510(k) · Cleared

Cleared

BD Directigen Flu a+B

K001364510(k) TraditionalCleared Jun 28, 200058-day reviewClass II21 CFR 866.3328

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 · PSZ Devices Detecting Influenza A, B, And C Virus Antigens

Cleared on Jun 28, 2000 after a 58-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 46 later devices descend from it.

Decided: Jun 28, 2000
Review: 58 days
Class: Class II
Product code: PSZ
Recalls: None
Predicates: 0

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

This deviceK001364 BD Directigen Flu a+BBd Becton Dickinson Vacutainer Systems Preanalytic · 2000
Descendant · cites it directly · 34 of its ownK031899 Quickvue Influenza a+B TestQuidel Corp. · 2003
Descendant · 2 generations on · 27 of its ownK053146 Quickvue Influenza a + B TestQuidel Corp. · 2005
Descendant · 2 generations on · 24 of its ownK092698 Quickvue Influenza a+B TestQuidel Corp. · 2009
Descendant · 3 generations on · 20 of its ownK112277 BD Veritor (TM) System for Rapid Detection of Flu a+BBecton, Dickinson and Company · 2011 · Recalled
Descendant · 4 generations on · 19 of its ownK132259 BD Veritor System for the Rapid Detection of Flu a+BBecton, Dickinson and Company · 2013

Showing 5 of 46 descendants. See all descendants

Descendants cleared per year

2003high 8 (2013) · low 0 (2004)2026

Most influential descendants

Showing 5 of 46 · See all

K031899Quickvue Influenza a+B TestQuidel Corp. · 2003 · cites it directly34descendants
K053146Quickvue Influenza a + B TestQuidel Corp. · 2005 · 2 generations on27descendants
K092698Quickvue Influenza a+B TestQuidel Corp. · 2009 · 2 generations on24descendants
K112277BD Veritor (TM) System for Rapid Detection of Flu a+BBecton, Dickinson and Company · 2011 · 3 generations on20descendants
K132259BD Veritor System for the Rapid Detection of Flu a+BBecton, Dickinson and Company · 2013 · 4 generations on19descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K001364	BD Directigen Flu a+B	Bd Becton Dickinson Vacutainer Systems Preanalytic	2000	—
+1	K031899	Quickvue Influenza a+B Test	Quidel Corp.	2003	—
+2	K053146	Quickvue Influenza a + B Test	Quidel Corp.	2005	—
+2	K092698	Quickvue Influenza a+B Test	Quidel Corp.	2009	—
+3	K112277	BD Veritor (TM) System for Rapid Detection of Flu a+B	Becton, Dickinson and Company	2011	1
+4	K132259	BD Veritor System for the Rapid Detection of Flu a+B	Becton, Dickinson and Company	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2005	2	0
2006	3	0
2007	2	0
2008	1	0
2009	5	0
2010	4	0
2011	2	0
2012	3	0
2013	8	0
2015	4	0
2016	2	0
2017	2	0
2018	2	0
2020	1	0
2023	2	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K001364, 2000–2026Source: 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 PSZ? 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 PSZ device

#1 K252283 Nano-Check Influenza A+B Testscore 14.9 · 15 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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? (46)

See all 46

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

Number	Device	Applicant	Decided	Descendants
K031899	Quickvue Influenza a+B Test	Quidel Corp.	2003	34
K062109	Binaxnow Influenza a & B Test	Binax, Inc.	2006	8
K063689	BD Directigen EZ Flu a+B Test	Becton, Dickinson & CO	2007	2
K041626	Immunocard Stat! Flu a & B	Meridian Bioscience, Inc.	2005	1

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, K031899 (Quidel Corp., 2003) has gone furthest, with 34 descendants of its own.

How does its category compare?

All PSZ devices

PSZ Devices Detecting Influenza A, B, And C Virus Antigens: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · PSZ

2in 2025

2007high 8 (2013) · low 0 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PSZ

28in 2018

2007high 200 (2017) · low 20 (2009)2026

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

Recalls per year · PSZ

1in 2022

2007high 1 (2020) · low 0 (2007)2026

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

Adverse event reports per year · PSZ

60in 2025

2007high 60 (2025) · low 0 (2007)2025

MAUDE reports naming product code PSZ, 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	2	—	0	0
2008	1	—	0	0
2009	7	20	0	0
2010	5	29	0	0
2011	3	80	0	0
2012	2	—	0	0
2013	8	28	0	0
2014	1	—	0	0
2015	4	27	0	0
2016	3	29	0	0
2017	3	200	0	0
2018	5	28	0	1
2019	0	—	0	1
2020	2	—	1	5
2021	0	—	0	42
2022	0	—	1	10
2023	2	—	0	12
2024	0	—	0	16
2025	2	—	0	60
2026	2	—	0	—

https://510kreport.com/device/K001364 · printed Nov 5, 2026

Cite this page

510(k) Report. “K001364: BD Directigen Flu a+B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K001364

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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