# K220176: Elecsys AFP

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Sep 15, 2022 after 237 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
Longest line of descent: 2 generations back to K973351 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981282: Elecsys Afp, Roche Diagnostics GmbH (1998) Summary page 4.

## Indications for use
Immunoassay for the in vitro quantitative determination of al-fetoprotein in human serum and plasma to aid in the management of patients with non-seminomatous germ cell tumors. The electrochemiluminescence immunoassay “ECLIA” is intended for use on the cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K220176
Methodology: https://510kreport.com/methodology