# K022133: BD Directigen EZ RSV Kit

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Dec 10, 2002 after 162 days
- Product code: GQG (Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus)
- Device class: 1
- Regulation: 21 CFR 866.3480
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K882629 (1988). 1 ancestor in all.
11 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K882629: Directigen Respiratory Syncytial Virus Test Kit, Bd Becton Dickinson Vacutainer Systems Preanalytic (1988) Summary page 1.
- (no number) Cell Culture: named in the summary without a submission number
- (no number) Direct Fluorescent Antibody (DFA): named in the summary without a submission number

## Most influential descendants
- K032166: Binax Now RSV Test, Model 430-000 and Binax Now Nasopharyngeal Swab Accessory Pack, Model 400-065 (2003), 9 descendants of its own
- 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

## Recalls of this device
- Dec 15, 2003 · Not classified · Z-0373-04: Diagnostic test kit may exhibit false positive results.

## Indications for use
The BD Directigen™ EZ RSV test is a rapid chromatographic immunoassay for the direct and qualitative detection of Respiratory Syncytial Virus (RSV) antigen in nasopharyngeal washes, nasopharyngeal aspirates, nasopharyngeal swabs, and nasopharyngeal swab/washes from patients suspected of having a viral respiratory infection. 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 20. It is recommended that negative test results be confirmed by cell culture.

Source page: https://510kreport.com/device/K022133
Methodology: https://510kreport.com/methodology