510(k) · Cleared

Cleared

Directigen Respiratory Syncytial Virus Test Kit

K882629510(k) TraditionalCleared Oct 31, 1988126-day reviewClass I21 CFR 866.3480

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

Bd Becton Dickinson Vacutainer Systems Preanalytic · GQG Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

Cleared on Oct 31, 1988 after a 126-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 15 later devices descend from it.

Decided: Oct 31, 1988
Review: 126 days
Class: Class I
Product code: GQG
Recalls: None
Predicates: 0

15 later devices descend from it, 4 citing it directly.

This deviceK882629 Directigen Respiratory Syncytial Virus Test KitBd Becton Dickinson Vacutainer Systems Preanalytic · 1988
Descendant · cites it directly · 11 of its ownK022133 BD Directigen EZ RSV KitBecton, Dickinson & CO · 2002 · Recalled
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

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2002high 3 (2002) · low 0 (2005)2026

Most influential descendants

Showing 5 of 15 · See all

K022133BD Directigen EZ RSV KitBecton, Dickinson & CO · 2002 · cites it directly11descendants
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

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K882629	Directigen Respiratory Syncytial Virus Test Kit	Bd Becton Dickinson Vacutainer Systems Preanalytic	1988	—
+1	K022133	BD Directigen EZ RSV Kit	Becton, Dickinson & CO	2002	1
+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	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	3	0
2003	2	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 K882629, 1988–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (15)

See all 15

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

Number	Device	Applicant	Decided	Descendants
K022133	BD Directigen EZ RSV Kit	Becton, Dickinson & CO	2002	11
K032166	Binax Now RSV Test, Model 430-000 and Binax Now Nasopharyngeal Swab Accessory Pack…	Binax, Inc.	2003	9
K021172	RSV Oia	Thermo Biostar, Inc.	2002	3
K021789	Quicklab RSV	Integrated Biotechnology Corp.	2002	0

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K022133 (Becton, Dickinson & CO, 2002) has gone furthest, with 11 descendants of its own.

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	—

https://510kreport.com/device/K882629 · printed Nov 6, 2026

Cite this page

510(k) Report. “K882629: Directigen Respiratory Syncytial Virus Test Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K882629

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026