# K252431: Elecsys Calcitonin

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics GmbH
- Decided: Apr 24, 2026 after 266 days
- Product code: JKR (Radioimmunoassay, Calcitonin)
- Device class: 2
- Regulation: 21 CFR 862.1140
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K931172 (1993). 47 ancestors in all.
No later device cites it as a predicate yet.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132828: Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3, Roche Diagnostics (2013) Summary page 5.

## Indications for use
The Calcitonin immunoassay is intended for the in vitro quantitative determination of human calcitonin (thyrocalcitonin) in serum and plasma. The calcitonin determination is intended to be used as an aid in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism in conjunction with other clinical and laboratory findings. The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K252431
Methodology: https://510kreport.com/methodology