# K120626: Eon Calcium Regent

- Pathway: 510(k) (Traditional)
- Applicant: Vital Diagnostics (Manufacturing) Ptyltd
- Decided: Aug 22, 2012 after 174 days
- Product code: CJY (Azo Dye, Calcium)
- Device class: 2
- Regulation: 21 CFR 862.1145
- Recalls of this device: 2 (0 Class I)
- 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.

## Recalls of this device
- Aug 29, 2013 · Class II · Z-0732-2014: High positive calcium bias on plasma sample versus results on serum
- Aug 29, 2013 · Class II · Z-0733-2014: High positive calcium bias on plasma sample versus results on serum

## Indications for use
Vital Diagnostics Eon Calcium Reagent is a device intended to measure the total calcium level in serum and plasma using the Eon 100 Analyzer. 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/K120626
Methodology: https://510kreport.com/methodology