# K231927: Elecsys PTH , Elecsys PTH STAT

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Mar 22, 2024 after 266 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: 3 generations back to K954418 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070709: Roche Elecsys PTH Test System, Roche Diagnostics Corp. (2007) Summary page 4.

## Indications for use
Immunoassay for the in vitro quantitative determination of intact parathyroid hormone in human serum and plasma for the differential diagnosis of hypercalcemia and hypocalcemia. This assay can be used intraoperatively. The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers

Source page: https://510kreport.com/device/K231927
Methodology: https://510kreport.com/methodology