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UriTest- Protein in Urine is a non-quantitative screening test to identify protein in urine. Protein in urine can be associated with renal, kidney or bladder disease.

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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 an FDA 510(k) clearance letter for the "Uri-Test Protein in Urine" device, stating that it is substantially equivalent to a predicate device.

The letter mentions:

• Device Name: Uri-Test - Protein in Urine
• Indication for Use: A non-quantitative screening test to identify protein in urine. Protein in urine can be associated with renal, kidney, or bladder disease.
• Regulatory Class: I
• Product Code: JIR

However, it does not include:

• A table of acceptance criteria or reported device performance.
• Details about sample size, data provenance, or ground truth for any study.
• Information about expert involvement, adjudication, or MRMC studies.
• Data on standalone algorithm performance or training set details.

This document is a notification of regulatory clearance, not a study report or a summary of performance data.

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