# K082150: Modification to Paxgene Blood Rna System

- Pathway: 510(k) (Special)
- Applicant: Preanalytix GmbH
- Decided: Feb 4, 2009 after 189 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
Longest line of descent: 1 generation back to DEN050003 (2005). 1 ancestor in all.
1 later device descends from it; 1 cites 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)
- DEN050003: Paxgene Blood Rna System, Preanalytix GmbH (2005). Our reading of the summary gave K042613, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN050003, Paxgene Blood Rna System (Preanalytix GmbH), granted Apr 18, 2005; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Most influential descendants
- K113420: Rnaretain (2012), 0 descendants of its own

## Indications for use
PAXgene Blood RNA Kit is for the purification of intracellular RNA from whole blood collected in the PAXgene Blood RNA Tube. When the kit is used in conjunction with the PAXgene Blood RNA Tube, the system provides purified intracellular RNA from whole blood for RT-PCR used in molecular diagnostic testing. Performance characteristics for the PAXgene Blood RNA System have only been established with FOS and IL1B gene transcripts. The user is responsible for establishing appropriate PAXgene Blood RNA System performance characteristics for other target transcripts.

Source page: https://510kreport.com/device/K082150
Methodology: https://510kreport.com/methodology