510(k) · Cleared
ClearedWest Nile Virus Igm Capture Elisa
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 Jun 30, 2004 as substantially equivalent to K913618 (Hillcrest Biologicals, 1992) and 2 other predicates after a 90-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it.
- Decided
- Jun 30, 2004
- Review
- 90 days
- Class
- Class II
- Product code
- NOP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K993724 (2000). 3 ancestors in all, the oldest K913618 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK993724 HSV-2 Elisa Igg, Model EL0920GMrl Diagnostics · 2000
- 1 generation backK031952 West Nile Virus Igm Capture Elisa, Model EL0300MFocus Technologies, Inc. · 2003
- This deviceK040854 West Nile Virus Igm Capture ElisaFocus Technologies, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK153308 EUROIMMUN Anti-West Nile Virus ELISA (IgM)Euroimmun Us, Inc. · 2016
Most influential descendants
Showing 1 of 1 · See all- K153308EUROIMMUN Anti-West Nile Virus ELISA (IgM)Euroimmun Us, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K993724 | HSV-2 Elisa Igg, Model EL0920G | Mrl Diagnostics | 2000 | — |
| −1 | K031952 | West Nile Virus Igm Capture Elisa, Model EL0300M | Focus Technologies, Inc. | 2003 | — |
| 0 (this device) | K040854 | West Nile Virus Igm Capture Elisa | Focus Technologies, Inc. | 2004 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (5)
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 |
|---|---|---|---|
| * | K913618 | Arbovirus Igm Ifa TestSummary page 1…21 CFR §866.3940 Class II Predicate Device Focus Technologies Arbovirus IFA 1gM (K913618) Focus Technologies HSV-2 ELISA (K993724)… | 1992 |
| * | K993724 | HSV-2 Elisa Igg, Model EL0920GSummary page 1…redicate Device Focus Technologies Arbovirus IFA 1gM (K913618) Focus Technologies HSV-2 ELISA (K993724) Focus West Nile Virus IgM Capture ELISA (K031952)… | 2000 |
| * | K031952 | West Nile Virus Igm Capture Elisa, Model EL0300MSummary page 1…Focus Technologies HSV-2 ELISA (K993724) Focus West Nile Virus IgM Capture ELISA (K031952) CDC West Nile Virus IgM Capture ELISA… | 2003 |
| * | — | 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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153308 | EUROIMMUN Anti-West Nile Virus ELISA (IgM) | 2016 | 0 |
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 4 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K153308 (Euroimmun Us, Inc., 2016) has gone furthest, with 0 descendants of its own.
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 meningioencephalitis, as an aid in the presumptive laboratory diagnosis of West Nile virus infection. Positive results must be tested using the background subtraction method…
Read the full statement (130 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 meningioencephalitis, as an aid in the presumptive laboratory diagnosis of West Nile virus infection. Positive results must be tested using the background subtraction method (either on the initial test or on a repeat test). 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/K040854 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040854: West Nile Virus Igm Capture Elisa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040854
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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