(229 days)
The EasyStat pH, PCO2, PO2, Htc, Na, K, Ca/Cl analyzer is designed for clinical laboratory use, making direct measurements of pH (hydrogen ion activity), PCO2 (partial pressure of carbon dioxide), PO2 (partial pressure of oxygen), Htc (Hematocrit), Na * (sodium ions), K (potassium ions), Ca * (ionized calcium) and CI (chloride ions) in whole blood samples from syringes or capillary tubes.
pH measurements are used in the diagnosis and treatment of diseases involving imbalance in the acidbase equilibrium in blood.
PCO2 measurements are used in the diagnosis and treatment of diseases involving imbalance in the partial pressure of carbon dioxide in blood.
PO2 measurements are used in the diagnosis and treatment of diseases conditions characterized by low or high blood oxygen levels in blood.
Hematotric (Htc) measurements are used in the diagnosis and treatment of diseases characterized by erythrocyte imbalances in whole blood.
Sodium measurements are used in the diagnosis and treatment diseases involving electrolyte imbalance.
Potassium measurements monitor electrolyte balance and in the diagnosis and freatment of diseases conditions characterized by low or high blood potassium levels.
Calcium (ionized) measurements are used to determine the physiologically active form of calcium in blood and establish the patient's calcium metabolism.
Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders.
Not Found
I am sorry, but based on the provided text, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for the EasyStat pH, PCO2, PO2, Htc, Na, K, Ca/Cl Analyzer, and it primarily focuses on the substantial equivalence determination and the device's indications for use. It does not contain details about:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers' improvement with AI vs. without AI assistance. (This device is for in-vitro diagnostic analysis of blood, not an AI-assisted diagnostic imaging device).
- If a standalone (algorithm only) performance study was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
§ 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.