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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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