# K041817: West Nile Detect Igm Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Inbios Intl., Inc.
- Decided: Nov 19, 2004 after 136 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The West Nile Detect IgM Capture ELISA is for the qualitative detection of IgM antibodies to WNV recombinant antigens (WNRA) in serum for the presumptive clinical laboratory diagnosis of West Nile virus infection in patients with clinical symptoms consistent with meningoencephalitis. Positive results must be confirmed by Plaque Reduction Neutralization Test (PRNT), or by using the current CDC guidelines for diagnosis of this disease. Assay performance characteristics have not been established for testing cord blood, neonate, prenatal screening, general population screening without symptoms of meningoencephalitis or automated instruments. This assay is not cleared or approved for testing blood or plasma donors.

Source page: https://510kreport.com/device/K041817
Methodology: https://510kreport.com/methodology