# K182012: ADVIA Centaur Calcitonin (CALCT) assay

- Pathway: 510(k) (Traditional)
- Applicant: Axis-Shield Diagnostics Limited
- Decided: Dec 21, 2018 after 147 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 ADVIA Centaur® Calcitonin (CALCT) assay is for in vitro diagnostic use in the quantitative measurement of calcitonin in human serum using the ADVIA Centaur XP system. Calcitonin measurement is used as an aid in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism.

Source page: https://510kreport.com/device/K182012
Methodology: https://510kreport.com/methodology