(65 days)
The EasyBloodGas analyzer is designed for laboratory use, making direct measurements of pH (hydrogen ion activity), PCO2 (partial pressure of carbon dioxide) and PO2 (partial pressure of oxygen) on whole blood samples from syringes or capillary tubes.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the "Easy Blood Gas Analyzer." It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain specific information regarding acceptance criteria, study details (like sample sizes, ground truth establishment, or expert qualifications), or performance results from a study.
Therefore, I cannot fulfill your request for the detailed table and study description based solely on the provided text. The document confirms the device's clearance for marketing but does not delve into the technical validation study results that would typically be found in the 510(k) submission itself (which is not provided here).
§ 862.1120 Blood gases (P
CO2 , PO2 ) and blood pH test system.(a)
Identification. A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.(b)
Classification. Class II.