510(k) · Cleared
Recalled · Class II · 2020Rotor-Gene Q MDX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
QIAGEN GmbH · OOI Real Time Nucleic Acid Amplification System
Cleared on Feb 6, 2012 as substantially equivalent to K092705 (Abbott Molecular, Inc., 2010) after an 88-day review. Its family tree reaches back 4 generations to 1993. It has been recalled once.
- Decided
- Feb 6, 2012
- Review
- 88 days
- Class
- Class II
- Product code
- OOI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K922906 (1993). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK922906 Amplicor Chlamydia Trachomatis TestRoche Molecular Systems, Inc. · 1993
- 3 generations backK964506 Roche Cobas Amplicor AnalyzerRoche Molecular Systems, Inc. · 1997 · Recalled
- 2 generations backK012966 Roche Cobas Taqman AnalyzerRoche Molecular Systems, Inc. · 2002 · Recalled
- 1 generation backK092705 Abbott M2000SP and Abbott M2000RT, Models 9K14-01 (G-Series)…Abbott Molecular, Inc. · 2010 · Recalled
- This deviceK113319 Rotor-Gene Q MDXQIAGEN GmbH · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K922906 | Amplicor Chlamydia Trachomatis Test | Roche Molecular Systems, Inc. | 1993 | — |
| −3 | K964506 | Roche Cobas Amplicor Analyzer | Roche Molecular Systems, Inc. | 1997 | 1 |
| −2 | K012966 | Roche Cobas Taqman Analyzer | Roche Molecular Systems, Inc. | 2002 | 3 |
| −1 | K092705 | Abbott M2000SP and Abbott M2000RT, Models 9K14-01 (G-Series), 9K14-02… | Abbott Molecular, Inc. | 2010 | 7 |
| 0 (this device) | K113319 | Rotor-Gene Q MDX | QIAGEN GmbH | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
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 OOI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OOI device
- #1 K243922 Revogenescore 9.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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 | Decided |
|---|---|---|---|
| * | K092705 | Abbott M2000SP and Abbott M2000RT, Models 9K14-01 (G-Series), 9K14-02 (E-Series), 9K1501Summary page 1…Device Manufacturer Product Name 510(k) No. Abbott Molecular Inc. Abbott' m2000" System, K092705 specifically m2000rt 4. Device Description The Rotor-Gene® Q MDx is a real-… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 28, 2020 | Class II | Z-1476-2020 | Software change control | When using the Rotor-Gene Q with Software version 2.3.4 completing a LIMs export, the .csv file reports the calculated concentration result value as a logarithmic value, and could lead to a false negative result, which could lead to… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- 4 of the 6 ancestors have a recall of any class.
- 1 other device also cites its predicate K092705.
How does its category compare?
All OOI devicesOOI Real Time Nucleic Acid Amplification System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · OOI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OOI
249in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OOI
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OOI
524in 2025
MAUDE reports naming product code OOI, not matched to any one device; reports are not rates.
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 | 3 | 249 | 1 | 0 |
| 2011 | 0 | — | 2 | 5 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 1 | — | 1 | 1 |
| 2014 | 1 | — | 0 | 5 |
| 2015 | 2 | — | 0 | 1 |
| 2016 | 2 | — | 0 | 3 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 134 |
| 2021 | 0 | — | 4 | 324 |
| 2022 | 1 | — | 4 | 874 |
| 2023 | 1 | — | 1 | 220 |
| 2024 | 0 | — | 1 | 327 |
| 2025 | 1 | — | 0 | 524 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Rotor-Gene Q MDx instrument with Rotor-Gene Q software version 2.1.0 or higher is a real-time nucleic acid amplification and detection system which measures nucleic acid signals from amplified DNA using fluorescent detection.
The Rotor-Gene Q MDx instrument is intended for in vitro diagnostic use with FDA cleared or approved nucleic acid tests in clinical laboratories.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113319 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113319: Rotor-Gene Q MDX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113319
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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