products: the INNOFLUOR® Phenobarbital Reagent Set (containing Phenobarbital Antibody, Phenobarbital fluorescein TRACER, and PRE TREATMENT BUFFER) and the INNOFLUOR® Phenobarbital Calibrator Set (containing human serum with added phenobarbital at various concentrations). The system is for use on the Abbott TDx® or TDxFLx® analyzer.

The provided text is a 510(k) premarket notification for the INNOFLUOR® Phenobarbital Assay System. It describes the device, its intended use, and provides a summary of the components and principles. However, it does not contain the detailed study information or acceptance criteria and performance data that would typically be found in a clinical study report or a more comprehensive technical document.

Therefore, many of the requested items cannot be definitively answered from the provided text. I will provide information based on what is available and indicate when information is missing.

Acceptance Criteria and Device Performance Study (as much as can be inferred/extracted)

1. Table of acceptance criteria and the reported device performance:

The document does not explicitly state quantitative acceptance criteria or present a table of device performance against such criteria. The closest information pertains to demonstrating "quantitative recovery" and "accuracy" through comparison with other methods/materials.

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not explicitly stated. The text refers to "recovery samples" prepared at various concentrations (0.0, 5.0, 7.5, 10.0, 15.0, 20.0, 30.0, 40.0, 60.0 and 80.0 ug/mL) and "multiple lots" of commercially available control materials and proficiency testing samples. It also mentions "patient samples." Specific numbers are absent.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective):
  • Calibrators and Recovery Samples: These are laboratory-prepared samples using human serum (phenobarbital-free normal human serum pool). The origin of this human serum is not specified, but the manufacturing entity (OXIS International, Inc.) is based in Portland, Oregon, USA.
  • Control Materials and Proficiency Testing Samples: These are described as "commercially available," implying they are external, but their specific origin is not detailed.
  • Patient Samples: Mentioned for comparison with a reference assay, but no details on their number or origin.
  • The studies appear to be laboratory-based evaluations of the assay's performance rather than clinical trials with patient cohorts, making the retrospective/prospective distinction less applicable in its typical sense.

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

• This information is not applicable and therefore not provided in the document. The "ground truth" for the calibrators and recovery samples is established by gravimetric preparation with a USP Reference Standard. For control materials and proficiency samples, the "ground truth" is implied to be values published or established by the manufacturers of those materials, often through multi-method analysis, not by individual experts or review panels in the medical imaging sense.

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

• Not applicable as the "ground truth" is established through analytical methods and reference standards, not through expert adjudication of medical cases.

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 for quantitative determination of a drug in serum, not an imaging device or AI-assisted diagnostic tool that involves human "readers" or "interpreters" in the clinical imaging sense.

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

• This is a standalone assay system. The performance described is that of the assay system itself using the Abbott TDx® or TDxFLx® analyzer. There isn't an "algorithm only" component separate from the reagents and analyzer interaction. Human intervention is required for sample preparation, loading, and interpreting the quantitative result displayed by the analyzer. It's not a "human-in-the-loop" application in the AI sense, but rather a standard laboratory assay where human operators execute the procedure.

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

• Analytical Ground Truth:
  • Calibrators and Recovery Samples: Gravimetric preparation by spiking known concentrations of high-purity phenobarbital analyte (United States Pharmacopoeia Reference Standard for Phenobarbital) into phenobarbital-free normal human serum.
  • Control Materials and Proficiency Testing Samples: Published values associated with commercially available materials, often established through round-robin testing or analysis by multiple reference methods.
  • Patient Samples: Comparison against a "reference assay" (Abbott Phenobarbital FPIA is mentioned as a method used for verification, implying it serves as a comparative reference).

8. The sample size for the training set:

• Not explicitly defined within the context of a "training set" for machine learning. This is a traditional immunoassay system. The development and optimization of the antibody and tracer would involve extensive laboratory work, but not in the sense of a discrete "training set" for an algorithm. The "training" for such a system involves selecting optimal reagents and optimizing assay parameters.

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

• As above, not applicable in the machine learning "training set" context. The "ground truth" for developing and optimizing the assay components (antibody selection, tracer purification, buffer formulation) relies on analytical chemistry principles, experimental validation of binding characteristics, and empirical testing to achieve desired assay performance characteristics (e.g., sensitivity, specificity, dynamic range). The "ground truth" during this development phase would be based on known concentrations of phenobarbital and the chemical and immunological properties of the reagents.

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