# K121981: Advia Centaur Inact Parathyroid Hormone (Ipth) Assay

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Mar 21, 2013 after 258 days
- Product code: CEW (Radioimmunoassay, Parathyroid Hormone)
- Device class: 2
- Regulation: 21 CFR 862.1545
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K954418 (1995). 3 ancestors in all.
2 later devices descend 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)
- K063232: Architect Intact PTH Reagents, Calibrators (a-F) and Controls (Low, Medium, High), Models 8K25-20, 8K25-25, 8K25-01, Biokit, S.A. (2007) Summary page 1.

## Most influential descendants
- K133601: Advia Centaur Intact Parathyroid Hormone (Ipth) Assay (2014), 1 descendant of its own
- K163658: ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay (2017), 0 descendants of its own

## Recalls of this device
- May 14, 2013 · Class II · Z-1513-2013: iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability
- May 14, 2013 · Class II · Z-1512-2013: iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability

## 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 XP system. This assay is intended to be used to aid in the differential diagnosis of hyperparathyroidism and hypoparathyroidism.

Source page: https://510kreport.com/device/K121981
Methodology: https://510kreport.com/methodology