# K113131: Liasys 450

- Pathway: 510(k) (Traditional)
- Applicant: Ams
- Decided: Mar 8, 2012 after 136 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 450 SAT 450' is a random access, computer controlled, counter top, clinical analyzer for clinical chemistry. The instrument provides in vitro quantitative measurements for glucose, sodium, potassium and chloride in serum. Qther various chemistry assays are adaptable to this instrument. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemnia and idiopathic hypoglytemnia and of pancreatic islet cell carcinoma. 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/K113131
Methodology: https://510kreport.com/methodology