# MXJ: Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1

- Device class: 2; regulation: 21 CFR 866.3305; FDA's rule: 510(k) required
- FDA decisions: 20
- 510(k) review time 2021–2025: median 417 days (middle half 306–528)
- Recalls: 0 (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)
- 2008: 2
- 2009: 1
- 2011: 1
- 2012: 2
- 2014: 1
- 2015: 1
- 2016: 1
- 2018: 1
- 2022: 1
- 2023: 1

## Most-cited predicates
- K021486: Herpeselect 2 Elisa Igg, Model ELO920G (2002), cited by 1
- K120625: Elecsys HSV-1 Igg Immunoassay Elecsys Precicontrol HSV (2012), cited by 1
- K021429: Herpeselect 1 Elisa Igg, Model EL0910G (2002), cited by 1
- K090409: Bioplex 2200 HSV-1 and HSV-2 Igg on the Bioplex 2200 Multi-Analyte Detection System (2009), cited by 1

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