# K123748: ABL90 Flex

- Pathway: 510(k) (Special)
- Applicant: Radiometer Medical Aps
- Decided: May 7, 2013 after 152 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K861087 (1986). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111897: ABL90, Radiometer Medical Aps (2011) Summary page 2.

## Indications for use
The ABL90 FLEX analyzer is a portable, automated analyzdr that measures pH, blood gases, electrolytes, glucose, lactate, and oximetry in beparinised whole blood. The ABL90 FLEX analyzer is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting. These tests are only performed under a physician's order. pH,p0 2 andpCO 2 : pH,PCO2 andPO 2 measurements are used in the diagnosis and treatment of life-threatening acid-base disturbances. Potassium (cWt: potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Sodium (cNat): sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration,inappropriate antidiuretic secretion, or other diseases involving electrolyte-imbalance. Calcium (cCa 2 4) calcium measurements are used in the diagnosis and treatment of. parathyroid disease, a variety of bone diseases, chronic renal disease and tetany. Chloride (cCfl: chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such a cystic fibrosis and diabetic acidosis. Glucose (cGlu): glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. Lactate (cLac): The lactate measurements measure the concentration of lactate in plasma. Lactate measurements are used to evaluate the acid-base status and are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood.) Total Hemoglobin (ctffb): total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia. S0 2 : oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus reduced hemoglobin. FOjlb: oxyhemoglobin as a fraction of total hemoglobin. FCOHb: carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning. FMetllb: methemoglobin as a fraction of total hemoglobin. FHflb: reduced hemoglobin as a fraction of total hemoglobin. Fraction of Fetal Hemoglobin (FHbF): FHbF indicates the amount of fetal hemoglobin. F-HbF is seldom used clinically.

Source page: https://510kreport.com/device/K123748
Methodology: https://510kreport.com/methodology