(114 days)
The Binax NOW® RSV Test is a rapid immunochromatographic assay for the qualitative detection of respiratory syncytial virus (RSV) fusion protein antigen in nasal wash specimens from symptomatic patients. This test is intended for in vitro diagnostic use to aid in the diagnosis of respiratory syncytial virus infections in neonatal and pediatric patients under the age of five. It is recommended that negative test results be confirmed by cell culture.
Not Found
The provided text only contains an FDA 510(k) clearance letter for the Binax NOW® RSV Test. This letter confirms substantial equivalence to a predicate device and outlines regulatory information. It does not contain details about specific acceptance criteria for performance, nor does it describe a study proving the device meets such criteria.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval rather than technical study details.
§ 866.3480 Respiratory syncytial virus serological reagents.
(a)
Identification. Respiratory syncytial virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to respiratory syncytial virus in serum. Additionally, some of these reagents consist of respiratory syncytial virus antisera conjugated with a fluorescent dye (immunofluorescent reagents) and used to identify respiratory syncytial viruses from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of respiratory syncytial virus infections and provides epidemiological information on diseases caused by these viruses. Respiratory syncytial viruses cause a number of respiratory tract infections, including the common cold, pharyngitis, and infantile bronchopneumonia.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.