510(k) · Cleared

Cleared

Modification to Paxgene Blood Rna System

K082150510(k) SpecialCleared Feb 4, 2009189-day reviewClass II21 CFR 866.4070

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Preanalytix GmbH · NTW System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test

Cleared on Feb 4, 2009 as substantially equivalent to DEN050003 (Preanalytix GmbH, 2005) after a 189-day review. Its family tree reaches back 1 generation to 2005. 1 later device descends from it.

Decided: Feb 4, 2009
Review: 189 days
Class: Class II
Product code: NTW
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to DEN050003 (2005). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backDEN050003 Paxgene Blood Rna SystemPreanalytix GmbH · 2005
This deviceK082150 Modification to Paxgene Blood Rna SystemPreanalytix GmbH · 2009
Descendant · cites it directly · 0 of its ownK113420 RnaretainAsuragen, Inc. · 2012

Most influential descendants

Showing 1 of 1 · See all

K113420RnaretainAsuragen, Inc. · 2012 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	DEN050003	Paxgene Blood Rna System	Preanalytix GmbH	2005	—
0 (this device)	K082150	Modification to Paxgene Blood Rna System	Preanalytix GmbH	2009	—
+1	K113420	Rnaretain	Asuragen, Inc.	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0

FIG. 1 — Lineage of K082150, 2005–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in NTW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	DEN050003	Paxgene Blood Rna System 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.	Preanalytix GmbH	2005	—

Also cleared against DEN050003: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K113420	Rnaretain	Asuragen, Inc.	2012	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K113420 (Asuragen, Inc., 2012) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate DEN050003.

How does its category compare?

All NTW devices

NTW System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · NTW

1in 2009

2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NTW

Too few NTW 510(k)s in any year since 2007 to give a median.

Recalls per year · NTW

No recall names NTW since 2007.

Adverse event reports per year · NTW

11in 2025

2007high 44 (2018) · low 0 (2007)2025

MAUDE reports naming product code NTW, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	1	—	0
2010	0	—	1
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	2
2018	0	—	44
2019	0	—	21
2020	0	—	7
2021	0	—	12
2022	0	—	11
2023	0	—	20
2024	0	—	12
2025	0	—	11
2026	0	—	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082150 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082150: Modification to Paxgene Blood Rna System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082150

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026