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This 50 ng/mL cocaine metabolite urine calibrator is intended to be used for calibrating cocaine : metabolite enzyme immunoassay for qualitative and semi-quantitative determination of cocaine and its metabolites in human urine.

The assay results obtained with the cocaine metabolite enzyme immunoassay in combination with the use of such calibrator provide only a preliminary analytical result. A more specific alternate method must be used in order to obtain a confirmed analytical result. Gas chromatograph/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

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The provided text is a letter from the FDA regarding the clearance of a medical device, specifically a "50 ng/mL Cocaine Metabolite Urine Calibrator." It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The letter only states that the device is substantially equivalent to legally marketed predicate devices and is cleared for marketing.

Therefore, I cannot extract the requested information from the provided text.

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