# K981578: CA

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jun 16, 1998 after 43 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: 1 generation back to K850281 (1985). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K850281: Calcium, Boehringer Mannheim Corp. (1985) Summary page 1.

## Most influential descendants
- K062855: Calcium (2006), 1 descendant of its own
- K244042: Calcium2 (2025), 0 descendants of its own

## Indications for use
The Calcium assay is used for the quantitation of calcium in human serum, plasma, or urine. 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/K981578
Methodology: https://510kreport.com/methodology