# K981729: IS-Rubella Igg Test System

- Pathway: 510(k) (Traditional)
- Applicant: Diamedix Corp.
- Decided: Jan 28, 1999 after 258 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.
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. The FDA summary names its predicate without a number.
- (no number) Incstar Rubella IgG "fast" ELISA Kit: named in the summary without a submission number

## Indications for use
The Diamedix Is-Rubella IgG Test Kit is an Enzyme Immunoassay (EIA) for the qualitative and quantitative determination of IgG antibodies in human serum to aid in the assessment of the patient's immunological response to infection with rubella and in the determination of the immune status of individuals, including females of child-bearing age. The evaluation of acute and convalescent sera can aid in the diagnosis of recent or current infection with rubella. These reagents can be used either manually or in conjunction with the MAGO® Plus Automated EIA Processor.

Source page: https://510kreport.com/device/K981729
Methodology: https://510kreport.com/methodology