510(k) · Cleared
ClearedEUROIMMUN Anti-West Nile Virus ELISA (IgM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Euroimmun Us, Inc. · NOP Elisa, Antibody, West Nile Virus
Cleared on Aug 12, 2016 as substantially equivalent to K040854 (Focus Technologies, Inc., 2004) after a 269-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Aug 12, 2016
- Review
- 269 days
- Class
- Class II
- Product code
- NOP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K993724 (2000). 4 ancestors in all, the oldest K913618 (1992). No later device cites it as a predicate yet.
- Root · 3 generations backK993724 HSV-2 Elisa Igg, Model EL0920GMrl Diagnostics · 2000
- 2 generations backK031952 West Nile Virus Igm Capture Elisa, Model EL0300MFocus Technologies, Inc. · 2003
- 1 generation backK040854 West Nile Virus Igm Capture ElisaFocus Technologies, Inc. · 2004
- This deviceK153308 EUROIMMUN Anti-West Nile Virus ELISA (IgM)Euroimmun Us, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K993724 | HSV-2 Elisa Igg, Model EL0920G | Mrl Diagnostics | 2000 | — |
| −2 | K031952 | West Nile Virus Igm Capture Elisa, Model EL0300M | Focus Technologies, Inc. | 2003 | — |
| −1 | K040854 | West Nile Virus Igm Capture Elisa | Focus Technologies, Inc. | 2004 | — |
| 0 (this device) | K153308 | EUROIMMUN Anti-West Nile Virus ELISA (IgM) | Euroimmun Us, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 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 NOP? 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 |
|---|---|---|---|
| * | K040854 | West Nile Virus Igm Capture ElisaSummary page 5…nti-West Nile Virus Focus Diagnostics West Nile Virus ELISA (IgM) (K153308) IgM DxSelect™ ELISA (K040854) Intended use Detection of IgM class antibodies against West Same Nile virus Assay form… | 2004 |
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 16 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All NOP devicesNOP Elisa, Antibody, West Nile Virus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · NOP
2in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · NOP
Too few NOP 510(k)s in any year since 2007 to give a median.
Recalls per year · NOP
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NOP
1in 2019
MAUDE reports naming product code NOP, 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 | 1 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 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 EUROIMMUN Anti-West Nile Virus ELISA (IgM) is intended for the qualitative detection of IgM antibodies to West Nile virus in human serum and plasma (K+-EDTA, Li+-heparin). This test is intended as an aid in the presumptive laboratory diagnosis of West Nile virus infection in patients with clinical symptoms consistent with meningitis/encephalitis, in conjunction with other laboratory and clinical findings. Positive results must be confirmed by the…
Read the full statement (161 words)
The EUROIMMUN Anti-West Nile Virus ELISA (IgM) is intended for the qualitative detection of IgM antibodies to West Nile virus in human serum and plasma (K+-EDTA, Li+-heparin). This test is intended as an aid in the presumptive laboratory diagnosis of West Nile virus infection in patients with clinical symptoms consistent with meningitis/encephalitis, in conjunction with other laboratory and clinical findings. Positive results must be confirmed by the plaque reduction neutralization test (PRNT) or by using the current CDC guidelines for diagnosis of this disease.
The assay characteristics have not been established for testing cord blood, neonates, prenatal screening, and general population screening of patients without symptoms of meningoencephalitis. This assay is not FDA cleared or approved for testing blood or plasma donors.
Warning: Cross-reactivity with IgM to Dengue virus, Malaria/anti-Plasmodium falciparum and Parvovirus B19 has been observed with the EUROIMMUN Anti-West Nile Virus ELISA (IgM). Reactive results must be reported with a caution statement regarding possible IgM cross-reactivity with other flaviviruses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153308 · printed Nov 3, 2026
Cite this page
510(k) Report. “K153308: EUROIMMUN Anti-West Nile Virus ELISA (IgM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K153308
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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