# K244042: Calcium2

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Ireland
- Decided: Feb 10, 2025 after 42 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: 3 generations back to K850281 (1985). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062855: Calcium, Abbott Laboratories (2006) Summary page 6.

## Indications for use
The Calcium2 assay is used for the quantitation of calcium in human serum, plasma, or urine on the ARCHITECT c System. 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/K244042
Methodology: https://510kreport.com/methodology