# K003178: Elecsys HCG and Beta Test System

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Dec 14, 2000 after 64 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K223690: iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) (2023), 0 descendants of its own
- K131037: Liaison XL HCG (2013), 0 descendants of its own

Source page: https://510kreport.com/device/K003178
Methodology: https://510kreport.com/methodology