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The Randox Laboratories Limited Direct LDL Cholesterol Test Kit is an in vitro diagnostic reagent for use in the quantitative determination of LDL Cholesterol in serum and plasma. The method, an elimination enzymatic assay, does not require any sample preparation.

Accurate measurement of LDL Cholesterol is of vital importance in therapies that focus on lipid reduction to prevent atherosclerosis or reduce its progress.

Suitably qualified laboratory personnel under appropriate laboratory conditions must use this Test Kit.

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The provided document is a 510(k) premarket notification letter from the FDA for a Direct LDL Cholesterol Test Kit. This document approves the marketing of the device based on its substantial equivalence to a legally marketed predicate device.

However, the document does not contain the detailed information required to answer your specific questions about acceptance criteria and the study that proves the device meets them. It primarily focuses on the regulatory approval process and the administrative aspects of getting the device to market.

The information requested in your prompt (acceptance criteria table, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is typically found in the device's 510(k) submission itself, specifically in sections detailing the performance studies. These sections are usually much more extensive than the approval letter provided here.

Therefore, I cannot provide the requested information based on the given document.

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