# K051810: Whole PTH (1-84) Specific Immunoradiometric Assay (Irma) Coated Tube Kit, Model 3KG014

- Pathway: 510(k) (Traditional)
- Applicant: Scantibodies Laboratory, Inc.
- Decided: Sep 9, 2005 after 66 days
- Product code: CEW (Radioimmunoassay, Parathyroid Hormone)
- Device class: 2
- Regulation: 21 CFR 862.1545
- 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. Whole Parathyroid Hormone (PTH) test system is a device intended to measure parathyroid hormone in plasma and serum. PTH measurements are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.

Source page: https://510kreport.com/device/K051810
Methodology: https://510kreport.com/methodology