# PAB: Cytomegalovirus (Cmv) Dna Quantitative Assay

- Device class: 2; regulation: 21 CFR 866.3180; FDA's rule: 510(k) required
- FDA decisions: 9
- 510(k) review time 2021–2025: median 88 days (middle half 58–162)
- 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)
- 2016: 7
- 2017: 13
- 2018: 24
- 2019: 21
- 2020: 8
- 2021: 4
- 2022: 9
- 2023: 14
- 2024: 16
- 2025: 3

## Most-cited predicates
- P210022: Alinity m CMV (2022), cited by 1
- P210029: Aptima CMV Quant Assay (2022), cited by 1
- P160041: Cobas CMV (2017), cited by 1

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