# QLX: Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna

- Device class: 2; regulation: 21 CFR 866.3183; FDA's rule: 510(k) required
- FDA decisions: 4
- 510(k) review time 2021–2025: median 258 days (middle half 173–288)
- 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)
- 2020: 1
- 2021: 1
- 2022: 1
- 2025: 1

## Most-cited predicates
- DEN200015: cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit (2020), cited by 2
- K212778: Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075) (2022), cited by 1
- K203220: cobas BKV (2021), cited by 1

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