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The Randox Laboratories Digoxin Assay is an in vitro diagnostic test for the quantitative determination of Digoxin in human serum or plasma. Quantitative measurements are used in the diagnosis and treatment of Digoxin overdose and in monitoring levels of Digoxin to ensure appropriate therapy. This device has been developed for the ADVIA system and is intended for prescription use only.

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The provided text is related to the FDA clearance of the "Randox Digoxin Assay" and specifically mentions its "Indication for Use" and a 510(k) number (K102346). However, the document does not contain the detailed information required to fill out the requested table regarding acceptance criteria, device performance, study details (sample sizes, ground truth, expert qualifications, adjudication, MRMC, standalone performance, training set details).

This type of FDA clearance letter confirms substantial equivalence to a predicate device but typically does not include the raw data or detailed study reports. Those would be found in the 510(k) submission itself, which is not provided here.

Therefore, I cannot provide the requested information from the given text.

To answer your request, I would need a detailed study report, a summary of the 510(k) submission materials, or a document specifically outlining the performance data and acceptance criteria for the Randox Digoxin Assay.

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