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The UriScan Optima II Urine Analyzer is an automated system for use with UriScan Strip. For routine urinalysis through the analysis of blood, bilirubin, urobilinogen, ketones, protein, nitrite, glucose, pH, specific gravity, and leukocytes, as well as the determination of color.

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The provided text is a 510(k) premarket notification letter from the FDA for a device called "UriScan Optima II Urine Analyzer." It broadly approves the device for marketing and mentions its intended use. However, it does not contain any information regarding acceptance criteria, study details, or performance metrics that would allow me to answer your specific questions.

The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates that the device was deemed substantially equivalent to existing devices, but the specific studies and acceptance criteria that led to this determination are not included in the provided text.

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