# DEN060008: Influenza a/H5 (Asian Lineage) Virus Real-Time RT-PCR Primer and Probe Set

- Pathway: De Novo (Post-NSE)
- Applicant: Centers for Disease Control and Prevention
- Decided: Feb 3, 2006 after 7 days
- Product code: NXD (Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna)
- Device class: 2
- Regulation: 21 CFR 866.3332
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
64 later devices descend from it; 2 cite it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K080570: CDC Human Influenza Virus Real-Time RT- PCR Detection and Characterization Panel (2008), 59 descendants of its own
- K100148: Simplexa Influenza a H1N1 (2009) Model MOL2500 (2010), 34 descendants of its own
- K103766: Xpert Flu, Genexpert DX Systems, Genexpert Infinity System, Genexpert System Software Verisions 2.1 and 4.0 (2011), 27 descendants of its own
- K101564: CDC Influenza 2009 a (H1N1)PDM Real-Time RT-PCR Panel (2010), 19 descendants of its own
- K111387: Liat (TM) Influenza a / B Assay, Liat (TM) Analyzer (2011), 18 descendants of its own

Source page: https://510kreport.com/device/DEN060008
Methodology: https://510kreport.com/methodology