510(k) Report

510(k) · Cleared

Cleared

BD Veritor System for the Rapid Detection of RSV

K133140510(k) SpecialCleared Nov 15, 201329-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

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

Cleared on Nov 15, 2013 as substantially equivalent to K120049 (Becton, Dickinson and Company, 2012) and 3 other predicates after a 29-day review. Its family tree reaches back 9 generations to 1990.

Decided
Nov 15, 2013
Review
29 days
Class
Class I
Product code
GQG
Recalls
None
Predicates
4

Its longest line of descent runs back 9 generations to K902609 (1990). 14 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2013: 1 other ancestor2012: 2 other ancestors1999: 1 other ancestor2000: 1 other ancestorK902609 · Directigen Flu a · Bd Becton Dickinson Vacutainer Systems Preanalytic · 1990K981651 · AB Flu Oia · Biostar, Inc. · 1998K023556 · Flu Oia a/B Test Kit · Thermo Biostar, Inc. · 2003 · recalledK031899 · Quickvue Influenza a+B Test · Quidel Corp. · 2003K053146 · Quickvue Influenza a + B Test · Quidel Corp. · 2005K092698 · Quickvue Influenza a+B Test · Quidel Corp. · 2009K112277 · BD Veritor (TM) System for Rapid Detection of Flu a+B · Becton, Dickinson and Company · 2011 · recalled×2: 2 generations cleared close together, K132259 (2013), K132692 (2013) 199019952000200520102015
Other ancestors, by generation 1 generation back: 3 other ancestors3 generations back: 1 other ancestor4 generations back: 1 other ancestor K132692 · BD Veritor System for the Rapid Detection of Flu a+B · Becton, Dickinson and Company · 2013K132259 · BD Veritor System for the Rapid Detection of Flu a+B · Becton, Dickinson and Company · 2013K112277 · BD Veritor (TM) System for Rapid Detection of Flu a+B · Becton, Dickinson and Company · 2011 · recalledK092698 · Quickvue Influenza a+B Test · Quidel Corp. · 2009K053146 · Quickvue Influenza a + B Test · Quidel Corp. · 2005K031899 · Quickvue Influenza a+B Test · Quidel Corp. · 2003K023556 · Flu Oia a/B Test Kit · Thermo Biostar, Inc. · 2003 · recalledK981651 · AB Flu Oia · Biostar, Inc. · 1998K902609 · Directigen Flu a · Bd Becton Dickinson Vacutainer Systems Preanalytic · 1990−50
  1. Root · 9 generations backK902609 Directigen Flu aBd Becton Dickinson Vacutainer Systems Preanalytic · 1990
  2. 5 generations between
  3. 3 generations backK112277 BD Veritor (TM) System for Rapid Detection of Flu a+BBecton, Dickinson and Company · 2011 · Recalled
  4. 2 generations backK132259 BD Veritor System for the Rapid Detection of Flu a+BBecton, Dickinson and Company · 2013
  5. 1 generation backK132692 BD Veritor System for the Rapid Detection of Flu a+BBecton, Dickinson and Company · 2013
  6. This deviceK133140 BD Veritor System for the Rapid Detection of RSVBecton, Dickinson & CO · 2013
Show all 9 generations
  1. Root · 9 generations backK902609 Directigen Flu aBd Becton Dickinson Vacutainer Systems Preanalytic · 1990
  2. 8 generations backK981651 AB Flu OiaBiostar, Inc. · 1998
  3. 7 generations backK023556 Flu Oia a/B Test KitThermo Biostar, Inc. · 2003 · Recalled
  4. 6 generations backK031899 Quickvue Influenza a+B TestQuidel Corp. · 2003
  5. 5 generations backK053146 Quickvue Influenza a + B TestQuidel Corp. · 2005
  6. 4 generations backK092698 Quickvue Influenza a+B TestQuidel Corp. · 2009
  7. 3 generations backK112277 BD Veritor (TM) System for Rapid Detection of Flu a+BBecton, Dickinson and Company · 2011 · Recalled
  8. 2 generations backK132259 BD Veritor System for the Rapid Detection of Flu a+BBecton, Dickinson and Company · 2013
  9. 1 generation backK132692 BD Veritor System for the Rapid Detection of Flu a+BBecton, Dickinson and Company · 2013
  10. This deviceK133140 BD Veritor System for the Rapid Detection of RSVBecton, Dickinson & CO · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K902609Directigen Flu aBd Becton Dickinson Vacutainer Systems Preanalytic1990—
−8K981651AB Flu OiaBiostar, Inc.1998—
−7K023556Flu Oia a/B Test KitThermo Biostar, Inc.20031
−6K031899Quickvue Influenza a+B TestQuidel Corp.2003—
−5K053146Quickvue Influenza a + B TestQuidel Corp.2005—
−4K092698Quickvue Influenza a+B TestQuidel Corp.2009—
−3K112277BD Veritor (TM) System for Rapid Detection of Flu a+BBecton, Dickinson and Company20111
−2K132259BD Veritor System for the Rapid Detection of Flu a+BBecton, Dickinson and Company2013—
−1K132692BD Veritor System for the Rapid Detection of Flu a+BBecton, Dickinson and Company2013—
0 (this device)K133140BD Veritor System for the Rapid Detection of RSVBecton, Dickinson & CO2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
200010
201220
201310
FIG. 1 — Lineage of K133140, 1990–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #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? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K120049BD Veritor System for the Rapid Detection of Flu a+B
Summary page 1
…21 CFR 866.3330 PREDICATE DEVICES: BID VeritorTM System for Rapid Detection of Flu A+B POC (k120049, k121797, k132256, k132692) INTENDED USE: Clinical Kit The BD Veritor TM System for Rapid Detection of Flu A-IB is a rapid chr…
Becton, Dickinson and Company2012—
*K121797BD Veritor (TM) System for Rapid Detection of Flu a+B
Summary page 1
…21 CFR 866.3330 PREDICATE DEVICES: BID VeritorTM System for Rapid Detection of Flu A+B POC (k120049, k121797, k132256, k132692) INTENDED USE: Clinical Kit The BD Veritor TM System for Rapid Detection of Flu A-IB is a rapid chromatograp…
Becton, Dickinson and Company2012—
*K132256BD Veritor System for the Rapid Detection of Flu a+B
Summary page 1
…66.3330 PREDICATE DEVICES: BID VeritorTM System for Rapid Detection of Flu A+B POC (k120049, k121797, k132256, k132692) INTENDED USE: Clinical Kit The BD Veritor TM System for Rapid Detection of Flu A-IB is a rapid chromatographic immun…
Becton, Dickinson and Company2013—
*K132692BD Veritor System for the Rapid Detection of Flu a+B
Summary page 1
…PREDICATE DEVICES: BID VeritorTM System for Rapid Detection of Flu A+B POC (k120049, k121797, k132256, k132692) INTENDED USE: Clinical Kit The BD Veritor TM System for Rapid Detection of Flu A-IB is a rapid chromatographic immunoassay fo…
Becton, Dickinson and Company2013—

Also cleared against K120049: 5 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • The line of descent spans 23 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
  • 2 of the 14 ancestors have a recall of any class.
  • 5 other devices also cite its predicate K120049.

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. 2013, this device’s year, is highlighted.

FDA decisions per year · GQG

1in 2024

2007: 12009: 12010: 22012: 12013: 32017: 12024: 12026 (partial year): 1
2007high 3 (2013) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GQG

93in 2013

2013: 93 days median
2007high 93 (2013)2026

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

Recalls per year · GQG

1in 2007

2007: 1
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

2009: 12018: 12020: 12021: 52022: 32023: 62024: 22025: 2
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—10
20080—00
20091—01
20102—00
20110—00
20121—00
201339300
20140—00
20150—00
20160—00
20171—00
20180—01
20190—00
20200—01
20210—05
20220—03
20230—06
20241—02
20250—02
20261—0—

What is it indicated for?

The IBD VoritorM System for Rapid Detection of Respiratory Syncytial Virus (RSV) is a chromatographic immunoassay with an instrumented read for the direct and qualitative detection of RSV antigen from nasopharyngeal washes/aspirates and nasopharyngeal swabs in transport media 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…

Read the full statement (147 words)

The IBD VoritorM System for Rapid Detection of Respiratory Syncytial Virus

(RSV) is a chromatographic immunoassay with an instrumented read for the

direct and qualitative detection of RSV antigen from nasopharyngeal

washes/aspirates and nasopharyngeal swabs in transport media 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. Negative results do not preclude RSV Infection and

should not be used as the sole basis for treatment or for other management

decisions. A negative test is presumptive. It is recommended that negative test

results be confirmed by viral cell culture or an alternative method, such as a

FDA-cleared molecular assay. The test is intended for professional and

laboratory use. It is to be used in conjunction with the BD VertorTM System

Reader.

Indications for use as stated in the FDA summary.

Also cleared against K120049

5 other devices cite the same predicate.

  • K160164BD Veritor System for Rapid Detection of Flu A + B Labratory KitBecton, Dickinson & CO · 2016
  • K152874BD Veritor System for the Rapid Detection of Flu A + B Laboratory kitBecton, Dickinson and Co. · 2015
  • K151301BD Veritor™ System Flu A+B AssayBecton, Dickinson and Company · 2015
  • K133138BD Veritor™ System Flu A+B AssayBecton, Dickinson & CO · 2013
  • K132256BD Veritor System for the Rapid Detection of Flu a+BBecton, Dickinson and Company · 2013

More from Becton, Dickinson & CO

190 FDA decisions under this applicant name. See the company

  • K160164BD Veritor System for Rapid Detection of Flu A + B Labratory KitBecton, Dickinson & CO · 2016
  • K160161BD Veritor System for Rapid Detection of Flu A + B CLIA waived kitBecton, Dickinson & CO · 2016
  • K141474Becton Dickinson Intelliport SystemBecton, Dickinson & CO · 20141 recall
  • K140446BD Probetec Chlamydia Trachomatis (CT) QX Amplified Dna AssayBecton, Dickinson & CO · 2014
  • K140448BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified Dna AssayBecton, Dickinson & CO · 2014

Recent decisions in GQG

The GQG category page

  • K253318Clungene RSV Antigen Rapid TestHangzhou Clongene Biotech Co., Ltd. · 2026
  • K240280Nano-Check™ RSV TestNano-Ditech Corporation · 2024
  • K162911Sofia RSV FIA on Sofia 2 analyzerQuidel Corporation · 20171 recall
  • K132456BD Veritor (TM) System for Rapid Detection of RSVBecton, Dickinson and Company · 2013
  • K130398Sofia (R) RSV FiaQuidel Corp. · 2013

https://510kreport.com/device/K133140 · printed Nov 6, 2026

Cite this page

510(k) Report. “K133140: BD Veritor System for the Rapid Detection of RSV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133140

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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