# K060348: Modification to: Total Intact PTH Immunochemiluminometric (Icma) Assay Kit

- Pathway: 510(k) (Special)
- Applicant: Scantibodies Laboratory, Inc.
- Decided: Feb 27, 2006 after 17 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. The FDA summary names no predicate by number.

## Indications for use
The Scantibodies Laboratory, Inc. Total Intact Parathyroid Hormone (PTH) test system is a device intended to measure parathyroid hormone in plasma. Measurements of parathyroid hormone levels 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/K060348
Methodology: https://510kreport.com/methodology