(37 days)
to measure carbon dioxide concentrations in serum or plasma on the SYNCHRON CX 3 System
CO2 Alkaline Buffer, Procedure Number C7683
Here is an analysis of the provided text based on your request, focusing on the acceptance criteria and study details for the Sigma Diagnostics CO2 Alkaline Buffer:
This 510(k) premarket notification describes a new device (Sigma Diagnostics CO2 Alkaline Buffer) and demonstrates its substantial equivalence to a predicate device (Beckman CO2 Alkaline Buffer Kit). The study's primary goal is to show that the new device performs as safely and effectively as the existing one.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (Sigma Diagnostics CO2 Alkaline Buffer) |
|---|---|---|
| Substantial Equivalence | Demonstrated substantial equivalency to Beckman CO2 Alkaline Buffer Kit | Achieved |
| Correlation | Correlation coefficient with predicate device | 0.992 |
| Regression Equation | Regression equation with predicate device | y = 0.95x + 1.54 |
| Within-run Precision (%CV) | %CV |
§ 862.1160 Bicarbonate/carbon dioxide test system.
(a)
Identification. A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.(b)
Classification. Class II.