# K060578: Calcitonin Immunoradiometric Assay (Irma) (Coated Tube Version)

- Pathway: 510(k) (Traditional)
- Applicant: Scantibodies Laboratory, Inc.
- Decided: Aug 30, 2006 after 177 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Scantibodies Laboratory Inc. Calcitonin test system is a device intended to measure the thyroid hormone calcitonin (thryocalcitonin) levels in serum. Calcitonin measurements are used in the diagnosis and treatment of diseases involving the thyroid and parathyroid glands, including carcinoma and hyperparathyroidism (excessive activity of the parathyroid gland).

Source page: https://510kreport.com/device/K060578
Methodology: https://510kreport.com/methodology