# K142898: ABL800 FLEX with AQURE connectivity

- Pathway: 510(k) (Special)
- Applicant: Radiometer Medical Aps
- Decided: Jun 17, 2015 after 254 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: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K861087 (1986). 16 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041874: ABL800 Flex, Radiometer Medical Aps (2004) Summary page 7.

## Most influential descendants
- K160402: GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin) (2016), 2 descendants of its own
- K203790: GEM Premier 5000 (2021), 1 descendant of its own
- K223608: GEM Premier 7000 with IQM3 (2023), 0 descendants of its own

## Recalls of this device
- Feb 27, 2018 · Class II · Z-1582-2018: There is a potential problem relating to the AQURE System, versions 2.3.0 and 2.3.1, that may result in patient mix-up.
- Nov 23, 2016 · Class II · Z-0899-2017: Design error when displaying additional information in the patient view window; error may result in misreading a parameter and its value.
- Dec 29, 2015 · Class II · Z-0748-2016: The AQURE System has a design error regarding sample type in which sample type may be specified for some results and left blank for other results. The fact that the sample type field is left blank in 

## Indications for use
The ABL800 FLEX analyzers are intended for In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF). In addition the ABL800 FLEX is intended for In vitro testing of samples of expired air for the parameters pO2 and pCO2, and for In vitro testing of pleura samples for the pH parameter. pH: pH is the indispensable measure of acidemia or alkalemia and is therefore an essential part of the pH/blood gas measurement. The normal function of many metabolic processes requires a pH to be within a relatively narrow range. pO2: The arterial oxygen tension is an indicator of the oxygen uptake in the lungs. pCO2: pCO2 is a direct reflection of the adequacy of alveolar ventilation in relation to the metabolic rate. Potassium (cK+): the measurements of the concentration of potassium ions in plasma are used to monitor the electrolyte balance. Sodium (cNa+): the measurements of the concentration of sodium ions in plasma are used to monitor the electrolyte balance. Calcium (cCa++): the measurements of the concentration of calcium ions in plasma are used to monitor the electrolyte balance. Chloride (cCl-): the measurements of the concentration of chloride ions in plasma are used to monitor the electrolyte balance. Glucose (cGlu): The glucose measurements measure the concentration of glucose in plasma. The glucose measurements are used to screen for, diagnose and monitor diabetes, pre-diabetes and hyper and hypoglycemia. Lactate (cLac): The lactate measurements measure the concentration of lactate in plasma. Lactate measurements serve as a marker of critical imbalance between tissue oxygen demand and oxygen supply. Bilirubin (ctBil): The bilirubin measurements measure the total concentration of bilirubin in plasma. ctBil is used to assess the risk of hyperbilirubinemia. Total Hemoglobin (ctHb): ctHb is a measure of the potential oxygen-carrying capacity of the blood. Oxygen Saturation (sO2): sO2 is the percentage of oxygenated hemoglobin in relation to the amount of hemoglobin capable of carrying oxygen. sO2 allows evaluation of oxygenation. Fraction of Oxyhemoglobin (FO2Hb): FO2Hb is a measure of the utilization of the potential oxygen transport capacity; that is the fraction of oxyhemoglobin in relation to all hemoglobins present (tHb) including dyshemoglobins. Fraction of Carboxyhemoglobin (FCOHb): FCOHb is the fraction of carboxyhemoglobin. It is incapable of transporting oxygen. Fraction of Methemoglobin (FMetHb): FMetHb is the fraction of methemoglobin. It is incapable of transporting oxygen. Fraction of Deoxyhemoglobin in Total Hemoglobin (FHHb): FHHb is the fraction of deoxyhemoglobin in total hemoglobin. It can bind oxygen then forming oxyhemoglobin. Fraction of Fetal Hemoglobin (FHbF): Fetal hemoglobin consist of two α-chains and two β-chains, and has a higher oxygen affinity than adult Hb. Creatinine (cCrea): The creatinine measurements measure the concentration of creatinine in blood. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis. Pleural pH: The pH measurement of pleural fluid can be a clinically useful tool in the management of patients with parapneumonic effusions. Critical values: pH >7.3 is measured in uncomplicated parapneumonic effusions. All pleural effusions with a pH of <7.3 are referred as complicated parapneumonic effusions; they are exudative in nature.

Source page: https://510kreport.com/device/K142898
Methodology: https://510kreport.com/methodology