# K163658: ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: May 23, 2017 after 151 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
Longest line of descent: 5 generations back to K954418 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133601: Advia Centaur Intact Parathyroid Hormone (Ipth) Assay, Siemens Healthcare Diagnostics, Inc. (2014) Summary page 4.

## Indications for use
The ADVIA Centaur® Intact Parathyroid Hormone (PTH) assay is for in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (PTH) in human serum and plasma using the ADVIA Centaur XP system. This assay is intended to be used to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or disorders of calcium metabolism. This assay can be used intra-operatively.

Source page: https://510kreport.com/device/K163658
Methodology: https://510kreport.com/methodology