# K132828: Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Dec 4, 2013 after 86 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: 9 generations back to K931172 (1993). 46 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023304: Immulite/Immulite 1000 Calcitonin, Model LKCL and Immulite 2000 Calcitonin, Model L2KCL, Diagnostic Products Corp. (2002) Summary page 2.
- K113546: Elecsys Vitamin D Assay Elecsys Vitamin D Calset Elecsys Precicontrol Varia 3 Elecsys Vitamin D Calcheck 5, Roche Diagnostics (2012)
- K112528: Elecsys T4 Calcheck 5, Roche Diagnostics Corporation (2011) Summary page 4.
- K111506: Elecsys Precicontrol Varia 3, Roche Diagnostics (2011) Summary page 2.

## Most influential descendants
- K252431: Elecsys Calcitonin (2026), 0 descendants of its own
- K182012: ADVIA Centaur Calcitonin (CALCT) assay (2018), 0 descendants of its own

## 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. Calcitonin CalSet is used for calibrating the quantitative Elecsys Calcitonin assay on the Eiecsys and cobas e inmnunoiassay analyzers. The Eleesys CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the ealcironin assay range established by the Eiecsys and cobas e immunoassay analyzers. The Elccsys PreciControl Varia is used for quality control of the Eleesys inimunoassays on Elecsys and cobas e immunoiassay analyzers.

Source page: https://510kreport.com/device/K132828
Methodology: https://510kreport.com/methodology