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The CAPILLARYS URINE kit is designed for the preparation of urine samples before separation of human urine proteins in alkaline buffer (pH 9.9) with the CAPILLARYS system. The CAPILLARYS performs automatically all sequences to obtain a urinary protein profile for qualitative analysis. The proteins, separated in silica capillaries, are directly detected at an absorbance of 200 nm. The electrophoretograms can be interpreted visually to detect for any pattern abnormalities (monoclonal components, particularly Bence Jones proteins and other urinary proteins). The test results should be used in conjunction with clinical and laboratory findings.

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I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria and the study that proves the device meets them.

The document is an FDA 510(k) clearance letter for the CAPILLARYS URINE device. It confirms that the device is substantially equivalent to a legally marketed predicate device but does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, or details about the test set.
• Information on experts, adjudication methods, or ground truth establishment for a test set.
• Details about multi-reader multi-case studies or standalone algorithm performance.
• Training set sample size or how its ground truth was established.

This document is a regulatory approval, not a scientific study report.

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