# K151113: ELITech Clinical Systems CALCIUM ARSENAZO

- Pathway: 510(k) (Traditional)
- Applicant: Elitechgroup
- Decided: Jul 22, 2015 after 86 days
- Product code: CJY (Azo Dye, 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
Longest line of descent: 5 generations back to K933930 (1994). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123171: Abx Pentra Calcium as CP, Abx Pentra Urine Control L/H, Abx Pentra Multical, Abx Pentra N Control, and Abx Pentra P Cont, Horiba Abx Sas (2013) Summary page 4.

## Indications for use
ELITech Clinical Systems CALCIUM ARSENAZO is intended for the quantitative in vitro diagnostic determination of total calcium in human serum, plasma and urine using ELITech Clinical Systems Selectra Pro Series Analyzers. It is not intended for use in Point of Care settings. 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/K151113
Methodology: https://510kreport.com/methodology