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Diazyme Potassium Enzymatic Assay Kit in conjunction with Diazyme Potassium Low and High Calibrators, are intended for the quantitative in vitro determination of potassium in serum. Results obtained by this assay are used to monitor fluid and electrolyte balance.

Diazyme Potassium Enzymatic Assay has controls for normal serum potassium level and abnormal serum potassium level. These controls are used as reference samples for checking the functionality of the Diazyme Potassium Enzymatic Assay.

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The provided text is a 510(k) clearance letter for the Diazyme Potassium Enzymatic Assay Kit. It primarily focuses on the regulatory approval process and states the device's intended use. It does not contain specific information about:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets or their data provenance.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication method for the test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies or their effect sizes.
6. Standalone algorithm performance.
7. The type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Therefore, I cannot provide the requested information based on the input text. This document is a regulatory approval notice, not a scientific study report detailing performance metrics and study design.

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