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U.S. Department of Health and Human Services

Product Classification

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Device norovirus serological reagent
Regulation Description Norovirus serological reagents.
Definition Norovirus serological reagents are devices that consist of antigens and antisera for the detection of anti-norovirus antibodies or norovirus antigens. The detection aids in the clinical laboratory diagnosis of norovirus infection in individuals with signs and/or symptoms of acute gastroenteritis, or in the determining the etiology of acute gastroenteritis outbreaks.
Physical State Laboratory kit.
Technical Method ELISA-based or immunological based assays.
Target Area Human biological specimens.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeOUC
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Division of Microbiology Devices (DMD)
Submission Type 510(K) Exempt
Regulation Number 866.3395
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
    Note: Class II devices the Food and Drug Administration (FDA) has also published a list of class II (special controls) devices subject to certain limitations, that are exempt from premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the 21st Century Cures Act of 2016 (Cures Act). FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues. FDA is taking this action in order to meet requirements of FDAMA and the Cures Act.
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible