# K990971: Easylyte Quality Control Kit, Models 2814, 2815, 2816

- Pathway: 510(k) (Traditional)
- Applicant: Medica Corp.
- Decided: Apr 27, 1999 after 35 days
- Product code: JJR (Electrolyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- 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 assayed EasyLyte Quality Control Kit is intended for use with IVD electrolyte analyzers to estimate test imprecision and to detect systematic analytical deviations that may occur because of instrument or reagent variation.

Source page: https://510kreport.com/device/K990971
Methodology: https://510kreport.com/methodology