# K192240: RAPIDPoint 500e Blood Gas System - Pathway: 510(k) (Special) - Applicant: Siemens Healthcare Diagnostics, Inc. - Decided: Mar 27, 2020 after 221 days - Product code: CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph) - Device class: 2 - Regulation: 21 CFR 862.1120 - Recalls of this device: 4 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 4 generations back to K872888 (1987). 5 ancestors in all. 3 later devices descend from it; 2 cite it directly. 0 of 9 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K122539: Measurement of PH in Pleural Fluid on Blood Gas System, Siemens Healthcare Diagnostics (2013) Summary page 10. ## Most influential descendants - K223857: i-STAT G3+ cartridge with the i-STAT 1 System (2023), 1 descendant of its own - K244014: i-STAT CG4+ cartridge with the i-STAT 1 System (2025), 0 descendants of its own - K230285: i-STAT CG8+ cartridge with the i-STAT 1 System (2023), 0 descendants of its own ## Recalls of this device - May 17, 2024 · Class II · Z-2214-2024: Siemens Healthineers has identified an issue with the RAPIDPoint500e system software version 5.3. This issue affects how the sample source is identified at the LIS when using the capillary mode. With - Sep 26, 2023 · Class II · Z-0422-2024: There are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that may cause falsely elevated sodium results reported on the RAPIDPoint 500 and RAPIDPoint 500e Blood Gas - Jun 1, 2022 · Class II · Z-1372-2022: Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support. - May 27, 2020 · Class II · Z-2432-2020: The scanner is not confirming the integrity of read barcode data using the check-digit when reading Code 39 barcodes. ## Indications for use The RAPIDPoint® 500e Blood Gas System is intended for in vitro diagnostic use and is designed to provide the determination in whole blood for the following parameters: • Partial pressure of carbon dioxide • Partial pressure of oxygen • pH • Sodium • Potassium • Ionized Calcium • Chloride • Glucose • Lactate • Total Hemoglobin and fractions: FO2Hb, FCOHb, FMetHb, FHHb • Neonatal Bilirubin The RAPIDPoint 500e Blood Gas System is also intended for in vitro testing of pleural fluid samples for the pH parameter. The pH measurement of pleural fluid can be a clinically useful tool in the management of patients with parapneumonic effusions. The following critical value applies to pleural fluid pH: pH > 7.3 is measured in uncomplicated parapneumonic effusions. All pleural fluids with a pH measurement < 7.3 are referred to as complicated parapneumonic effusions and are exudative in nature. This test system is intended for use in point of care or laboratory settings. The following list includes the Indications for Use information for each analyte measured on the RAPIDPoint 500e Blood Gas System: Lactate: A lactic acid test system is a device intended to measure lactic acid in whole blood. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood). Neonate Bilirubin: A bilirubin (total and unbound) in the neonate test system is a device intended to measure the levels of bilirubin (total and unbound) in the blood (serum) of newborn infants to aid in indicating the risk of bilirubin encephalopathy (kernicterus). pCO2, p02, pH: Measurements of blood gases (pCO2, p02) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances. Sodium: Sodium measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Potassium: Potassium measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. Chloride: Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. Ionized calcium: Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). Glucose: Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. Total hemoglobin: Total hemoglobin measurements are used to determine the hemoglobin content of human blood. Oxyhemoglobin: Oxyhemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia. Carboxyhemoglobin: Carboxyhemoglobin measurements are used to determine the carboxyhemoglobin (the compound formed when hemoglobin is exposed to carbon monoxide) content of human blood as an aid in the diagnosis of carbon monoxide poisoning. Source page: https://510kreport.com/device/K192240 Methodology: https://510kreport.com/methodology