510(k) Report

510(k) · Cleared

Cleared

Quickvue RSV (20 Test Kit), Model 20193; (2 Test Kit), Model 20199

K061008510(k) TraditionalCleared Sep 8, 2006149-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

Quidel Corp. · MCE Respiratory Syncytial Virus - Elisa

Cleared on Sep 8, 2006 as substantially equivalent to K032166 (Binax, Inc., 2003) after a 149-day review. Its family tree reaches back 3 generations to 1988. 6 later devices descend from it.

Decided
Sep 8, 2006
Review
149 days
Class
Class I
Product code
MCE
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K882629 (1988). 6 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2010: 1 descendant cleared2013: 2 descendants cleared2012: 1 descendant cleared2017: 1 descendant clearedK882629 · Directigen Respiratory Syncytial Virus Test Kit · Bd Becton Dickinson Vacutainer Systems Preanalytic · 1988K022133 · BD Directigen EZ RSV Kit · Becton, Dickinson & CO · 2002 · recalledK032166 · Binax Now RSV Test, Model 430-000 and Binax Now Nasopharyngeal Swab Accessory Pack, Model 400-065 · Binax, Inc. · 2003 · recalled1990200020102020
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant K032166 · Binax Now RSV Test, Model 430-000 and Binax Now Nasopharyngeal Swab Accessory Pack, Model 400-065 · Binax, Inc. · 2003 · recalledK022133 · BD Directigen EZ RSV Kit · Becton, Dickinson & CO · 2002 · recalledK882629 · Directigen Respiratory Syncytial Virus Test Kit · Bd Becton Dickinson Vacutainer Systems Preanalytic · 19880
  1. Root · 3 generations backK882629 Directigen Respiratory Syncytial Virus Test KitBd Becton Dickinson Vacutainer Systems Preanalytic · 1988
  2. 2 generations backK022133 BD Directigen EZ RSV KitBecton, Dickinson & CO · 2002 · Recalled
  3. 1 generation backK032166 Binax Now RSV Test, Model 430-000 and Binax Now Nasopharyngeal Swab…Binax, Inc. · 2003 · Recalled
  4. This deviceK061008 Quickvue RSV (20 Test Kit), Model 20193; (2 Test Kit), Model 20199Quidel Corp. · 2006
  5. Descendant · cites it directly · 5 of its ownK070747 Quick Vue RSV Test, Models 20193, 20199Quidel Corp. · 2007
  6. Descendant · cites it directly · 4 of its ownK101918 Quickvue RSV 10Quidel Corp. · 2010
  7. Descendant · 2 generations on · 2 of its ownK121633 BD Veritor (TM) System for the Rapid Detection of RSVBecton, Dickinson and Company · 2012
  8. Descendant · 3 generations on · 1 of its ownK130398 Sofia (R) RSV FiaQuidel Corp. · 2013
  9. Descendant · 4 generations on · 0 of its ownK162911 Sofia RSV FIA on Sofia 2 analyzerQuidel Corporation · 2017 · Recalled

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2007: 12010: 12012: 12013: 22017: 1
2007high 2 (2013) · low 0 (2008)2026

Most influential descendants

Showing 5 of 6 · See all
  • K070747Quick Vue RSV Test, Models 20193, 20199Quidel Corp. · 2007 · cites it directly5descendants
  • K101918Quickvue RSV 10Quidel Corp. · 2010 · cites it directly4descendants
  • K121633BD Veritor (TM) System for the Rapid Detection of RSVBecton, Dickinson and Company · 2012 · 2 generations on2descendants
  • K130398Sofia (R) RSV FiaQuidel Corp. · 2013 · 3 generations on1descendant
  • K162911Sofia RSV FIA on Sofia 2 analyzerQuidel Corporation · 2017 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K882629Directigen Respiratory Syncytial Virus Test KitBd Becton Dickinson Vacutainer Systems Preanalytic1988—
−2K022133BD Directigen EZ RSV KitBecton, Dickinson & CO20021
−1K032166Binax Now RSV Test, Model 430-000 and Binax Now Nasopharyngeal Swab Accessory…Binax, Inc.20032
0 (this device)K061008Quickvue RSV (20 Test Kit), Model 20193; (2 Test Kit), Model 20199Quidel Corp.2006—
+1K070747Quick Vue RSV Test, Models 20193, 20199Quidel Corp.2007—
+1K101918Quickvue RSV 10Quidel Corp.2010—
+2K121633BD Veritor (TM) System for the Rapid Detection of RSVBecton, Dickinson and Company2012—
+3K130398Sofia (R) RSV FiaQuidel Corp.2013—
+4K162911Sofia RSV FIA on Sofia 2 analyzerQuidel Corporation20171

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201010
201210
201320
201710
FIG. 1 — Lineage of K061008, 1988–2017Source: 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.

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  • Recall history across each candidate’s familyin the report
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What was it cleared against? (1)

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
*K032166Binax Now RSV Test, Model 430-000 and Binax Now Nasopharyngeal Swab Accessory Pack…
Summary page 1
…e Trade Name: QuickVue® RSV test Common Name: Respiratory syncytial Virus (RSV) Test Predicate Device: Binax NOW© RSV Test (K032166) Device Classification/Name: 21 CFR 866.3480 I Respiratory syncytial virus serological reagent…
Binax, Inc.20032

Also cleared against K032166: 1 other device →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K070747Quick Vue RSV Test, Models 20193, 20199Quidel Corp.20075
K101918Quickvue RSV 10Quidel Corp.20104

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 18 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
  • 2 of the 3 ancestors have a recall of any class.
  • Of its descendants, K070747 (Quidel Corp., 2007) has gone furthest, with 5 descendants of its own.
  • 1 other device also cites its predicate K032166.

How does its category compare?

All MCE devices

MCE Respiratory Syncytial Virus - Elisa: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MCE

FDA has decided no MCE device since 2007.

Median 510(k) review, days · MCE

Too few MCE 510(k)s in any year since 2007 to give a median.

Recalls per year · MCE

No recall names MCE since 2007.

Adverse event reports per year · MCE

No MAUDE report names MCE since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The QuickVue® RSV test allows for the rapid, qualitative detection of respiratory syncytial virus (RSV) directly from nasopharyngeal swab, nasopharyngeal aspirate and/or nasal wash specimens for symptomatic patients eighteen years of age and younger. The test is intended for use as an aid in the rapid diagnosis of acute respiratory syncytial viral infections. 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 K032166

1 other device cites the same predicate.

  • K041445Immunocard Stat! RSV Model #750630Meridian Bioscience, Inc. · 2004

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 MCE

The MCE category page

  • K924289Kallestad RSV Microplate EiaBio-Rad Laboratories, Inc. · 1993

https://510kreport.com/device/K061008 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061008: Quickvue RSV (20 Test Kit), Model 20193; (2 Test Kit), Model 20199.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061008

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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