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For the quantitative determination of carbon dioxide in human serum. For In Vitro diagnostic use.

Elevated blood CO2 is almost synonymous with respiratory acidosis. The latter is restricted to clinical conditions with a primary increase in carbon dioxide in the inspired air or increased metabolic production of carbon dioxide.

Decreased blood CO2 is almost synonymous with respiratory alkalosis. The latter is restricted to clinical conditions with a primary decrease in carbon dioxide which can result from increased pulmonary ventilation due to mechanical ventilation of the respiratory center (1).

Classic techniques for the measurement of carbon dioxide (CO-) involve the addition of acid to liberate the carbon dioxide and the measurement of carbon dioxide thus released by either manometric, volumetric, or titrimetric techniques. These procedures are both time consuming and cumbersome. The DCL Carbon Dioxide-SL procedure is an enzymatic procedure, employing phosphoenolpyruvate carboxylase (PEPC) (2) and a stabilized NAD analog, which is easy to use and applicable to routine laboratory instrumentation.

This document is an FDA 510(k) clearance letter for a device called "Carbon Dioxide-SL Assay" (Cat. No. 253-01). The letter indicates that the device has been found substantially equivalent to a predicate device for the quantitative determination of carbon dioxide in human serum.

However, the provided text does not contain any information regarding acceptance criteria or the study that proves the device meets those criteria. The letter is a regulatory approval document and does not detail the technical performance data or study specifics. It primarily states that the device is substantially equivalent to a previously marketed device and can therefore be marketed.

Therefore, I cannot provide the requested information based on the given input. The document is a clearance letter, not a performance study report.

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