Blood gas testing is used to measure the levels of oxygen (PO2), carbon dioxide (PCO2), and blood pH, among other important indicators. These tests are typically performed to evaluate a person’s respiratory function, acid-base balance, and metabolic state. They are important in diagnosing and managing conditions like respiratory failure, kidney disease, and metabolic imbalances

A blood gas (PCO2, PO2) and blood pH test system are 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

Intended use: It is designed for clinical laboratory use, making quantitative measurements of pO2 (partial pressure of oxygen), pCO2 (partial pressure of carbon dioxide), and pH (hydrogen ion activity) in whole blood (arterial/venous) samples from Li-Heparinized Syringes or Capillary Tubes. This Analyzer should only be used by trained technicians in clinical laboratories to aid in the diagnosis and treatment of patients with blood gas and/or acid-base disturbance

Device description: The device is a blood gas analyzer designed for in vitro quantification of pH, partial pressure of oxygen (P02), and partial pressure of carbon dioxide (PC02) in whole blood samples, typically collected from arterial, venous, or capillary sources. It is intended for use in point-of-care or clinical laboratory settings to assist healthcare professionals in the diagnosis, monitoring, and treatment of respiratory, metabolic, and acid-base disturbances. The system consists of several key components: a blood sample collection chamber, sensors for pH, P02, and PC02 measurements, a microprocessor for data analysis, and a display or output system for result presentation. The device operates by passing the blood sample through electrochemical sensors, which measure the concentration of gases and pH levels in the sample. The sensors generate signals that are processed by the microprocessor, which then converts them into readable values of pH, P02, and PC02. These results are displayed in real-time, allowing clinicians to quickly assess and make informed decisions about a patient’s condition. Additionally, the system may include a user interface for calibration, maintenance, and data storage, and some models may offer connectivity features for integration with electronic health records (EHR) systems for better tracking of patient data. This rapid and accurate measurement of blood gases is critical for managing patients with conditions such as respiratory failure, metabolic disorders, and acid-base imbalances.

• Precision/Reproducibility
• Linearity/assay reportable range
• Detection Limit
• Analytical Specificity

The same is applicable for CE Marking under IVDR also.

Not Applicable for 510k submission and IVDR CE Marking