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Randox Laboratories Ltd. Digitoxin Test Kit is an in vitro diagnostic immunoassay for the quantitative determination of digitoxin in serum. Measurements obtained by this device are used in the diagnosis and treatment of digitoxin in the serum and in monitoring levels of digitoxin to ensure appropriate therapeutic levels.

The method includes a suspension of measuring particles coated with digitoxin conjugate. When a sample containing digitoxin is added, the digitoxin in the sample competes with the digitoxin conjugate on the particles for the limited amount of antibody in the reagent. The respective amounts of antibody bound to the digitoxin in the sample and to the digitoxin conjugate on the particles are inversely dependent on the concentration of digitoxin in the sample. The amount of antibody bound to the particles is measured by the agglutination process. When the antibody binds to the particles, agglutination occurs. When digitoxin is present in the sample, partial inhibition of the agglutination process occurs. The degree of agglutination is measured as a change in scattered light as a change in absorbance, proportional to the concentration of digitoxin in the sample.

The provided text is a 510(k) premarket notification letter from the FDA to Randox Laboratories, Ltd. regarding their Digitoxin test system. While it indicates that the device has been found substantially equivalent to a legally marketed predicate device, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. This document is a regulatory approval, not a scientific study report.

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