(94 days)
This product is to be used for the quantitative determination of carbon dioxide in human serum by spectrophotometric analysis. The determination of the level of carbon dioxide in serum is commonly performed as an indicator of acid-base balance disturbances.
Carbon Dioxide Liquid Stable Reagent
I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving a device meets acceptance criteria, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details.
The text is a regulatory clearance letter from the FDA for a medical device called "Carbon Dioxide Liquid Stable Reagent." It states that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements for marketing. It does not contain any performance study data or details about criteria for such a study.
§ 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.