# DEN070013: ID-Tag Respiratory Viral Panel

- Pathway: De Novo (Post-NSE)
- Applicant: Luminex Molecular Diagnostics, Inc.
- Decided: Jan 3, 2008 after 30 days
- Product code: OCC (Respiratory Virus Panel Nucleic Acid Assay System)
- Device class: 2
- Regulation: 21 CFR 866.3980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
106 later devices descend from it; 12 cite it directly.
0 of 107 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
- K081483: Xtag Respiratory Viral Panel (2008), 91 descendants of its own
- K091667: Xtag Respiratory Viral Panel, Models I019A0110, I019C011, I019D0112, I019E0113, S019-0116 (2009), 89 descendants of its own
- K081030: Modification to Proflu+ Assay (2008), 45 descendants of its own
- K092500: Modification to Proflu+ Assay (2009), 41 descendants of its own
- K100148: Simplexa Influenza a H1N1 (2009) Model MOL2500 (2010), 34 descendants of its own

Source page: https://510kreport.com/device/DEN070013
Methodology: https://510kreport.com/methodology