# K031953: West Nile Virus Elisa Igg, Model EL0300G

- 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K913617 (1992). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913617: Arbovirus Igg Ifa Test, Hillcrest Biologicals (1992) Summary page 1.
- K993724: HSV-2 Elisa Igg, Model EL0920G, Mrl Diagnostics (2000) Summary page 1.
- (no number) CDC West Nile Virus IgG 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
- K153303: EUROIMMUN Anti-West Nile Virus ELISA (IgG) (2016), 0 descendants of its own

## Recalls of this device
- Oct 3, 2012 · Class III · Z-0182-2013: The firm recalled due to higher reactivity with some samples in the effected lots, which may reflect a higher false positive rate.

## Indications for use
The Focus Technologies West Nile Virus ELISA IgG is intended for qualitatively detecting IgG antibodies to West Nile virus in human serum. In conjunction with the Focus Technologies West Nile Virus IgM Capture ELISA, the test is indicated for testing persons having symptoms of meningioencephalitis, 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/K031953
Methodology: https://510kreport.com/methodology