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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 Olympus Myoglobin reagent is intended to be utilized for the quantitative determination of myoglobin in human serum on Olympus analyzers. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for the Olympus Myoglobin Turbidimetric Reagent. This document is a regulatory approval and does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement in a performance study for a device.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent...". This means the clearance is based on a comparison to a legally marketed predicate device, not necessarily a new, extensive performance study with the specific details you are asking for.

Therefore, I cannot provide the requested information based on the input text.

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The Olympus Serum Protein Multicalibrator, catalog number ODR3023, is designed for use in Olympus automated clinical chemistry analyzers for α-1-acidoglycoprotein, α-1-antitrypsin, haptoglobin and ß-2-microglobulin determinations.

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The provided text is a 510(k) premarket notification letter from the FDA regarding a Serum Protein Multicalibrator. This document is a regulatory approval letter and does not contain detailed information about the acceptance criteria or a study proving the device meets those criteria. Such information would typically be found in the 510(k) submission itself, which is not provided.

Therefore, I cannot extract the requested information. The document only states that the FDA has determined the device is "substantially equivalent" to previously marketed devices.

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The Olympus Calcium Arsenazo Reagent is intended for the quantitative determination of Calcium concentrations in human serum on Olympus clinical chemistry analyzers.

Olympus Calcium Arsenazo Reagent

This document is a 510(k) clearance letter from the FDA for the Olympus Calcium Arsenazo Reagent. It does not contain information about the acceptance criteria or a study proving the device meets said criteria in the format requested. The document primarily discusses the substantial equivalence of the device to pre-amendment devices and regulatory information.

Therefore, I cannot provide the requested information based on the provided text.

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