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The safety and effectiveness of Sigma Diagnostics Electrolyte Reference Reagent, Procedure Number E3891, are demonstrated by its substantial equivalency to Beckman Electrolyte Reference Reagent Kit, Part No. 443315. Both electrolyte reference reagents are used to measure sodium, chloride, potassium, and carbon dioxide concentrations in serum or plasma, sodium, potassium, and chloride concentrations in urine, and chloride concentrations in CSF on the SYNCHRON CX®3 System, and the reaction principles for both reagents are identical.

The Sigma Diagnostics methods use ion selective electrodes for determining sodium, potassium, and chloride and rate of pH change for determining carbon dioxide on the SYNCHRON CX®3 System.

The provided text describes the performance of the Sigma Diagnostics Electrolyte Reference Reagent (Procedure Number E3891) in comparison to the Beckman Electrolyte Reference Reagent Kit (Part No. 443315) on the SYNCHRON CX®3 System. The study aims to demonstrate substantial equivalence.

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1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" as defined thresholds for correlation coefficients or regression equations. Instead, it presents the achieved performance metrics as evidence of substantial equivalence to the predicate device. The implied acceptance is that the correlation and regression fall within an acceptable range for a substantially equivalent device. Similarly, for precision, the stated %CVs are the achieved performance, implying these are considered acceptable.

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