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The Olympus Creatine Kinase reagent is intended for use in Olympus automated clinical chemistry analyzers for the quantitative determination of creatine kinase activity in human serum. Measurements of creatine kinase are used in the diagnosis and treatment of myocardial infarction and muscle disease, such as progressive Duchenne-type muscular dystrophy.

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The provided text is a 510(k) premarket notification letter from the FDA regarding the Olympus Creatine Kinase Reagent. It confirms that the device is substantially equivalent to legally marketed predicate devices and can proceed to market. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, or details about the studies mentioned in sections 2 through 9, as this information is not present in the provided document.

The document primarily focuses on:

• The FDA's determination of substantial equivalence for the Olympus Creatine Kinase Reagent.
• The regulatory classification (Class II).
• The intended use of the device (quantitative determination of creatine kinase activity in human serum for diagnosis and treatment of myocardial infarction and muscle disease).
• General regulatory requirements for marketing the device.

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