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System reagent for the quantitative determination of C-Reactive Protein in human serum on OLYMPUS Analyzers. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. Measurements may also be used as an aid in the identification of individuals at risk for future cardiovascular disease. High sensitivity CRP (hsCRP) measurements, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, may be useful as an independent marker of prognosis for recurrent events, in patients with stable coronary disease or acute coronary syndromes.

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This document is a 510(k) clearance letter for a medical device called "Olympus CRP Latex Immunoturbidimetric Reagent." It does not contain a study that describes acceptance criteria and device performance in the way requested by the prompt for an AI/ML device.

This document is primarily concerned with the regulatory clearance process for a diagnostic reagent, affirming its "substantial equivalence" to legally marketed predicate devices. It does not provide details of specific performance studies or acceptance criteria tables relevant to AI/ML device evaluation.

Therefore, I cannot extract the requested information from the provided text. The prompt asks for information pertaining to studies and acceptance criteria for an AI/ML device, which is not what this document describes.

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