510(k) Report

510(k) · Cleared

Cleared

Quickvue Influenza a + B Test

K053146510(k) TraditionalCleared Dec 14, 200534-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

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

Cleared on Dec 14, 2005 as substantially equivalent to K031899 (Quidel Corp., 2003) and 1 other predicate after a 34-day review. Its family tree reaches back 4 generations to 1990. 27 later devices descend from it.

Decided
Dec 14, 2005
Review
34 days
Class
Class II
Product code
PSZ
Recalls
None
Predicates
2

Its longest line of descent runs back 4 generations to K902609 (1990). 6 ancestors in all. 27 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor2000: 1 other ancestor2009: 2 descendants cleared2010: 1 descendant cleared2012: 2 descendants cleared2011: 1 descendant cleared2015: 4 descendants cleared2016: 2 descendants cleared2013: 6 descendants cleared2018: 2 descendants cleared2023: 2 descendants cleared2017: 2 descendants cleared2020: 1 descendant cleared2025: 1 descendant cleared2026: 1 descendant clearedK902609 · 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. · 20031990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor 1 generation forward: 6 descendants2 generations forward: 14 descendants3 generations forward: 3 descendants4 generations forward: 3 descendants5 generations forward: 1 descendant K031899 · 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 · 19900+5
  1. Root · 4 generations backK902609 Directigen Flu aBd Becton Dickinson Vacutainer Systems Preanalytic · 1990
  2. 3 generations backK981651 AB Flu OiaBiostar, Inc. · 1998
  3. 2 generations backK023556 Flu Oia a/B Test KitThermo Biostar, Inc. · 2003 · Recalled
  4. 1 generation backK031899 Quickvue Influenza a+B TestQuidel Corp. · 2003
  5. This deviceK053146 Quickvue Influenza a + B TestQuidel Corp. · 2005
  6. Descendant · cites it directly · 24 of its ownK092698 Quickvue Influenza a+B TestQuidel Corp. · 2009
  7. Descendant · cites it directly · 20 of its ownK112277 BD Veritor (TM) System for Rapid Detection of Flu a+BBecton, Dickinson and Company · 2011 · Recalled
  8. Descendant · 2 generations on · 19 of its ownK132259 BD Veritor System for the Rapid Detection of Flu a+BBecton, Dickinson and Company · 2013
  9. Descendant · 2 generations on · 17 of its ownK132692 BD Veritor System for the Rapid Detection of Flu a+BBecton, Dickinson and Company · 2013
  10. Descendant · 2 generations on · 11 of its ownK151291 BD Veritor (TM) System for the Rapid Detection of Flu A+BBecton, Dickinson and Company · 2015

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

2009: 22010: 12011: 12012: 22013: 62015: 42016: 22017: 22018: 22020: 12023: 22025: 12026: 1
2009high 6 (2013) · low 0 (2014)2026

Most influential descendants

Showing 5 of 27 · See all
  • K092698Quickvue Influenza a+B TestQuidel Corp. · 2009 · cites it directly24descendants
  • K112277BD Veritor (TM) System for Rapid Detection of Flu a+BBecton, Dickinson and Company · 2011 · cites it directly20descendants
  • K132259BD Veritor System for the Rapid Detection of Flu a+BBecton, Dickinson and Company · 2013 · 2 generations on19descendants
  • K132692BD Veritor System for the Rapid Detection of Flu a+BBecton, Dickinson and Company · 2013 · 2 generations on17descendants
  • K151291BD Veritor (TM) System for the Rapid Detection of Flu A+BBecton, Dickinson and Company · 2015 · 2 generations on11descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K902609Directigen Flu aBd Becton Dickinson Vacutainer Systems Preanalytic1990—
−3K981651AB Flu OiaBiostar, Inc.1998—
−2K023556Flu Oia a/B Test KitThermo Biostar, Inc.20031
−1K031899Quickvue Influenza a+B TestQuidel Corp.2003—
0 (this device)K053146Quickvue Influenza a + B TestQuidel Corp.2005—
+1K092698Quickvue Influenza a+B TestQuidel Corp.2009—
+1K112277BD 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—
+2K132692BD Veritor System for the Rapid Detection of Flu a+BBecton, Dickinson and Company2013—
+2K151291BD Veritor (TM) System for the Rapid Detection of Flu A+BBecton, Dickinson and Company2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200920
201010
201110
201220
201360
201540
201620
201720
201820
202010
202320
202510
202610
FIG. 1 — Lineage of K053146, 1990–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 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. #1 K252283 Nano-Check Influenza A+B Testscore 14.9 · 15 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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
*K031899Quickvue Influenza a+B Test
Summary page 1
…kVue® Influenza A + B test Common Name: Influenza test Predicate Devices: Quidel QuickVue® Influenza A+B test (K031899) Quidel OuickVue® Influenza test (K991633) Device Classification/Name: 21 CFR 866.3330 / Influe…
Quidel Corp.2003—
*K991633Quickvue Influenza a/B Test
Summary page 1
…Predicate Devices: Quidel QuickVue® Influenza A+B test (K031899) Quidel OuickVue® Influenza test (K991633) Device Classification/Name: 21 CFR 866.3330 / Influenza virus serological reagents.…
Quidel Corp.1999—

Also cleared against K031899: 3 other devices →

What descends from it? (27)

See all 27

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

NumberDeviceApplicantDecidedDescendants
K092698Quickvue Influenza a+B TestQuidel Corp.200924
K112277BD Veritor (TM) System for Rapid Detection of Flu a+BBecton, Dickinson and Company201120
K121797BD Veritor (TM) System for Rapid Detection of Flu a+BBecton, Dickinson and Company20126
K120049BD Veritor System for the Rapid Detection of Flu a+BBecton, Dickinson and Company20126
K083746Biosign Flu a+BPrinceton BioMeditech Corp.20100
K083278Avc a/H5N1 Flu TestArbor Vita Corportation20090

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 15 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
  • 1 of the 6 ancestors has a recall of any class.
  • Of its descendants, K092698 (Quidel Corp., 2009) has gone furthest, with 24 descendants of its own.
  • 3 other devices also cite its predicate K031899.

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

2007: 22008: 12009: 72010: 52011: 32012: 22013: 82014: 12015: 42016: 32017: 32018: 52020: 22023: 22025: 22026 (partial year): 2
2007high 8 (2013) · low 0 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PSZ

28in 2018

2009: 20 days median2010: 29 days median2011: 80 days median2013: 28 days median2015: 27 days median2016: 29 days median2017: 200 days median2018: 28 days median
2007high 200 (2017) · low 20 (2009)2026

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

Recalls per year · PSZ

1in 2022

2020: 12022: 1
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

2018: 12019: 12020: 52021: 422022: 102023: 122024: 162025: 60
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—00
20081—00
200972000
201052900
201138000
20122—00
201382800
20141—00
201542700
201632900
2017320000
201852801
20190—01
20202—15
20210—042
20220—110
20232—012
20240—016
20252—060
20262—0—

What is it indicated for?

The QuickVue Influenza A + B test allows for the rapid, qualitative detection of influenza type A and type B antigens directly from nasal swab, nasopharyngeal swab, nasal wash and/or nasal aspirate specimens. The test is intended for use as an aid in the rapid differential diagnosis of acute influenza type A and type B viral infections. The test is not intended to detect influenza C antigens. Negative test results should be confirmed by cell culture. The test is intended for professional and laboratory use.

Indications for use as stated in the FDA summary.

Also cleared against K031899

3 other devices cite the same predicate.

  • K092698Quickvue Influenza a+B TestQuidel Corp. · 2009
  • K051244Genzyme Osom Influenza a & B TestGenzyme Corp. · 2006
  • K041626Immunocard Stat! Flu a & BMeridian Bioscience, Inc. · 2005

More from Quidel Corp.

95 FDA decisions under this applicant name. See the company

  • K131813Quidel Molecular RSV + HMPV AssayQuidel Corp. · 2013
  • K131728Quidel Molecular Influenza a + B AssayQuidel Corp. · 2013
  • K130398Sofia (R) RSV FiaQuidel Corp. · 2013
  • K131166Sofia (R) HCG FiaQuidel Corp. · 2013
  • K131606Sofia Influenza a+B FiaQuidel Corp. · 2013

Recent decisions in PSZ

The PSZ category page

  • K254262Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIAOrtho Clinical Diagnostics Inc. (QuidelOrtho) · 2026
  • K252283Nano-Check Influenza A+B TestNano-Ditech Corporation · 2026
  • K250398Innovita Flu A/B Antigen Rapid TestInnovita (Tangshan) Biological Technology Co., Ltd. · 2025
  • K241188Acucy® Influenza A&B Test with the Acucy® 2 SystemSEKISUI Diagnostics, LLC · 2025
  • K232434BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived KitBd · 2023

https://510kreport.com/device/K053146 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053146: Quickvue Influenza a + B Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053146

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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