# K070391: Elecsys PTH Test System

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Mar 20, 2007 after 39 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.
No later device cites it as a predicate yet.
0 of 3 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.

## Indications for use
Elecsys PTH Immunoassay (18 minute application) Elecsys PTH STAT Immunoassay (9 minute application) Inmunoassay for the in vitro quantitative determination of intact parathyroid hormone in human serum and plasma for the differential diagnosis of hypercalcemia and hypocalcemia. The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers. Elecsys PTH STAT CalSet Elecsys PTH CalSet STAT is used for calibrating the quantitative Elecsys PTH STAT assay for intact PTH (parathyroid hormone) on the Elecsys and cobas e immunoassay analyzers. Elecsys PTH CalSet Elecsys PTH CalSet is used for calibrating the quantitative Elecsys PTH assay for intact PTH (parathyroid hormone) on the Elecsys and cobas e immunoassay analyzers

Source page: https://510kreport.com/device/K070391
Methodology: https://510kreport.com/methodology