# K964635: Nichols Advantage Chemiluminescence Calcitonin Kit

- Pathway: 510(k) (Traditional)
- Applicant: Nichols Institute Diagnostics
- Decided: May 21, 1997 after 183 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
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K023304: Immulite/Immulite 1000 Calcitonin, Model LKCL and Immulite 2000 Calcitonin, Model L2KCL (2002), 3 descendants of its own
- K132828: Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3 (2013), 2 descendants of its own
- K252431: Elecsys Calcitonin (2026), 0 descendants of its own
- K182012: ADVIA Centaur Calcitonin (CALCT) assay (2018), 0 descendants of its own

Source page: https://510kreport.com/device/K964635
Methodology: https://510kreport.com/methodology