# OPL: Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus

- Device class: 2; regulation: 21 CFR 866.3510; FDA's rule: 510(k) required
- FDA decisions: 3
- 510(k) review time 2021–2025: median 759 days (middle half 759–759)
- 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)
- 2010: 1
- 2011: 1
- 2023: 1

## Most-cited predicates
- K091616: Bioplex 2200 MMRV Igg (2010), cited by 2

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