# K153308: EUROIMMUN Anti-West Nile Virus ELISA (IgM)

- Pathway: 510(k) (Traditional)
- Applicant: Euroimmun Us, Inc.
- Decided: Aug 12, 2016 after 269 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: 3 generations back to K993724 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040854: West Nile Virus Igm Capture Elisa, Focus Technologies, Inc. (2004) Summary page 5.

## Indications for use
The EUROIMMUN Anti-West Nile Virus ELISA (IgM) is intended for the qualitative detection of IgM antibodies to West Nile virus in human serum and plasma (K+-EDTA, Li+-heparin). This test is intended as an aid in the presumptive laboratory diagnosis of West Nile virus infection in patients with clinical symptoms consistent with meningitis/encephalitis, in conjunction with other laboratory and clinical findings. Positive results must be confirmed by the plaque reduction neutralization test (PRNT) or by using the current CDC guidelines for diagnosis of this disease. The assay characteristics have not been established for testing cord blood, neonates, prenatal screening, and general population screening of patients without symptoms of meningoencephalitis. This assay is not FDA cleared or approved for testing blood or plasma donors. Warning: Cross-reactivity with IgM to Dengue virus, Malaria/anti-Plasmodium falciparum and Parvovirus B19 has been observed with the EUROIMMUN Anti-West Nile Virus ELISA (IgM). Reactive results must be reported with a caution statement regarding possible IgM cross-reactivity with other flaviviruses.

Source page: https://510kreport.com/device/K153308
Methodology: https://510kreport.com/methodology