510(k) · Cleared
ClearedNuclisens Easyq Enterovirus System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
bioMerieux, Inc. · OAI Assay, Enterovirus Nucleic Acid
Cleared on Jun 23, 2008 after a 602-day review. The FDA summary names its predicate without a number.
- Decided
- Jun 23, 2008
- Review
- 602 days
- Class
- Class II
- Product code
- OAI
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 OAI? 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? (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 |
|---|---|---|---|
| * | — | Cell Culture for Enterovirus Detection [pre-amendment test method; no 510(k) applies] Named without a submission number |
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.
How does its category compare?
All OAI devicesOAI Assay, Enterovirus Nucleic Acid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · OAI
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · OAI
Too few OAI 510(k)s in any year since 2007 to give a median.
Recalls per year · OAI
No recall names OAI since 2007.
Adverse event reports per year · OAI
1in 2017
MAUDE reports naming product code OAI, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 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 NucliSens EasyQ® Enterovirus v1.1 Assay is an in vitro nucleic acid amplification assay to be used in conjunction with the NucliSens EasyQ® System for the qualitative detection of Enterovirus RNA in cerebral spinal fluid (CSF) specimens in patients with signs and symptoms of meningitis. This test, in conjunction with other laboratory results and clinical information, may be used as an aid in the presumptive laboratory diagnosis of enterovirus…
Read the full statement (159 words)
The NucliSens EasyQ® Enterovirus v1.1 Assay is an in vitro nucleic acid amplification assay to be used in conjunction with the NucliSens EasyQ® System for the qualitative detection of Enterovirus RNA in cerebral spinal fluid (CSF) specimens in patients with signs and symptoms of meningitis. This test, in conjunction with other laboratory results and clinical information, may be used as an aid in the presumptive laboratory diagnosis of enterovirus infection in pediatric patients with a clinical suspicion of aseptic meningitis or aseptic meningioencephalitis.
Negative results should be confirmed by cell culture.
Assay performance characteristics have not been established for adults, or for immunocompromised or immunosuppressed patients.
Caution: The results obtained with the NucliSens EasyQ Enterovirus v1.1 Assay should be used only as an adjunct to clinical observation and other information available to the physician. Positive results do not rule out other causes of meningitis, including bacteria, mycobacteria, other viruses (e.g. herpes family viruses, arboviruses, mumps virus, etc) and fungi.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063261 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063261: Nuclisens Easyq Enterovirus System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063261
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026