# K203227: Elecsys HCG STAT

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Aug 18, 2021 after 289 days
- Product code: DHA (System, Test, Human Chorionic Gonadotropin)
- Device class: 2
- Regulation: 21 CFR 862.1155
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002148 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002148: Elecsys HCG Test System, Roche Diagnostics Corp. (2000) Summary page 5.

## Indications for use
For the in vitro quantitative determination of human chorionic gonadotropin (hCQ) in human serum and plasma. The Elecsys HCG STAT immunoassay is intended for use in the early detection of pregnancy. The electrochemiluminescence immunoassay “ECLIA” is intended for use on the cobas e 601 immunoassay analyzer.

Source page: https://510kreport.com/device/K203227
Methodology: https://510kreport.com/methodology