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The Olympus AFP assay is a paramagnetic particle (Dynabeads®), chemiluminescent immunoassay for the quantitative determination of alpha-fetoprotein levels in human serum and lithium heparin plasma using the Olympus AU3000i Immunoassay System. The Olympus AFP assay is intended for use as an aid in the management of patients with non-seminomatous germ cell tumors.

For in vitro diagnostic use only.

The Olympus AFP Calibrator is for calibrating the quantitative Olympus AFP assay on the Olympus AU3000i Immunoassay System.

The Olympus AFP Control is used for quality control of the Olympus AFP assay on the Olympus AU3000i Immunoassay System.

The Olympus Alpha-fetoprotein (AFP) Test System is a paramagnetic particle (Dynabeads®), chemiluminescent immunoassay for the quantitative determination of alpha-fetoprotein levels in human serum and lithium heparin plasma using the Olympus AU3000i Immunoassay System.

The provided text is a 510(k) premarket notification acceptance letter for the Olympus AFP Test System. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter acknowledges that the device is substantially equivalent to a legally marketed predicate device but does not detail the performance metrics or study design.

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

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System reagent for the quantitative determination of Direct Bilirubin in human serum on OLYMPUS analyzers.

Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

For in vitro diagnostic use.

The Olympus Direct Bilirubin Reagent (OSR6X181) is a system reagent.

The provided text is a 510(k) premarket notification acceptance letter from the FDA for a medical device called "The Olympus Direct Bilirubin Reagent (OSR6X181)". This type of document confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed.

However, this document does not contain the detailed study information, acceptance criteria, or performance data that would allow me to fill out the requested table and answer the specific questions about device performance and validation studies.

The letter focuses on regulatory approval based on substantial equivalence, rather than providing the performance data from the studies that supported that equivalence. To answer your questions, I would need access to the actual 510(k) submission, which typically includes the detailed study reports.

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

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The Olympus BhCG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total beta human chorionic gonadotropin (intact BhCG and free ß) levels in human serum using the Olympus AU3000i Immunoassay System. Total BhCG is used for the early detection of pregnancy. For in vitro diagnostic use only.

The Olympus ßhCG Calibrator is for calibrating the quantitative Olympus ßhCG assay on the Olympus AU3000i Immunoassay System.

The Olympus BhCG Control is used for quality control of the Olympus BhCG assay on the Olympus AU3000i Immunoassay System.

The Olympus Total BhCG Test System (OS210303). The Olympus BhCG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total beta human chorionic gonadotropin (intact BhCG and free ß) levels in human serum using the Olympus AU3000i Immunoassay System.

I am sorry, but the provided text does not contain the acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) clearance letter from the FDA for the Olympus Total BhCG Test System, confirming its substantial equivalence to a legally marketed predicate device. It defines the device, its intended use, and regulatory information but does not include details on specific performance metrics, acceptance criteria, or a study report.

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