# K113216: Rapidpoint 500 Blood Gas Analyer

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: May 3, 2012 after 184 days
- Product code: KHP (Acid, Lactic, Enzymatic Method)
- Device class: 1
- Regulation: 21 CFR 862.1450
- Recalls of this device: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K946206 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031560: Bayer Rapidlab 1200 System, Bayer Healthcare, LLC (2003) Summary page 1.
- (no number) RAPIDLab 1265: named in the summary without a submission number

## Recalls of this device
- Sep 26, 2023 · Class II · Z-0423-2024: 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
- Apr 10, 2017 · Class II · Z-2040-2017: Potential Patient Demographic Error with Blank Patient ID Field
- Aug 11, 2016 · Class II · Z-2799-2016: There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system
- Jul 5, 2016 · Class III · Z-2601-2016: Some v2.2.2 upgrade kits include a dialysate mode which not cleared/approved for shipment in the United States
- Aug 24, 2015 · Class II · Z-2813-2015: RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results
- Aug 24, 2015 · Class II · Z-2816-2015: RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results
- Aug 24, 2015 · Class II · Z-2814-2015: RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results
- Aug 24, 2015 · Class II · Z-2815-2015: RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results
- Jul 28, 2015 · Class II · Z-2479-2015: When both ports (Serial and Ethernet) are configured to transmit data, the data stream from one port could potentially affect the data stream from the other port causing the data management system to 
- Dec 30, 2014 · Class II · Z-1253-2015: Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration is greater than 12 mg/dl and the tHb concentration exceeds the upper reportable range of greater than 2
- May 23, 2014 · Class II · Z-2079-2014: RAPIDPoint 500 Measurement Cartridges may have an error code one or more electrolyte parameters (e.g., Na+, Ca++, K+, Cl-)
- Sep 17, 2012 · Class II · Z-0104-2014: RAPIDPoint 400 Series, RAPIDPoint 500, or RAPIDLab 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misiden

## Indications for use
The RAPIDPoint 500 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 * Total hemoglobin and fractions: fO2Hb, fCOHb, fMetHb, fHHb * Neonatal bilirubin * Lactate 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 500 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). PCO 2, P0 2, 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. Sulfhemoglobin. Sulfhemoglobin measurements are used to determine the sulfhemoglobin (a compound of sulfur and hemoglobin) content of human blood as an aid in the diagnosis of sulfhemoglobinemia (presence of sulfhemoglobin in the blood due to drug administration or exposure to a poison).

Source page: https://510kreport.com/device/K113216
Methodology: https://510kreport.com/methodology