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The Olympus Creatine Kinase reagent is intended for use in Olympus automated clinical The Organisation of creatify the quantitative determination of creatine kinase activity in human serum and plasma.

Measurements of creatine kinase are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

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I am sorry, but the provided text from the FDA 510(k) approval letter for the "Olympus Creatine Kinase Reagent" does not contain the specific information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

This document is a formal letter of clearance where the FDA determines that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. It outlines regulatory requirements and contact information but does not include the detailed technical study results or performance data that would typically be found in the 510(k) submission itself.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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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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The Creatine kinase Reagent is to be used in the assessment of cardiac and skeletal muscle diseases, including myocardial infarction and muscle dystrophy.

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The provided text is a 510(k) clearance letter from the FDA for a Creatine Kinase Reagent. It states that the device has been found substantially equivalent to a predicate device for the assessment of cardiac and skeletal muscle diseases, including myocardial infarction and muscle dystrophy.

However, the document does not contain any information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, or training set details. These are typical requirements for device validation studies, but this specific FDA letter is a regulatory clearance document, not a detailed study report.

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

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