# K984180: The Aptus (Automated) Application of the Rubella Igm Elisa Test System

- Pathway: 510(k) (Traditional)
- Applicant: Zeus Scientific, Inc.
- Decided: Jul 20, 1999 after 239 days
- Product code: LFX (Enzyme Linked Immunoabsorbent Assay, Rubella)
- Device class: 2
- Regulation: 21 CFR 866.3510
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 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
- K092322: Elecsys Rubella Igm Immunoassay (2010), 2 descendants of its own
- K072617: Elecsys Rubella Igg Immunoassay (2008), 2 descendants of its own
- K142133: Elecys CMV Igm Immunoassay; Elecys Precicontrol CMV Igm (2014), 1 descendant 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

## Recalls of this device
- Feb 24, 2000 · Not classified · Z-1065-03: The high positive control/low positive standard ratio recovering too low.

## Indications for use
The Rubella IgM ELISA test system is and enzyme-linked immunosorbent assay (ELISA) designed for the manual or automated (Aptus), qualitative determination of IgM-class antibody to rubelia virus in human serum. The test is intended to be used to evaluate serologic evidence of primary or active infection with Rubella and is for in vitro diagnostic use.

Source page: https://510kreport.com/device/K984180
Methodology: https://510kreport.com/methodology