# K032166: Binax Now RSV Test, Model 430-000 and Binax Now Nasopharyngeal Swab Accessory Pack, Model 400-065

- Pathway: 510(k) (Traditional)
- Applicant: Binax, Inc.
- Decided: Oct 21, 2003 after 97 days
- Product code: GQG (Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus)
- Device class: 1
- Regulation: 21 CFR 866.3480
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K882629 (1988). 2 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022133: BD Directigen EZ RSV Kit, Becton, Dickinson & CO (2002) Summary page 2.
- K882629: Directigen Respiratory Syncytial Virus Test Kit, Bd Becton Dickinson Vacutainer Systems Preanalytic (1988) Summary page 2.

## Most influential descendants
- K061008: Quickvue RSV (20 Test Kit), Model 20193; (2 Test Kit), Model 20199 (2006), 6 descendants of its own
- K070747: Quick Vue RSV Test, Models 20193, 20199 (2007), 5 descendants of its own
- K101918: Quickvue RSV 10 (2010), 4 descendants of its own
- K121633: BD Veritor (TM) System for the Rapid Detection of RSV (2012), 2 descendants of its own
- K130398: Sofia (R) RSV Fia (2013), 1 descendant of its own

## Recalls of this device
- Mar 28, 2007 · Not classified · Z-0824-2007: Tip of the foam swab could detach from the shaft causing injury to the patient.
- Feb 18, 2004 · Not classified · Z-0778-04: Pouch integrity compromised

## 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 and nasopharyngeal swab specimens from symptomatic patients. This test is intended for in vitro diagnostic use to aid in the diagnosis of RSV infections in neonatal and pediatric patients under the age of five. It is recommended that negative test results be confirmed by culture.

Source page: https://510kreport.com/device/K032166
Methodology: https://510kreport.com/methodology