# Microbiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices
> **Food and Drug Administration** · Final amendment; final order. · Published 2025-09-18 · Effective 2025-10-20 · 90 FR 44969
## Document
- **Document number:** 2025-18082
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 90 FR 44969
- **CFR reference:** 21 CFR 866
- **Publication date:** 2025-09-18
- **Effective date:** 2025-10-20
- **HHS docket:** Docket No. FDA-2024-N-3533
## Abstract

The Food and Drug Administration (FDA) is issuing a final order reclassifying qualitative hepatitis B virus (HBV) antigen assays (product code LOM), HBV antibody assays (product code LOM), and quantitative HBV nucleic acid-based assays (product code MKT), all of which are postamendments class III devices, into class II (special controls), subject to premarket notification. FDA is also establishing the special controls that are necessary to provide a reasonable assurance of safety and effectiveness of these device types.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2025/09/18/2025-18082/microbiology-devices-reclassification-of-antigen-antibody-and-nucleic-acid-based-hepatitis-b-virus)
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