# K080094: Olympus Total BHCG Test Systen

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Life Science Research Europa GmbH (Europa)
- Decided: Sep 3, 2008 after 233 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Olympus βhCG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total beta human chorionic gonadotropin (intact βhCG and free β) levels in human serum using the Olympus AU3000i Immunoassay System. Total βhCG is used for the early detection of pregnancy. For in vitro diagnostic use only. The Olympus βhCG Calibrator is for calibrating the quantitative Olympus βhCG assay on the Olympus AU3000i Immunoassay System. The Olympus βhCG Control is used for quality control of the Olympus βhCG assay on the Olympus AU3000i Immunoassay System.

Source page: https://510kreport.com/device/K080094
Methodology: https://510kreport.com/methodology