(118 days)
For the quantitative determination of carbon dioxide in serum and plasma. For IN VITRO diagnostic use.
The DCL Carbon Dioxide L3K® assay is an enzymatic procedure, employing phosphoenolpyruvate carboxylase (PEPC) (2) and a stabilized NADH analog (3), which is easy to use and applicable to routine laboratory instrumentation.
I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a Carbon Dioxide-L3K Assay. It confirms the substantial equivalence of the device to legally marketed predicate devices and outlines regulatory requirements.
This document does not contain information about:
- Acceptance criteria and reported device performance in a table format.
- Sample sizes, data provenance, or details about test sets.
- Number and qualifications of experts for ground truth establishment.
- Adjudication methods.
- Results of multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set or how ground truth for the training set was established.
Therefore, I cannot fulfill your request based on the provided input.
§ 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.