510(k) · Cleared
ClearedClungene RSV Antigen Rapid Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hangzhou Clongene Biotech Co., Ltd. · GQG Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
Cleared on Jan 30, 2026 as substantially equivalent to K240280 (Nano-Ditech Corporation, 2024) after a 122-day review. Its family tree reaches back 1 generation to 2024.
- Decided
- Jan 30, 2026
- Review
- 122 days
- Class
- Class I
- Product code
- GQG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K240280 (2024). No later device cites it as a predicate yet.
- Root · 1 generation backK240280 Nano-Check™ RSV TestNano-Ditech Corporation · 2024
- This deviceK253318 Clungene RSV Antigen Rapid TestHangzhou Clongene Biotech Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K240280 | Nano-Check™ RSV Test | Nano-Ditech Corporation | 2024 | — |
| 0 (this device) | K253318 | Clungene RSV Antigen Rapid Test | Hangzhou Clongene Biotech Co., Ltd. | 2026 | — |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K240280 | Nano-Check™ RSV TestSummary page 5…Microbiology Respiratory Syncytial Virus Serological Reagents 6. Predicate Devices: K240280, Nano-Check RSV Test 7. Intended Use The Clungene RSV Antigen Rapid Test is a lateral flow immunoassay intended for the qu… | 2024 |
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?
- Its one ancestor has no recall.
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. 2026, 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 Clungene RSV Antigen Rapid Test is a lateral flow immunoassay intended for the qualitative detection of respiratory syncytial virus (RSV) nucleoprotein antigen in nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection. The test is intended for in vitro diagnostic use as an aid in the diagnosis of RSV infections. Negative results do not preclude RSV infection and should not be used as the sole basis for treatment or patient management decisions. A negative test is presumptive. It is recommended that negative test results be confirmed by viral cell culture or an FDA-cleared molecular assay.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253318 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253318: Clungene RSV Antigen Rapid Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253318
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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