# MYF: Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2

- Device class: 2; regulation: 21 CFR 866.3305; FDA's rule: 510(k) required
- FDA decisions: 10
- 510(k) review time 2021–2025: median 140 days (middle half 113–168)
- Recalls: 1 (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)
- 2000: 1
- 2004: 1
- 2007: 1
- 2008: 1
- 2011: 1
- 2016: 1
- 2018: 1
- 2019: 1
- 2022: 1
- 2025: 1

## Most-cited predicates
- K993724: HSV-2 Elisa Igg, Model EL0920G (2000), cited by 3
- K152353: SeraQuest HSV Type 2 Specific IgG (2016), cited by 1

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