510(k) · Cleared

Recalled · 2003

BD Directigen EZ RSV Kit

K022133510(k) TraditionalCleared Dec 10, 2002162-day reviewClass I21 CFR 866.3480Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Becton, Dickinson & CO · GQG Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

Cleared on Dec 10, 2002 as substantially equivalent to K882629 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1988) after a 162-day review. Its family tree reaches back 1 generation to 1988. 11 later devices descend from it. It has been recalled once.

Decided: Dec 10, 2002
Review: 162 days
Class: Class I
Product code: GQG
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K882629 (1988). 11 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK882629 Directigen Respiratory Syncytial Virus Test KitBd Becton Dickinson Vacutainer Systems Preanalytic · 1988
This deviceK022133 BD Directigen EZ RSV KitBecton, Dickinson & CO · 2002
Descendant · cites it directly · 9 of its ownK032166 Binax Now RSV Test, Model 430-000 and Binax Now Nasopharyngeal Swab…Binax, Inc. · 2003 · Recalled
Descendant · 2 generations on · 6 of its ownK061008 Quickvue RSV (20 Test Kit), Model 20193; (2 Test Kit), Model 20199Quidel Corp. · 2006
Descendant · 3 generations on · 5 of its ownK070747 Quick Vue RSV Test, Models 20193, 20199Quidel Corp. · 2007
Descendant · 3 generations on · 4 of its ownK101918 Quickvue RSV 10Quidel Corp. · 2010
Descendant · 4 generations on · 2 of its ownK121633 BD Veritor (TM) System for the Rapid Detection of RSVBecton, Dickinson and Company · 2012

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2003high 2 (2007) · low 0 (2005)2026

Most influential descendants

Showing 5 of 11 · See all

K032166Binax Now RSV Test, Model 430-000 and Binax Now Nasopharyngeal Swab Accessory Pack…Binax, Inc. · 2003 · cites it directly9descendants
K061008Quickvue RSV (20 Test Kit), Model 20193; (2 Test Kit), Model 20199Quidel Corp. · 2006 · 2 generations on6descendants
K070747Quick Vue RSV Test, Models 20193, 20199Quidel Corp. · 2007 · 3 generations on5descendants
K101918Quickvue RSV 10Quidel Corp. · 2010 · 3 generations on4descendants
K121633BD Veritor (TM) System for the Rapid Detection of RSVBecton, Dickinson and Company · 2012 · 4 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K882629	Directigen Respiratory Syncytial Virus Test Kit	Bd Becton Dickinson Vacutainer Systems Preanalytic	1988	—
0 (this device)	K022133	BD Directigen EZ RSV Kit	Becton, Dickinson & CO	2002	—
+1	K032166	Binax Now RSV Test, Model 430-000 and Binax Now Nasopharyngeal Swab Accessory…	Binax, Inc.	2003	2
+2	K061008	Quickvue RSV (20 Test Kit), Model 20193; (2 Test Kit), Model 20199	Quidel Corp.	2006	—
+3	K070747	Quick Vue RSV Test, Models 20193, 20199	Quidel Corp.	2007	—
+3	K101918	Quickvue RSV 10	Quidel Corp.	2010	—
+4	K121633	BD Veritor (TM) System for the Rapid Detection of RSV	Becton, Dickinson and Company	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	1	0
2006	1	0
2007	2	0
2010	2	0
2012	1	0
2013	2	0
2017	1	0

FIG. 1 — Lineage of K022133, 1988–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GQG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GQG device

#1 K253318 Clungene RSV Antigen Rapid Testscore 10.8 · 1 generation · no Class I recall

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What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K882629	Directigen Respiratory Syncytial Virus Test Kit Summary page 1 …PREDICATE DEVICES: Cell Culture Direct Fluorescent Antibody (DFA) DirectigenTMRSV (K882629) INTENDED USE: The BD DirectigenTMEZ RSV test is a rapid chromatographic immunoassay for the direct and qualitative detection o…	Bd Becton Dickinson Vacutainer Systems Preanalytic	1988	—
*	—	Cell Culture Named without a submission number			—
*	—	Direct Fluorescent Antibody (DFA) Named without a submission number			—

Also cleared against K882629: 3 other devices →

What descends from it? (11)

See all 11

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K032166	Binax Now RSV Test, Model 430-000 and Binax Now Nasopharyngeal Swab Accessory Pack…	Binax, Inc.	2003	9
K041445	Immunocard Stat! RSV Model #750630	Meridian Bioscience, Inc.	2004	1
K101514	BD Directigen EZ RSV	Becton, Dickinson & CO	2010	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 15, 2003	Not classified	Z-0373-04	Other	Diagnostic test kit may exhibit false positive results.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K032166 (Binax, Inc., 2003) has gone furthest, with 9 descendants of its own.
3 other devices also cite its predicate K882629.

How does its category compare?

All GQG devices

GQG Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GQG

1in 2024

2007high 3 (2013) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GQG

93in 2013

2007high 93 (2013)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GQG

1in 2007

2007high 1 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GQG

2in 2025

2007high 6 (2023) · low 0 (2007)2025

MAUDE reports naming product code GQG, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	1	—	1	0
2008	0	—	0	0
2009	1	—	0	1
2010	2	—	0	0
2011	0	—	0	0
2012	1	—	0	0
2013	3	93	0	0
2014	0	—	0	0
2015	0	—	0	0
2016	0	—	0	0
2017	1	—	0	0
2018	0	—	0	1
2019	0	—	0	0
2020	0	—	0	1
2021	0	—	0	5
2022	0	—	0	3
2023	0	—	0	6
2024	1	—	0	2
2025	0	—	0	2
2026	1	—	0	—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K022133 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022133: BD Directigen EZ RSV Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022133

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026