# K043095: Roche Diagnostics Elecsys Afp Calset II

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Nov 23, 2004 after 14 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- 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 1.

## Indications for use
The Elecsys AFP CalSet II is used for calibrating the quantitative AFP assay on the Elecsys immunoassay systems.

Source page: https://510kreport.com/device/K043095
Methodology: https://510kreport.com/methodology