510(k) · Cleared
Recalled · 2011Nuclisens Easyq Enterovirus V1.1., Nuclisens Easyq Director 2.6, Nuclisens Easyq Analyzer, Nuclisens Minimag
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
bioMerieux, Inc. · OOI Real Time Nucleic Acid Amplification System
Cleared on Jul 6, 2010 as substantially equivalent to K082562 (Applied Biosystems, Inc., 2008) after a 249-day review. Its family tree reaches back 1 generation to 2008. 1 later device descends from it. It has been recalled once.
- Decided
- Jul 6, 2010
- Review
- 249 days
- Class
- Class II
- Product code
- OOI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K082562 (2008). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK082562 Applied Biosystems 7500 Fast DXApplied Biosystems, Inc. · 2008
- This deviceK093383 Nuclisens Easyq Enterovirus V1.1., Nuclisens Easyq Director 2.6…bioMerieux, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK102740 Nuclisens Easyq Mrsa; Nuclisens Easyq Analyzer; Nuclisens Easyq…bioMerieux, Inc. · 2011
Most influential descendants
Showing 1 of 1 · See all- K102740Nuclisens Easyq Mrsa; Nuclisens Easyq Analyzer; Nuclisens Easyq Incubator (110 Volt)…bioMerieux, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K082562 | Applied Biosystems 7500 Fast DX | Applied Biosystems, Inc. | 2008 | — |
| 0 (this device) | K093383 | Nuclisens Easyq Enterovirus V1.1., Nuclisens Easyq Director 2.6, Nuclisens… | bioMerieux, Inc. | 2010 | — |
| +1 | K102740 | Nuclisens Easyq Mrsa; Nuclisens Easyq Analyzer; Nuclisens Easyq Incubator (110… | bioMerieux, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 |
|---|---|---|---|
| * | K082562 | Applied Biosystems 7500 Fast DXSummary page 1…evice, which isthe subject of this submission, is claimed equivalent to the Applied Biosystems; 7500 Fast Dx Real-Time PCR Instrument with the SIDS Software version 1.4 (K082562). Intended Use of the Device In vitro diagnostic medical device. The NucliSENS EasyQ Analyzer and the accompanying NucliSENS Eas… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102740 | Nuclisens Easyq Mrsa; Nuclisens Easyq Analyzer; Nuclisens Easyq Incubator (110 Volt)… | 2011 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 10, 2011 | Not classified | Z-2740-2011 | Device Design | The NucliSENS EasyQ Enterovirus Reagents are unable to detect Enterovirus serotype 68, in respiratory samples. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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. 2010, 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 NucliSENS EasyQ Analyzer and the accompanying NucliSENS EasyQ Director software are intended for in vitro diagnostic use in conjunction with FDA-cleared or approved NucliSENS assay protocols. The user shall be a properly trained laboratory technician familiar with performing nucleic acid assays. The analyzer is intended to measure fluorescent readings from molecular beacon probes binding to amplified RNA or DNA in samples containing NucliSENS EasyQ…
Read the full statement (130 words)
The NucliSENS EasyQ Analyzer and the accompanying NucliSENS EasyQ Director software are intended for in vitro diagnostic use in conjunction with FDA-cleared or approved NucliSENS assay protocols. The user shall be a properly trained laboratory technician familiar with performing nucleic acid assays. The analyzer is intended to measure fluorescent readings from molecular beacon probes binding to amplified RNA or DNA in samples containing NucliSENS EasyQ assay reagents while controlling the temperature of the samples. The NucliSENS EasyQ Director software is intended to control instrument operations and organize the assays to be performed. In addition, the software is intended to automatically calculate results for each test request based on raw measurement data, the data reduction algorithm specified for the assay, and the batch parameters of the reagents used for the test.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093383 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093383: Nuclisens Easyq Enterovirus V1.1., Nuclisens Easyq Director 2.6, Nuclisens Easyq Analyzer, Nuclisens Minimag.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093383
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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