510(k) · Cleared
ClearedWest Nile Virus Igm Capture Elisa, Model EL0300M
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Focus Technologies, Inc. · NOP Elisa, Antibody, West Nile Virus
Cleared on Oct 22, 2003 as substantially equivalent to K993724 (Mrl Diagnostics, 2000) after a 119-day review. Its family tree reaches back 1 generation to 2000. 3 later devices descend from it.
- Decided
- Oct 22, 2003
- Review
- 119 days
- Class
- Class II
- Product code
- NOP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K993724 (2000). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK993724 HSV-2 Elisa Igg, Model EL0920GMrl Diagnostics · 2000
- This deviceK031952 West Nile Virus Igm Capture Elisa, Model EL0300MFocus Technologies, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK040854 West Nile Virus Igm Capture ElisaFocus Technologies, Inc. · 2004
- Descendant · 2 generations on · 0 of its ownK153308 EUROIMMUN Anti-West Nile Virus ELISA (IgM)Euroimmun Us, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK052519 Spectral West Nile Virus Igm Status TestSpectral Diagnostics, Inc. · 2006
Most influential descendants
Showing 3 of 3 · See all- K040854West Nile Virus Igm Capture ElisaFocus Technologies, Inc. · 2004 · cites it directly1descendant
- K153308EUROIMMUN Anti-West Nile Virus ELISA (IgM)Euroimmun Us, Inc. · 2016 · 2 generations on0descendants
- K052519Spectral West Nile Virus Igm Status TestSpectral Diagnostics, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K993724 | HSV-2 Elisa Igg, Model EL0920G | Mrl Diagnostics | 2000 | — |
| 0 (this device) | 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 | — |
| +2 | K153308 | EUROIMMUN Anti-West Nile Virus ELISA (IgM) | Euroimmun Us, Inc. | 2016 | — |
| +1 | K052519 | Spectral West Nile Virus Igm Status Test | Spectral Diagnostics, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2016 | 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? (4)
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 |
|---|---|---|---|
| * | K993724 | HSV-2 Elisa Igg, Model EL0920GSummary page 1…dicate Device Focus Technologies Arbovirus IFA IgM (1 9 36 Focus Technologies HSV-2 ELISA (K993724) CDC West Nile Virus IgM Capture ELISA… | 2000 |
| * | — | Focus Technologies Arbovirus IFA IgM Named without a submission number | |
| * | — | CDC West Nile Virus IgM Capture ELISA Named without a submission number | |
| * | — | West Nile Virus Plaque-Reduction Neutralization Test Named without a submission number |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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.
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 Focus Technologies West Nile Virus IgM Capture ELISA is intended for qualitatively detecting IgM antibodies to West Nile virus in human serum. In conjunction with the Focus Technologies West Nile Virus ELISA IgG, the test is indicated for testing persons having symptoms of meningoencephalitis, as an aid in the presumptive laboratory diagnosis of West Nile virus infection. Positive results must be confirmed by neutralization test, or by using the…
Read the full statement (110 words)
The Focus Technologies West Nile Virus IgM Capture ELISA is intended for qualitatively detecting IgM antibodies to West Nile virus in human serum. In conjunction with the Focus Technologies West Nile Virus ELISA IgG, the test is indicated for testing persons having symptoms of meningoencephalitis, as an aid in the presumptive laboratory diagnosis of West Nile virus infection. Positive results must be confirmed by neutralization test, or by using the current CDC guidelines for diagnosing West Nile encephalitis. This test is not intended for self-testing, and this test is not FDA cleared nor approved for testing blood or plasma donors. Assay performance characteristics have not been established for automated instruments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031952 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031952: West Nile Virus Igm Capture Elisa, Model EL0300M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031952
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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