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For the quantitative determination of carbon dioxide in 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).

The DCL Carbon Dioxide-L3K assay is an enzymatic procedure, employing phosphoenolpyruvate carboxylase (PEPC) (2) and a stabilized NAD analog (3), which is easy to use and applicable to routine laboratory instrumentation.

I am sorry, but based on the provided text, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for a device named "Carbon Dioxide - L3K Assay." While it indicates the device is substantially equivalent to a legally marketed predicate device, it does not detail the specific performance acceptance criteria or the study data used to demonstrate its performance. The document only states the "Indications for Use" and general information about regulatory compliance.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for the test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study details or effect size.
6. Standalone algorithm performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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