# LFY: Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster

- Device class: 2; regulation: 21 CFR 866.3900; FDA's rule: 510(k) required
- FDA decisions: 17
- 510(k) review time 2021–2025: median 182 days (middle half 182–182)
- Recalls: 3 (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)
- 1992: 2
- 1995: 1
- 1996: 2
- 1997: 1
- 1998: 1
- 1999: 1
- 2005: 1
- 2007: 2
- 2015: 1
- 2023: 1

## Most-cited predicates
- K981867: IS-Vzu Igg Test System (1998), cited by 1
- K061820: Diasorin Liaison VZV Igg (2007), cited by 1
- K150375: LIAISON VZV IgG, LIAISON Control VZV IgG (2015), cited by 1
- K923122: Vitek Immunodiagnostic Assay System (1992), cited by 1

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