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A rapid, competitive binding immunoassay for qualitative determination of morphine in urine.

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This document is a 510(k) clearance letter from the FDA for a medical device called the "One Step Morphine Card Test." It serves as an official notification that the device has been found substantially equivalent to devices marketed prior to May 28, 1976, and can therefore be legally marketed.

However, the provided text does not contain the detailed information necessary to answer your specific questions regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications. This letter primarily focuses on the regulatory clearance for marketing the device.

To answer your questions, I would need to review the actual 510(k) submission document (which is typically a much larger and more detailed technical document submitted by the manufacturer to the FDA), or a public summary of it, if available.

Therefore, based solely on the provided text, I cannot provide the requested information. The document is a regulatory approval letter, not a scientific study report.

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