(74 days)
The Randox Laboratories Ltd. Gentamicin Test Kit is an in vitro diagnostic reagent for the quantitative determination of gentamicin in serum. The method is a latex-enhanced immunoturbidimetric assay based on the principle of measuring changes in scattered light. Immunoglobulin is covalently coupled to latex particles which will agglutinate in the presence of gentamicin antibody. When a sample containing gentamicin is introduced the agglutination reaction is partially inhibited, slowing down the agglutination process. The rate of agglutination is inversely dependent on the concentration of gentamicin in the sample. By monitoring the change in scattered light or absorbance, a concentration curve can be generated. The rate of change in scattered light or absorbance is inversely proportional to the concentration of gentamicin in the sample.
Measurements obtained by this device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.
These Application Sheets have been developed for the Hitachi 717 and Advia 1650 analysers and are for use by suitably qualified laboratory personnel under appropriate laboratory conditions.
The Randox Laboratories Ltd. Gentamicin Test Kit is an in vitro diagnostic reagent for the quantitative determination of gentamicin in serum. The method is a latex-enhanced immunoturbidimetric assay based on the principle of measuring changes in scattered light. Immunoglobulin is covalently coupled to latex particles which will agglutinate in the presence of gentamicin antibody. When a sample containing gentamicin is introduced the agglutination reaction is partially inhibited, slowing down the agglutination process. The rate of agglutination is inversely dependent on the concentration of gentamicin in the sample. By monitoring the change in scattered light or absorbance, a concentration curve can be generated. The rate of change in scattered light or absorbance is inversely proportional to the concentration of gentamicin in the sample.
The provided text is related to a 510(k) premarket notification for a Gentamicin Test Kit. It includes the FDA's letter of substantial equivalence and the indications for use. However, it does not contain any information regarding acceptance criteria, study details, device performance metrics, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them, as this information is not present in the provided document.
§ 862.3450 Gentamicin test system.
(a)
Identification. A gentamicin test system is a device intended to measure gentamicin, an antibiotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.(b)
Classification. Class II.