# LFZ: Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

- Device class: 2; regulation: 21 CFR 866.3175; FDA's rule: 510(k) required
- FDA decisions: 58
- 510(k) review time 2021–2025: median 203 days (middle half 200–206)
- Recalls: 7 (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)
- 1994: 1
- 1996: 7
- 1997: 3
- 1998: 3
- 1999: 3
- 2005: 1
- 2014: 2
- 2017: 2
- 2018: 1
- 2022: 2

## Most-cited predicates
- K920661: Vidas CMV Igg Assay (1993), cited by 3
- K040290: Diasorin Liaison CMV Igm/Igg (2005), cited by 3
- K915892: CMV Igg Elisa Test (1992), cited by 2
- K981163: Diamedix IS-CMV Igg Test System (1998), cited by 1
- K924096: CMV Elisa Test System (1993), cited by 1
- K181213: ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control (2018), cited by 1
- K955361: Incstar Cytomegalovirus Igg Elisa Assay (1996), cited by 1
- K131605: Elecsys Precicontrol CMV Igg, Elecsys CMV Igg Immunoassay (2014), cited by 1
- K142133: Elecys CMV Igm Immunoassay; Elecys Precicontrol CMV Igm (2014), cited by 1
- K896295: Captia (R) CMV-M (1990), cited by 1

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