# K963613: Immulite Rubella Igg

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Apr 2, 1997 after 204 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
Longest line of descent: 1 generation back to K885297 (1989). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K885297: Imx Rubella Igg, Microparticle Enzyme Immunoassay, Abbott Laboratories (1989) Summary page 1.

## Indications for use
IMMULITE Rubella IgG is designed for the qualitative detection of IgG antibodies to Rubella virus in human serum. It is intended strictly for in vitro diagnostic use as an aid in the determination of immune status to rubella. This assay is particularly useful as an indicator of immune status for women of childbearing age.

Source page: https://510kreport.com/device/K963613
Methodology: https://510kreport.com/methodology