# K981282: Elecsys Afp

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics GmbH
- Decided: May 1, 1998 after 23 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: 1 generation back to K973351 (1997). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973351: Elecsys Afp, Boehringer Mannheim Corp. (1997) Summary page 2.

## Most influential descendants
- K220176: Elecsys AFP (2022), 0 descendants of its own
- K043095: Roche Diagnostics Elecsys Afp Calset II (2004), 0 descendants of its own

## Indications for use
Immunoassay for the in vitro quantitative determination of alpha-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 Boehringer Mannheim Elecsys 1010 and 2010 immunoassay analyzers.

Source page: https://510kreport.com/device/K981282
Methodology: https://510kreport.com/methodology