# K113420: Rnaretain

- Pathway: 510(k) (Traditional)
- Applicant: Asuragen, Inc.
- Decided: Mar 16, 2012 after 119 days
- Product code: OZF (Tissue Rna Preservative For Collection, Storage, And Transportation)
- 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: 2 generations back to DEN050003 (2005). 2 ancestors in all.
No later device cites it as a predicate yet.
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.
- K082150: Modification to Paxgene Blood Rna System, Preanalytix GmbH (2009) Summary page 4.

## Indications for use
The RNARetain® device is a single-use, prefilled container intended for the collection, storage, and transportation of fresh breast tissue specimens for subsequent RNA isolation and further molecular diagnostic testing. For Professional Use Only.

Source page: https://510kreport.com/device/K113420
Methodology: https://510kreport.com/methodology