# K152327: EasyLyte Na/K/Cl/Ca Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Medica Corporation
- Decided: Dec 1, 2016 after 471 days
- Product code: JFP (Electrode, Ion Specific, Calcium)
- Device class: 2
- Regulation: 21 CFR 862.1145
- 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/Cl/Ca Analyzer is intended for in-vitro diagnostic testing of sodium (Na), Potassium (K), Chloride (CL), and lonized Calcium (Ca++) without pH correction. The ionized calcium test on the EasyLyte Na/K/Cl/Ca analyzer is intended for the quantitative determination of calcium ions (Ca++) in human serum, plasma and whole Blood in clinical laboratories. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Source page: https://510kreport.com/device/K152327
Methodology: https://510kreport.com/methodology