# K983418: The Aptus (Automated)Application of the Rheumatoid Factor Igm Elisa Test System. an Enzyme Linked Immunosorbent Assay (EL

- Pathway: 510(k) (Traditional)
- Applicant: Zeus Scientific, Inc.
- Decided: Nov 18, 1998 after 50 days
- Product code: DHR (System, Test, Rheumatoid Factor)
- Device class: 2
- Regulation: 21 CFR 866.5775
- 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 Zeus Scientific, Inc. Rheumatoid Factor IgM ELISA test system is intended for the qualitative and semi-quantitative detection of RF IgM class antibody in human serum. The test system is intended for the manual or automated analysis of human serum for the presence of IgM RF. The test system is intended to be used as aid in the diagnosis of rheumatoid arthritis. The test is for in vitro diagnostic use.

Source page: https://510kreport.com/device/K983418
Methodology: https://510kreport.com/methodology