# K070709: Roche Elecsys PTH Test System

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Jul 13, 2007 after 121 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: 2 generations back to K954418 (1995). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992680: Elecsys Parathyroid Hormone Test System, Roche Diagnostics Corp. (1999) Summary page 2.

## Most influential descendants
- K231927: Elecsys PTH , Elecsys PTH STAT (2024), 0 descendants of its own
- K221197: VITROS Immunodiagnostic Products Intact PTH II Reagent Pack (2023), 0 descendants of its own

## Indications for use
The Elecsys PTH: Immunoassay for the in vitro quantitative detennination of intact parathyroid hormone in human serum and plasma for the differential diagnosis of hypercalcemia and hypocalcemia. The Elecsys PTH assay can be used intraoperatively. The Elecsys PTH STAT: Immunoassay for the in vitro quantitative determination of intact parathyroid hormone in human serum and plasma for the differential diagnosis of hypercalcemia and hypocalcemia. The Elecsys PTH STAT assay can be used intraoperatively.

Source page: https://510kreport.com/device/K070709
Methodology: https://510kreport.com/methodology