# K041231: West Nile Virus Igm Capture Elisa, Model E-WNV02M

- Pathway: 510(k) (Traditional)
- Applicant: Panbio Limited
- Decided: Aug 10, 2004 after 92 days
- Product code: NOP (Elisa, Antibody, West Nile Virus)
- Device class: 2
- Regulation: 21 CFR 866.3940
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN030004 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN030004: West Nile Virus Igm Capture Elisa, Panbio Limited (2003). 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.

## Recalls of this device
- Oct 8, 2008 · Not classified · Z-1014-2012: 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 h

## Indications for use
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.

Source page: https://510kreport.com/device/K041231
Methodology: https://510kreport.com/methodology