# K043218: ABL800 Flex with Flexq Module, Model ABL8XX

- Pathway: 510(k) (Traditional)
- Applicant: Radiometer Medical Aps
- Decided: May 10, 2005 after 169 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.
4 later devices descend from it; 3 cite it directly.
0 of 21 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 1.
- K972673: Avl 9181 Electrolyte Analyzer, Avl Scientific Corp. (1997) Summary page 1.

## Most influential descendants
- K073537: Neonatal Bilirubin on Rapidlab Models 1245 and 1265 (2008), 1 descendant of its own
- K151639: ABL80 FLEX and ABL80 FLEX CO-OX (2015), 0 descendants of its own
- K110277: Rapidpoint 405 Neonatal Bilirubin (2011), 0 descendants of its own
- K051968: ABL8X7 Flex (2006), 0 descendants of its own

## Recalls of this device
- Oct 8, 2012 · Class II · Z-2303-2013: RADIOMETER became aware that some membranes may have enzyme residue on the outer membrane. The enzyme residue may cause an initial negative bias on the reported Lactate result upon replacement of the 
- Apr 7, 2011 · Not classified · Z-2571-2011: Based on internal testing and user/customer complaint reports received, the firm determined that wrinkles may arise on the outer membrane of the calcium membrane units upon installation. Retention of 
- Jan 16, 2007 · Not classified · Z-0705-2007: In some situations pre-registered patient data is not reset when leaving the pre-registration mode in the software. This occurs when a Safe Pico blood sampler associated with a specific patient is pre

## Indications for use
The ABL800 FLEX with FLEXQ Module is intended for in vitro testing of samples of whole blood for the parameters pH, P0 2, pCO 2, potassium, sodium, calcium, chloride, glucose, lactate, total bilirubin, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) as well as for in vitro testing of samples of expired air for the parameters PO2 and pCO 2. Indication for use information for the analytes measured by the ABL800 FLEX: 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. PC0 2: pCO 2 is a direct reflection of the adequacy of alveolar ventilation in relation to the metabolic rate. Potassium (cK4): 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 2 l): The measurements of the concentration of calcium ions in plasma are used to monitor the electrolyte balance. Chloride (cClj: 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. Blifrubin (ctBiI): 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 (sO 2): 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): FCOI-b 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 consists of two a-chains and two P-chains, and has a higher oxygen affinity than adult Hb.

Source page: https://510kreport.com/device/K043218
Methodology: https://510kreport.com/methodology