(67 days)
The EasyStat analyzer is designed for clinical laboratory use, making direct measurements of pH (hydrogen ion activity), PCO2 (partial pressure of carbon dioxide), PQ2 (partial pressure of oxygen),Hct (Hematocrit), Na* (sodium), K' (potassium), and Ca* (ionized calcium) on whole blood samples from syringes or capillary tubes.
This analyzer is used by laboratory trained technicians in the clinical laboratories to aide in the diagnosis and treatment of patients with electrolyte, blood gas and/or acid base disturbances. The patient results obtained from the EasyStat analyzer must be used in conjunction with the overall patient clinical condition before corrective / therapeutic action is taken.
Not Found
This document is a 510(k) clearance letter from the FDA for the EasyStat pH, PCO2, PO2, Hct, Na+, K+, Ca++ Analyzer. It does not contain the acceptance criteria or a study proving the device meets those criteria. Such information would typically be found in the 510(k) submission itself, which is not publicly available in this FDA letter.
Therefore, I cannot provide the requested information based on the provided text.
§ 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.