# K951359: Rubella Igg Assay for the Technicon Immuno 1 System in-Vitro Diagnostic Device

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Apr 15, 1996 after 385 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) Sanofi Platelia Rubella IgG kit: named in the summary without a submission number
- (no number) Abbott IMx Rubella IgG assay: named in the summary without a submission number

## Indications for use
This in vitro diagnostic method is intended to quantitatively measure Rubella IgG in human serum on the Technicon Immuno 1® System. Measurements of Rubella IgG are designed to aid in the determination of immune status by detecting IgG class antibodies to rubella virus in human sera. The method is not intended for use on any other system.

Source page: https://510kreport.com/device/K951359
Methodology: https://510kreport.com/methodology