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Randox Ethanol Assay: The Randox Ethanol Assay is an in vitro diagnostic test for the quantitative analysis of Ethanol in human urine and serum on the forme analysers, which includes the JX day to na™ and the Amota™ analysers. The measurement of ethanol is used for the diagnosis and treatment of alcohol intoxication and poisoning. This is an in vitro diagnostic device intended for prescription use only.
Randox Ethanol Calibrator Set: The Randox Ethanol Calibrator Set is intended for the Randox Ethanol assay, which is used for the quantitative analysis of ethanol in human urine and serum on the December analysers which includes the X day to na™ and the 121mona™.
Randox Ethanol Control Set: The Randox Ethanol Control Set is intended for the quality control of the Randox Ethanol assay, which is used for the quantitative analysis of ethanol in human urine and serum on the forme analysers which includes the Aday to na™ and the Mimola™. This is an in vitro diagnostic device intended for prescription use only.

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The provided text is a 510(k) premarket notification for an in vitro diagnostic device (Randox Ethanol Assay and Calibrators/Controls). It does not contain information about acceptance criteria, device performance, or a study report with details like sample sizes, expert qualifications, or ground truth establishment. This type of document primarily confirms that the device is substantially equivalent to a legally marketed predicate device and outlines regulatory compliance.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number of experts, adjudication methods, or ground truth types for a test set.
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.
• Sample size for the training set or how ground truth was established for it.

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