# K080468: Liasys with Models Liasys

- Pathway: 510(k) (Traditional)
- Applicant: Ams S.R.L. Analyzer Medical System
- Decided: Jul 25, 2008 after 155 days
- Product code: CFR (Hexokinase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The "Liasys" is a random access, computer controlled, counter top, clinical analyzer for clinical chemistry. The instrument provides the In Vitro diagnostic quantitative measurements for glucose, urea nitrogen, creatinine and AST in serum, and for sodium, potassium and chloride in serum. Other various chemistry assays may be adaptable to this instrument. 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. Urea Nitrogen measurements are use in the diagnosis and treatment of certain renal and metabolic diseases. Measurements of Creatinine are used in the diagnosis and treatment of muscle diseases and endocrine disorders. Aspartate amino transferase (AST) quantitative measurements are used in the diagnosis and treatment of certain types of liver and heart disease. Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus and other diseases involving electrolyte imbalance. Measurements of Potassium are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

Source page: https://510kreport.com/device/K080468
Methodology: https://510kreport.com/methodology