# K982078: Immulite Rubella Quantitative Igg, Catalog # LKRBQ1 (100 Tests), LKRBQ5 (500 Tests)

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Dec 11, 1998 after 179 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 Quantitative is a solid-phase chemiluminescent enzyme immunoassay for use on the IMMULITE Automated Analyzer and designed for the quantitative measurement 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, particularly for women of childbearing age. The performance characteristics of the assay have not been established for use with neonate and cord blood specimens

Source page: https://510kreport.com/device/K982078
Methodology: https://510kreport.com/methodology