# K112788: Eastlyte NA/K/CA/PH

- Pathway: 510(k) (Special)
- Applicant: Medica Corp.
- Decided: Oct 20, 2011 after 24 days
- Product code: CEM (Electrode, Ion Specific, Potassium)
- Device class: 2
- Regulation: 21 CFR 862.1600
- 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 Na/K/Ca/pH analyzer is used for the in-vitro diagnostic testing of Sodium(Na±), Potassium(K±), and ionized Calcium(CaI+) With pH correction in clinical laboratories by trained technicians. Sodium test The sodium (Na+) assay is intended to measure sodium in serum, plasma, and whole blood. 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 dilate 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, and whole blood. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. Calcium-ionized test The ionized calcium (Ca++) assay is intended to measure the ionized calcium level in serum, plasma, and whole blood. Ionized calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.(intermnittent muscular contractions or spasms). Acidosis (low pH) causes increase and alkalosis (high pH) a decrease in the amount of ionized calcium. pH test The sample pH assay is intended to measure the pH- of the sample used in the ionized calcium assay. Measurements of pH are used to calculate the "normalized ionized calcium value" in samples with pI I other than 7.40 units.

Source page: https://510kreport.com/device/K112788
Methodology: https://510kreport.com/methodology