# K992680: Elecsys Parathyroid Hormone Test System

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Sep 28, 1999 after 49 days
- Product code: CEW (Radioimmunoassay, Parathyroid Hormone)
- Device class: 2
- Regulation: 21 CFR 862.1545
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K954418 (1995). 1 ancestor in all.
11 later devices descend from it; 5 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954418: Intact Parathyroid Hormone (PTH) Immunoassay (Modification), Nichols Institute Diagnostics (1995) Summary page 1.

## Most influential descendants
- K063232: Architect Intact PTH Reagents, Calibrators (a-F) and Controls (Low, Medium, High), Models 8K25-20, 8K25-25, 8K25-01 (2007), 3 descendants of its own
- K121981: Advia Centaur Inact Parathyroid Hormone (Ipth) Assay (2013), 2 descendants of its own
- K070709: Roche Elecsys PTH Test System (2007), 2 descendants of its own
- K133601: Advia Centaur Intact Parathyroid Hormone (Ipth) Assay (2014), 1 descendant of its own
- K061190: Access Intact PTH and Calibrators, Models a 16972 and a 16953 (2006), 1 descendant of its own

## Recalls of this device
- Apr 19, 2007 · Not classified · Z-0810-2007: Negative bias caused by hemolysis interference at the low end of the reference range could cause erroneous diagnosis of hypoparathyroidism.

## Indications for use
For the in vitro quantitative determination of intact parathyroid hormone in human serum and plasma for the differential diagnosis of hypercalcemia and hypocalcemia.

Source page: https://510kreport.com/device/K992680
Methodology: https://510kreport.com/methodology