(39 days)
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.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (INNOFLUOR®, Modified) |
|---|---|---|
| Comparison to Abbott Gentamicin Assay | Strong linear correlation and close agreement | Regression Equation: (INNOFLUOR®, Modified) = 0.985 x (Abbott) - 0.107 |
| Correlation Coefficient (r): 0.9928 | ||
| Comparison to INNOFLUOR®, Existing | Strong linear correlation and close agreement | Regression Equation: (INNOFLUOR®, Modified) = 1.037 x (INNOFLUOR®, Existing) - 0.045 |
| Correlation Coefficient (r): 0.9947 |
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.
§ 862.3660 Phenobarbital test system.
(a)
Identification. A phenobarbitol test system is a device intended to measure phenobarbital, an antiepileptic and sedative-hypnotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital to ensure appropriate therapy.(b)
Classification. Class II.