# K133601: Advia Centaur Intact Parathyroid Hormone (Ipth) Assay

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Feb 5, 2014 after 72 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: 4 generations back to K954418 (1995). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121981: Advia Centaur Inact Parathyroid Hormone (Ipth) Assay, Siemens Healthcare Diagnostics (2013) Summary page 1.

## Most influential descendants
- K163658: ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay (2017), 0 descendants of its own

## Indications for use
The ADVIA® Centaur Intact Parathyroid (iPTH) assay is for in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH) in EDTA plasma or serum using the ADVIA Centaur and ADVIA Centaur XP systems. This assay is intended to be used to aid in the differential diagnosis of hyperparathyroidism and hypoparathyroidism.

Source page: https://510kreport.com/device/K133601
Methodology: https://510kreport.com/methodology