# LFX: Enzyme Linked Immunoabsorbent Assay, Rubella

- Device class: 2; regulation: 21 CFR 866.3510; FDA's rule: 510(k) required
- FDA decisions: 94
- 510(k) review time 2021–2025: median 263 days (middle half 263–263)
- Recalls: 15 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2001: 2
- 2002: 1
- 2003: 1
- 2006: 1
- 2007: 1
- 2008: 3
- 2010: 2
- 2011: 1
- 2012: 1
- 2025: 2

## Most-cited predicates
- K954687: Access Rubella Igg (1996), cited by 2
- K885297: Imx Rubella Igg, Microparticle Enzyme Immunoassay (1989), cited by 2
- K080766: Vidas Rub Igg (2008), cited by 2
- K954045: Axsym Rubella Igg Antibody Assay (1996), cited by 2
- K010668: Bayer Diagnostics Advia Centaur Rubella Igm Assay (2001), cited by 2
- K984180: The Aptus (Automated) Application of the Rubella Igm Elisa Test System (1999), cited by 2
- K860145: Rubella Elisa Test System Catalog Number: 4540 (1986), cited by 2
- K983805: The Aptus (Automated) Application of the Rubella Igg Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) FO (1999), cited by 1
- K072617: Elecsys Rubella Igg Immunoassay (2008), cited by 1
- K092587: Bioplex 2200 Rubella & CMV Igm Kit on the Bioplex 2200 Multi Analyte Detection System (2010), cited by 1

Source page: https://510kreport.com/product-code/LFX
Data by year (CSV): https://510kreport.com/product-code/LFX.csv