510(k) · Cleared
Recalled · 2008West Nile Virus Igm Capture Elisa, Model E-WNV02M
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Panbio Limited · NOP Elisa, Antibody, West Nile Virus
Cleared on Aug 10, 2004 as substantially equivalent to DEN030004 (Panbio Limited, 2003) after a 92-day review. Its family tree reaches back 1 generation to 2003. It has been recalled once.
- Decided
- Aug 10, 2004
- Review
- 92 days
- Class
- Class II
- Product code
- NOP
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN030004 (2003). No later device cites it as a predicate yet.
- Root · 1 generation backDEN030004 West Nile Virus Igm Capture ElisaPanbio Limited · 2003
- This deviceK041231 West Nile Virus Igm Capture Elisa, Model E-WNV02MPanbio Limited · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN030004 | West Nile Virus Igm Capture Elisa | Panbio Limited | 2003 | — |
| 0 (this device) | K041231 | West Nile Virus Igm Capture Elisa, Model E-WNV02M | Panbio Limited | 2004 | — |
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 |
|---|---|---|---|
| * | DEN030004 | West Nile Virus Igm Capture Elisa Our reading of the summary gave K031703, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN030004, West Nile Virus Igm Capture Elisa (Panbio Limited), granted Jul 8, 2003; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 8, 2008 | Not classified | Z-1014-2012 | Nonconforming Material/Component | It has come to our attention that users of these product lots may experience an elevation in the rate of false positivity when compared with previous product lots. Internal quality assurance testing has shown that the products are… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no 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.
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 PANBIO West Nile Virus IgM Capture ELISA is for the qualitative presumptive detection of IgM antibodies to West Nile virus in serum as an aid in the clinical laboratory diagnosis of West Nile virus infection in patients with clinical symptoms consistent with encephalitis / meningitis. Positive results must be confirmed by plaque reduction neutralization test (PRNT), or by using the current Centers for Disease Control and Prevention (CDC) guidelines for diagnosis of this disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041231 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041231: West Nile Virus Igm Capture Elisa, Model E-WNV02M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041231
Report an extraction error
Are you the manufacturer?
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