# DEN050003: Paxgene Blood Rna System

- Pathway: De Novo (Post-NSE)
- Applicant: Preanalytix GmbH
- Decided: Apr 18, 2005 after 49 days
- Product code: NTW (System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test)
- Device class: 2
- Regulation: 21 CFR 866.4070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K082150: Modification to Paxgene Blood Rna System (2009), 1 descendant of its own
- K113420: Rnaretain (2012), 0 descendants of its own

Source page: https://510kreport.com/device/DEN050003
Methodology: https://510kreport.com/methodology