# K021687: Binax Now RSV Test (27 Test), Binax Now Nasopharyngeal Swab Specimen Accessory Pack

- Pathway: 510(k) (Traditional)
- Applicant: Binax, Inc.
- Decided: Sep 13, 2002 after 114 days
- Product code: GQG (Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus)
- Device class: 1
- Regulation: 21 CFR 866.3480
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
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.

Source page: https://510kreport.com/device/K021687
Methodology: https://510kreport.com/methodology