(177 days)
The Randox Laboratories Limited Amikacin Test Kit is an in vitro diagnostic reagent for the quantitative determination of amikacin in serum. Measurements obtained by this device are used in the diagnosis and treatment of patients receiving therapy with amikacin by monitoring levels of amikacin to ensure appropriate therapy.
The method is a latex-enhanced immunoturbidimetric assay based on the principle of measuring changes in scattered light. Latex particles are coated with amikacin, which in the presence of amikacin antibody Solution, agglutinate. When a sample containing amikacin is introduced the agglutination reaction is partially inhibited, slowing down the agglutination process. The rate of agglutination is measured in scattered light as a change in absorbance. By monitoring the change in absorbance the concentration of amikacin in the sample can be determined. The change in absorbance is inversely proportional to the concentration of amikacin in the sample.
The provided text is a 510(k) premarket notification approval letter for the Randox Laboratories Ltd. Amikacin Test Kit. This document does not describe a study involving detailed acceptance criteria, device performance tables, sample sizes for test/training sets, expert qualifications, or adjudication methods in the context of image analysis or diagnostic performance as typically seen for AI/ML devices.
Instead, this document is a regulatory approval for an in vitro diagnostic reagent for quantitative determination of amikacin in serum using a latex-enhanced immunoturbidimetric assay. The "performance" in this context refers to the assay's chemical and analytical characteristics (e.g., sensitivity, specificity, linearity, precision), which are typically established through laboratory validation studies, not clinical studies with human readers or ground truth established by experts in the same way as an AI diagnostic device.
Therefore, I cannot extract the requested information as it is not present in the provided text. The document confirms that the device is "substantially equivalent" to legally marketed predicate devices, implying that its analytical performance has been demonstrated to be comparable to existing tests for the same purpose.
§ 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.