# K041068: West Nile Virus Igg Indirect Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Panbio Limited
- Decided: Oct 20, 2004 after 177 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. The FDA summary names no predicate by number.

## Indications for use
The PANBIO West Nile Virus IgG Indirect ELISA is for the qualitative presumptive detection of IgG antibodies to West Nile virus in serum. In conjunction with the PANBIO West Nile Virus IgM Capture ELISA, this test is intended 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/K041068
Methodology: https://510kreport.com/methodology