# K081709: Olympus Afp - Alpha-Fetoprotein

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Life Science Research Europa GmbH (Europa)
- Decided: Mar 16, 2009 after 272 days
- Product code: LOJ (Kit, Test,Alpha-Fetoprotein For Testicular Cancer)
- Device class: 2
- Regulation: 21 CFR 866.6010
- 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 AFP assay is a paramagnetic particle (Dynabeadse), chemiluminescent immunoassay for the quantitative determination of alpha-fetoprotein levels in human serum and lithium heparin plasma using the Olympus AU3000i Immunoassay System. The Olympus AFP assay is intended for use as an aid in the management of patients with non-seminomatous germ cell tumors. For in vitro diagnostic use only. The Olympus AFP Calibrator is for calibrating the quantitative Olympus AFP assay on the Olympus AU3000i Immunoassay System. The Olympus AFP Control is used for quality control of the Olympus AFP assay on the Olympus AU3000i Immunoassay System.

Source page: https://510kreport.com/device/K081709
Methodology: https://510kreport.com/methodology