# NXD: Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna

- Device class: 2; regulation: 21 CFR 866.3332; FDA's rule: 510(k) required
- FDA decisions: 3
- 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)
- 2006: 1
- 2008: 1
- 2010: 1

## Most-cited predicates
- K080570: CDC Human Influenza Virus Real-Time RT- PCR Detection and Characterization Panel (2008), cited by 8
- DEN060008: Influenza a/H5 (Asian Lineage) Virus Real-Time RT-PCR Primer and Probe Set (2006), cited by 2

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