510(k) · Cleared
ClearedBD Directigen EZ RSV
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson & CO · GQG Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
Cleared on Jul 9, 2010 as substantially equivalent to K022133 (Becton, Dickinson & CO, 2002) after a 37-day review. Its family tree reaches back 2 generations to 1988.
- Decided
- Jul 9, 2010
- Review
- 37 days
- Class
- Class I
- Product code
- GQG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K882629 (1988). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K022133 | BD Directigen EZ RSV KitSummary page 1…gical reagents DEVICE CLASSIFICATION: 21 CFR 866.3480 PREDICATE DEVICES: BID Directigen Tm EZ RSV assay (K022133) INTENDED USE: The DirectigenTm EZ RSV test is a rapid chromatographic immunoassay for the direct and qualitative detection of… | 2002 |
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 22 years and passes through 2 companies; a new generation was cleared every 14.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 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. 2010, this device’s year, is highlighted.
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 Directigen EZ RSV test is a rapid chromatographic immunoassay for the direct and qualitative detection of Respiratory Syncytial Virus (RSV) antigen in nasopharyngeal washes, nasopharyngeal aspirates, nasopharyngeal swabs and nasopharyngeal swab/washes from patients suspected of having a viral respiratory infection. This test is intended for in vitro diagnostic use to aid in the diagnosis of Respiratory Syncytial Virus (RSV) infections in neonatal and pediatric patients under the age of 20. It is recommended that negative test results be confirmed by cell culture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101514 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101514: BD Directigen EZ RSV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101514
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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