(73 days)
The cassette COBAS INTEGRA Amikacin MAB contains and in vitro diagnostic reagent system intended for use on the COBAS INTEGRA analyzer for the quantitative determination of amikacin in human serum or heparinized plasma.
The Roche COBAS INTEGRA Amikacin MAB assay contains an in vitro diagnostic reagent system intended for use on the COBAS INTEGRA 700 analyzer for the quantitative determination of amikacin in human serum or heparinized plasma. The COBAS INTEGRA Amikacin MAB assay determinations are made on the COBAS INTEGRA 700 analyzer using the principle of fluorescence polarization. When a fluorescent molecule, or fluorophore, is irradiated with light of the proper wavelength (the excitation wavelength) some of the light is absorbed. Within a few nano-seconds the absorbed light is emitted, although at a longer wavelength (the emission wavelength). Whether or not the emitted light is polarized depends on the freedom of the fluorophore to rotate in solution. A small molecule, such as fluorescein, can rotate rapidly before light emission occurs, resulting in depolarization of the emitted light. In contrast, a fluorescent macromolecule, such as a fluorescein-labeled protein, will rotate much more slowly. Thus, in the time frame between excitation and emission, the macromolecule will have rotated only very slightly and the emitted light will be polarized. Fluorescence polarization is a reproducible function of the drug concentration, and is suitable for the quantitative determination of drug concentrations in serum for the purpose of therapeutic drug monitoring. Surface active agents are used to ensure dissociation of the drug from serum proteins and to prevent nonspecific binding of the tracer. After completion of the assay, the COBAS INTEGRA 700 will calculate automatically the millipolarization units (mP) of the tracer. After mP values have been calculated for the 6 calibrators, the system calculates a best-fit curve for the calibrators using a nonlinear lest squares regression analysis. The concentration of drug in each sample is then interpolated from this curve using its measured mP value.
The provided text is a 510(k) summary for the COBAS INTEGRA Amikacin MAB device, which is an in vitro diagnostic reagent system for quantitatively determining amikacin in human serum or heparinized plasma. This document focuses on establishing substantial equivalence to a predicate device (Roche COBAS INTEGRA Amikacin K954992) rather than presenting a detailed study proving performance against specific acceptance criteria.
The 510(k) summary states that "Modifications of the Roche COBAS INTEGRA Amikacin MAB assay include: changing rabbit polyclonal antibody with mouse monoclonal antibody . and . changing the assay parameters. The modification has resulted in improved: . analytical sensitivity and . specificity." However, it does not provide specific acceptance criteria or the results of a study designed to demonstrate those criteria were met.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor details about a study that proves the device meets those criteria, based solely on the provided text. The document is a declaration of substantial equivalence based on modifications and stated improvements, but actual performance data against defined metrics is not presented.
Here's what I can extract based on the information provided, and what is explicitly missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document. The document claims "improved analytical sensitivity and specificity" but does not provide quantitative targets or results from a study. | Not specified in this document. The document states that modifications led to "improved analytical sensitivity and specificity," but no numerical data or direct comparison to the predicate's performance is provided to demonstrate these improvements or confirm they meet any predefined acceptance criteria. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is an in vitro diagnostic device for quantitative determination of a drug. Ground truth would typically be established through analytical methods (e.g., mass spectrometry, reference assays) rather than expert consensus on images or clinical cases. The document does not describe how ground truth was established for any internal testing.
4. Adjudication method for the test set
- Not Applicable. See point 3.
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 automated in vitro diagnostic assay, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Implied Standard Practice but Not Explicitly Described. The device is an automated in vitro diagnostic assay. Its performance inherently operates as "algorithm only" (or rather, the assay chemistry and instrument's automated processing). However, the specific details of performance testing (e.g., precision, accuracy, linearity, dynamic range) that would comprise a standalone performance study are not provided in this summary. The summary only mentions "improved analytical sensitivity and specificity" due to modifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not specified. For a quantitative assay, ground truth would typically be established by highly accurate reference methods or certified reference materials, but this is not detailed in the document.
8. The sample size for the training set
- Not Applicable / Not Specified. This is an in vitro diagnostic assay based on fluorescence polarization and biochemical reactions, not a machine learning or AI model trained on a dataset in the conventional sense. Therefore, there is no "training set" in the context of AI. If "training set" refers to calibration samples, the document mentions "6 calibrators" for curve fitting.
9. How the ground truth for the training set was established
- Not Applicable / Not Specified. As above, if "training set" refers to calibration, the ground truth for calibrators would typically be established by the manufacturer through rigorous analytical methods (e.g., gravimetric preparation, verification against reference standards), but this is not detailed. The document only mentions that the system fits a "best-fit curve for the calibrators using a nonlinear least squares regression analysis."
§ 862.3035 Amikacin test system.
(a)
Identification. An amikacin test system is a device intended to measure amikacin, an aminoglycoside antibiotic drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of amikacin overdose and in monitoring levels of amikacin to ensure appropriate therapy.(b)
Classification. Class II.