# K983805: The Aptus (Automated) Application of the Rubella Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) FO

- Pathway: 510(k) (Traditional)
- Applicant: Zeus Scientific, Inc.
- Decided: May 26, 1999 after 210 days
- Product code: LFX (Enzyme Linked Immunoabsorbent Assay, Rubella)
- Device class: 2
- Regulation: 21 CFR 866.3510
- 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K072617: Elecsys Rubella Igg Immunoassay (2008), 2 descendants of its own
- K131605: Elecsys Precicontrol CMV Igg, Elecsys CMV Igg Immunoassay (2014), 1 descendant of its own
- K220911: Elecsys CMV IgG (2022), 0 descendants of its own

## Indications for use
The Rubella IgG ELISA test system is an enzyme linked immunosorbent assay (ELISA) intended for the manual or automated (Aptus) qualitative detection of IgG antibodies to Rubella virus in human serum. The test system is intended to be used to evaluate single sera for immune status or paired sera to demonstrate seroconversion, and is for in vitro diagnostic use.

Source page: https://510kreport.com/device/K983805
Methodology: https://510kreport.com/methodology