# K954687: Access Rubella Igg

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories, Inc.
- Decided: Apr 9, 1996 after 181 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices 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) Abbott IMx Rubella IgG: named in the summary without a submission number

## Most influential descendants
- K250588: Access Rubella IgG (2025), 0 descendants of its own
- K031606: Access Immunoassay System Rubella Igg Assay (2003), 0 descendants of its own

## Indications for use
The ACCESS® Rubella IgG assay aids in the diagnosis of Rubella infection and the determination of immunity.

Source page: https://510kreport.com/device/K954687
Methodology: https://510kreport.com/methodology