OUC · Norovirus Serological Reagent

Microbiology · 21 CFR 866.3395 · Class 2

Overview

Identification

Norovirus serological reagents are devices that consist of antigens and antisera used in serological tests to detect the presence of norovirus antigens in fecal samples. These devices aid in the diagnosis of norovirus infection in the setting of an individual patient with symptoms of acute gastroenteritis when the individual patient is epidemiologically linked to other patients with symptoms of acute gastroenteritis and/or aid in the identification of norovirus as the etiology of an outbreak of acute gastroenteritis in the setting of epidemiologically linked patients with symptoms of acute gastroenteritis.

Classification Rationale

Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9. The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Norovirus Serological Reagents.” See § 866.1(e) for the availability of this guidance document.

Special Controls

The device is classified as Class II under regulation 21 CFR 866.3395 with special controls. The special control guidance document "Class II Special Controls Guidance Document: Immunoassay or Antigen Detection-based In Vitro Diagnostic Devices for Norovirus Detection" will be available shortly.

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9. The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Norovirus Serological Reagents.” See § 866.1(e) for the availability of this guidance document.

Recent Cleared Devices (1 of 1)

Top Applicants

• R-Biopharm AG — 1 clearance