# K052519: Spectral West Nile Virus Igm Status Test

- Pathway: 510(k) (Traditional)
- Applicant: Spectral Diagnostics, Inc.
- Decided: Nov 30, 2006 after 442 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: 2 generations back to K993724 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031952: West Nile Virus Igm Capture Elisa, Model EL0300M, Focus Technologies, Inc. (2003) Summary page 1.

## Indications for use
The Spectral West Nile virus IgM STATusTM test is a rapid immunochromatographic lateral flow assay that utilizes recombinant West Nile virus (WNV) antigen (E glycoprotein) for the qualitative detection of IgM antibodies to WNV in human serum or plasma (sodium heparin or sodium citrate). This test is for the presumptive laboratory diagnosis of West Nile virus infection in patients having signs and symptoms of meningoencephalitis. Positive results must be confirmed by the PRNT (Plaque Neutralization Reduction Test), or by using the current CDC guidelines for diagnosis of this disease. The Spectral test is not intended for point of care testing, home use or in screening blood donor samples.

Source page: https://510kreport.com/device/K052519
Methodology: https://510kreport.com/methodology