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The MTM BioScanner HDL Test Strip is intended for the in-vitro-diagnostic quantitation of HDL Cholesterol in whole blood when used with the MTM BioScanner 1000. This system is intended to be used to assist the healthcare professional in screening for decreased levels of HDL Cholesterol as a risk factor in coronary artery disease.

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The provided text is a 510(k) clearance letter from the FDA for the MTM BioScanner HDL Test Strips. This type of document declares that a new medical device is "substantially equivalent" to an existing legally marketed device. It acknowledges the device's acceptable performance, but it does not contain the detailed study results, acceptance criteria, or ground truth information that you are requesting.

Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, or ground truth establishment based on the provided text. This information would typically be found in the manufacturer's 510(k) submission document itself, which is not included here.

The document only states the device's intended use:
Indications for Use: The MTM BioScanner HDL Test Strip is intended for the in-vitro-diagnostic quantitation of HDL Cholesterol in whole blood when used with the MTM BioScanner 1000. This system is intended to be used to assist the healthcare professional in screening for decreased levels of HDL Cholesterol as a risk factor in coronary artery disease.

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