# K031952: West Nile Virus Igm Capture Elisa, Model EL0300M

- Pathway: 510(k) (Traditional)
- Applicant: Focus Technologies, Inc.
- Decided: Oct 22, 2003 after 119 days
- Product code: NOP (Elisa, Antibody, West Nile Virus)
- Device class: 2
- Regulation: 21 CFR 866.3940
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K993724 (2000). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993724: HSV-2 Elisa Igg, Model EL0920G, Mrl Diagnostics (2000) Summary page 1.
- (no number) Focus Technologies Arbovirus IFA IgM: named in the summary without a submission number
- (no number) CDC West Nile Virus IgM Capture ELISA: named in the summary without a submission number
- (no number) West Nile Virus Plaque-Reduction Neutralization Test: named in the summary without a submission number

## Most influential descendants
- K040854: West Nile Virus Igm Capture Elisa (2004), 1 descendant of its own
- K153308: EUROIMMUN Anti-West Nile Virus ELISA (IgM) (2016), 0 descendants of its own
- K052519: Spectral West Nile Virus Igm Status Test (2006), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K031952
Methodology: https://510kreport.com/methodology