510(k) · Cleared
ClearedRnaretain
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Asuragen, Inc. · OZF Tissue Rna Preservative For Collection, Storage, And Transportation
Cleared on Mar 16, 2012 as substantially equivalent to DEN050003 (Preanalytix GmbH, 2005) and 1 other predicate after a 119-day review. Its family tree reaches back 2 generations to 2005.
- Decided
- Mar 16, 2012
- Review
- 119 days
- Class
- Class II
- Product code
- OZF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to DEN050003 (2005). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 OZF? 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
What was it cleared against? (2)
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 | Decided |
|---|---|---|---|
| * | 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. | 2005 |
| * | K082150 | Modification to Paxgene Blood Rna SystemSummary page 4…est Article Predicate Name RNARetaino PAXgene" Blood RNA System 510(k) k113420 k082150; k042613 number 510(k) holder Asuragen, Inc. PreAnalytiX GMBH Austin, TX… | 2009 |
| † | K070675 | Mammaprint | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 3.8 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate DEN050003.
How does its category compare?
All OZF devicesOZF Tissue Rna Preservative For Collection, Storage, And Transportation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · OZF
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · OZF
Too few OZF 510(k)s in any year since 2007 to give a median.
Recalls per year · OZF
No recall names OZF since 2007.
Adverse event reports per year · OZF
No MAUDE report names OZF since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113420 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113420: Rnaretain.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113420
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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