510(k) · Cleared
Recalled · 2007Binax Now RSV Test, Model 430-000 and Binax Now Nasopharyngeal Swab Accessory Pack, Model 400-065
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Binax, Inc. · GQG Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
Cleared on Oct 21, 2003 as substantially equivalent to K022133 (Becton, Dickinson & CO, 2002) and 1 other predicate after a 97-day review. Its family tree reaches back 2 generations to 1988. 9 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 21, 2003
- Review
- 97 days
- Class
- Class I
- Product code
- GQG
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to K882629 (1988). 9 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK882629 Directigen Respiratory Syncytial Virus Test KitBd Becton Dickinson Vacutainer Systems Preanalytic · 1988
- 1 generation backK022133 BD Directigen EZ RSV KitBecton, Dickinson & CO · 2002 · Recalled
- This deviceK032166 Binax Now RSV Test, Model 430-000 and Binax Now Nasopharyngeal Swab…Binax, Inc. · 2003
- Descendant · cites it directly · 6 of its ownK061008 Quickvue RSV (20 Test Kit), Model 20193; (2 Test Kit), Model 20199Quidel Corp. · 2006
- Descendant · 2 generations on · 5 of its ownK070747 Quick Vue RSV Test, Models 20193, 20199Quidel Corp. · 2007
- Descendant · 2 generations on · 4 of its ownK101918 Quickvue RSV 10Quidel Corp. · 2010
- Descendant · 3 generations on · 2 of its ownK121633 BD Veritor (TM) System for the Rapid Detection of RSVBecton, Dickinson and Company · 2012
- Descendant · 4 generations on · 1 of its ownK130398 Sofia (R) RSV FiaQuidel Corp. · 2013
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K061008Quickvue RSV (20 Test Kit), Model 20193; (2 Test Kit), Model 20199Quidel Corp. · 2006 · cites it directly6descendants
- K070747Quick Vue RSV Test, Models 20193, 20199Quidel Corp. · 2007 · 2 generations on5descendants
- K101918Quickvue RSV 10Quidel Corp. · 2010 · 2 generations on4descendants
- K121633BD Veritor (TM) System for the Rapid Detection of RSVBecton, Dickinson and Company · 2012 · 3 generations on2descendants
- K130398Sofia (R) RSV FiaQuidel Corp. · 2013 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 |
| 0 (this device) | K032166 | Binax Now RSV Test, Model 430-000 and Binax Now Nasopharyngeal Swab Accessory… | Binax, Inc. | 2003 | — |
| +1 | K061008 | Quickvue RSV (20 Test Kit), Model 20193; (2 Test Kit), Model 20199 | Quidel Corp. | 2006 | — |
| +2 | K070747 | Quick Vue RSV Test, Models 20193, 20199 | Quidel Corp. | 2007 | — |
| +2 | K101918 | Quickvue RSV 10 | Quidel Corp. | 2010 | — |
| +3 | K121633 | BD Veritor (TM) System for the Rapid Detection of RSV | Becton, Dickinson and Company | 2012 | — |
| +4 | K130398 | Sofia (R) RSV Fia | Quidel Corp. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2017 | 1 | 0 |
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 K253318 Clungene RSV Antigen Rapid Testscore 10.8 · 1 generation · no Class I recall
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K022133 | BD Directigen EZ RSV KitSummary page 2…he following summary. New data preseated irr the PerformanceSection d rhis applicarion, and rmmmarited below, establishes SE a f the N O W RSV test to the BD E2 RSV Kat (K022133) when cesdngnasopharyngeal swab specimens. And’c R e i a - d t y(wreprkdiu or@ud510@)K02I68g: There are two known subgroups… | 2002 |
| * | K882629 | Directigen Respiratory Syncytial Virus Test KitSummary page 2…ed membrane to capture and visualize anrigen. PERFORMANCE SUMMARY: The Binax NOW@RSV Test has already been detennind to be subscantidy equivdac (SE) ro rhe BD RSV Test (K882629)Fur &e detection d RSV in nasal wash specimens. Data supponing this SE Qtermhdon was preseocd in &e original SlO(k) KO21667 and i… | 1988 |
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 28, 2007 | Not classified | Z-0824-2007 | Other | Tip of the foam swab could detach from the shaft causing injury to the patient. |
| Feb 18, 2004 | Not classified | Z-0778-04 | Other | Pouch integrity compromised |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 14.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K061008 (Quidel Corp., 2006) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K022133.
How does its category compare?
All GQG devicesGQG 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
2026 to Oct 25, outlined.
Median 510(k) review, days · GQG
93in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GQG
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GQG
2in 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 | — |
What is it indicated for?
The Binax NOW® RSV Test is a rapid immunochromatographic assay for the qualitative detection of respiratory syncytial virus (RSV) fusion protein antigen in nasal wash and nasopharyngeal swab specimens from symptomatic patients. 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 five. It is recommended that negative test results be confirmed by culture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032166 · printed Nov 3, 2026
Cite this page
510(k) Report. “K032166: Binax Now RSV Test, Model 430-000 and Binax Now Nasopharyngeal Swab Accessory Pack, Model 400-065.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K032166
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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