# K100060: Eon 100 Chemistry Analyzer with Ise , Model 77105, Bicarbonate Reagent, Model 77475

- Pathway: 510(k) (Traditional)
- Applicant: Vital Diagnostics (Manufacturing) Ptyltd
- Decided: Dec 15, 2010 after 338 days
- Product code: KHS (Enzymatic, Carbon-Dioxide)
- Device class: 2
- Regulation: 21 CFR 862.1160
- 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 Eon 100 is a discrete photometric chemistry analyzer for clinical use. It is a device intended for the in-vitro, spectrophotometric determination of general chemistry assays. The Eon 100 has replaceable parts, automated maintenance monitoring and backup of both patient and system data. The Eon 100 Chemistry Analyzer is intended to be used to assist the clinician with the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease. The Eon 100 includes an optional Ion Selective Electrodes (ISE) module for the measurement of sodium, potassium and chloride in serum and plasma. The Eon 100 is for in vitro diagnostic use only. An amylase test system is a device intended to measure the quantitative activity of the enzyme amylase in serum and plasma on the EON 100 Chemistry Analyzer. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas). An albumin test system is a device intended to quantitatively measure the albumin concentration in serum and plasma on the EON 100 Chemistry Analyzer. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. A bicarbonate/carbon dioxide test system is a device intended to quantitatively measure bicarbonate/carbon dioxide in serum and plasma on the EON 100 Chemistry Analyzer. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. Sodium A sodium test system is a device intended to quantitatively measure sodium in serum and plasma on the EON 100 Chemistry Analyzer. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Potassium A potassium test system is a device intended to quantitatively measure potassium in serum and plasma on the EON 100 Chemistry Analyzer. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. Chloride A chloride test system is a device intended to quantitatively measure the level of chloride in serum and plasma on the EON 100 Chemistry Analyzer. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis A Total protein test system is a device intended to quantitatively measure total protein(s) in serum and plasma on the EON 100 Chemistry Analyzer. Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders. A Uric acid test system is a device intended to quantitatively measure uric acid in serum and plasma on the EON 100 Chemistry Analyzer. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs. The Eon Calbrator Kit is a device intended for medical purposes for use in a test system to establish points of reference for albumin, total protein, and uric acid on the EON 100 Chemistry Analyzer that are used in the determination of values in the measurement of substances in human specimens. The Eon Carbon Dioxide Calibrator is a device intended for medical purposes for use in the Eon Carbon Dioxide Reagent assay on the EON 100 Chemistry Analyzer to establish points of reference that are used in the determination of values in the measurement of carbon dioxide in serum and plasma.

Source page: https://510kreport.com/device/K100060
Methodology: https://510kreport.com/methodology