# K100673: Easylyte NA/K/CL/LI Analyzer, Model  2020

- Pathway: 510(k) (Special)
- Applicant: Medica Corp.
- Decided: Apr 6, 2010 after 28 days
- Product code: JGS (Electrode, Ion Specific, Sodium)
- Device class: 2
- Regulation: 21 CFR 862.1665
- 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 EasyLyte analyzers are used for the in-vitro diagnostic testing of Sodium (Na+), Potassium (K+), chloride (Cl-), and Lithium (Li) in clinical laboratories by trained technicians. Sodium test The sodium (Na+) assay is intended to measure sodium in serum, plasma, whole blood and urine. Sodium measurements 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 test The potassium (K+) assay is intended to measure potassium in serum, plasma, whole blood and urine. Po'tassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by 16w or high blood potassium levels. Chloride test The chloride (Cl-) assay is intended to measure the level of chloride in plasma, serum, whole blood, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. Lithium test The lithium (Li+) assay is intended to measure lithium (from the drug lithium carbonate) in serum, plasma and whole blood. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).

Source page: https://510kreport.com/device/K100673
Methodology: https://510kreport.com/methodology