# Medical Devices; Immunology and Microbiology Devices; Classification of the West Nile Virus IgM Capture Elisa Assay
> **Food and Drug Administration** · Final rule. · Published 2003-10-30 · Effective 2003-12-01 · 68 FR 61743
## Document
- **Document number:** 03-27294
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 68 FR 61743
- **CFR reference:** 21 CFR 866
- **Publication date:** 2003-10-30
- **Effective date:** 2003-12-01
- **HHS docket:** Docket No. 2003P-0450
## Abstract

The Food and Drug Administration (FDA) is classifying the West Nile Virus IgM Capture Elisa assay into class II (special controls). The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997 (FDAMA). The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for the device.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2003/10/30/03-27294/medical-devices-immunology-and-microbiology-devices-classification-of-the-west-nile-virus-igm)
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