# K051804: ABL80 Flex Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Sendx Medical, Inc.
- Decided: Nov 1, 2005 after 119 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: 6 generations back to K861087 (1986). 18 ancestors in all.
2 later devices descend from it; 1 cites 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)
- K994346: Abl 77 PH, Blood Gas and Electrolyte Analysis System, Sendx Medical, Inc. (2000) Summary page 2.
- K980130: ABL700 Series Blood Gas , CO-Oximetry, Electrolyte & Metabolite System, Radiometer America, Inc. (1998) Summary page 2.
- K050869: Modification to ABL800 Flex, Radiometer Medical Aps (2005). Cleared while this submission was under review Summary page 2.

## Most influential descendants
- K080370: Abl 80 CO-OX System (2008), 1 descendant of its own
- K151856: ABL80 FLEX CO-OX with AQURE connectivity (2015), 0 descendants of its own

## Recalls of this device
- May 11, 2020 · Class II · Z-2467-2020: Barcode readers on ALB900 and ABL800 analyzers used for measuring pH, blood gases, electrolytes, glucose, lactate, hematocrit and oximetry may misinterpret the contents of some barcode types not using
- Jun 6, 2012 · Class II · Z-2304-2012: The firm recalled because the glucose measurements from a patient sample that the customer felt was too low and did not reflect the patient's clinical condition.
- Jan 30, 2012 · Not classified · Z-1384-2012: The product can cause the analyzer to report values outside the published performance specifications for pH, pCO2, cNa+, cK+, cCa2+ and cCl-.
- Jun 4, 2007 · Not classified · Z-1201-2007: The ABL8O FLEX software version 1.10 contains errors in the derived parameter calculation for cBase(B,ox) and cBase(Ecf,ox). These incorrect calculations result in a mild to moderate lowering of the b

## Indications for use
These tests are only performed under a physicians order: pH: pH is the indispensable measure of acidemia or alkalemia and is therefore an essential part of the pH/Blood gas measurement. p02: The arterial oxygen tension is an indicator of the oxygen uptake in the lungs. pCO 2: pCO 2 is a direct reflection of the adequacy of alveolar ventilation in relation to the metabolic rate. Potassium (cK+): The potassium level is the predominant intracellular cation. It is fundamental for correct neuromuscular activity Sodium (cNa+): The sodium ion is the most abundant cation in plasma. It is the foremost agent involved in maintenance of osmolality and body fluid volumes. Calcium (cCa 2+): The calcium ion is the most abundant mineral element in the human body and is involved in numerous enzymatic processes, blood coagulation, cell growth, and membrane transport mechanisms as well as plays an important role in nervous impulse conduction, neuromuscular transmission, and muscular contraction and relaxation. Chloride (cCl): The chloride ion is the main extracellular anion and plays an important role in maintaining electrical neutrality. Hematocrit (Hct): The hematocrit measurement is the ratio of the volume of red blood cells in whole blood in comparison to the total volume. Glucose (cGlu): The glucose measurements are used to screen for, diagnose and monitor glycemic levels in potential pre-diabetic, diabetic, hypoglycemic patients.

Source page: https://510kreport.com/device/K051804
Methodology: https://510kreport.com/methodology