# K973351: Elecsys Afp

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Nov 21, 1997 after 77 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.
3 later devices descend from it; 1 cites 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)
- P860044: Enzymun-Test{R} Afp, Boehringer Mannheim Corp.. FDA lists this PMA only through its supplements; the earliest we hold is P860044/S001 (Aug 3, 1990). Summary page 1.

## Most influential descendants
- K981282: Elecsys Afp (1998), 2 descendants of its own
- 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 α-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 immunoassay analyzers.

Source page: https://510kreport.com/device/K973351
Methodology: https://510kreport.com/methodology