510(k) · Cleared
ClearedNano-Check™ COVID-19 Antigen Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nano-Ditech Corporation · QVF Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
Cleared on Jan 23, 2024 as substantially equivalent to DEN220039 (Quidel Corporation, 2023) after a 272-day review. Its family tree reaches back 1 generation to 2023. 4 later devices descend from it.
- Decided
- Jan 23, 2024
- Review
- 272 days
- Class
- Class II
- Product code
- QVF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN220039 (2023). 4 later devices descend from it, 4 citing it directly.
- Root · 1 generation backDEN220039 Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab SetQuidel Corporation · 2023
- This deviceK231187 Nano-Check™ COVID-19 Antigen TestNano-Ditech Corporation · 2024
- Descendant · cites it directly · 0 of its ownK253882 CorDx Tyfast COVID-19 Ag Rapid Test RxCorDx, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK251289 WELLlife COVID-19 Antigen Test RxGuangzhou Wondfo Biotech Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK243872 BD Veritor System for SARS-CoV-2Becton, Dickinson and Company · 2025
- Descendant · cites it directly · 0 of its ownK250273 BinaxNOW COVID-19 Ag CardAbbott Diagnostics Scarborough, Inc. · 2025
Most influential descendants
Showing 4 of 4 · See all- K253882CorDx Tyfast COVID-19 Ag Rapid Test RxCorDx, Inc. · 2026 · cites it directly0descendants
- K251289WELLlife COVID-19 Antigen Test RxGuangzhou Wondfo Biotech Co., Ltd. · 2025 · cites it directly0descendants
- K243872BD Veritor System for SARS-CoV-2Becton, Dickinson and Company · 2025 · cites it directly0descendants
- K250273BinaxNOW COVID-19 Ag CardAbbott Diagnostics Scarborough, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN220039 | Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set | Quidel Corporation | 2023 | — |
| 0 (this device) | K231187 | Nano-Check™ COVID-19 Antigen Test | Nano-Ditech Corporation | 2024 | — |
| +1 | K253882 | CorDx Tyfast COVID-19 Ag Rapid Test Rx | CorDx, Inc. | 2026 | — |
| +1 | K251289 | WELLlife COVID-19 Antigen Test Rx | Guangzhou Wondfo Biotech Co., Ltd. | 2025 | — |
| +1 | K243872 | BD Veritor System for SARS-CoV-2 | Becton, Dickinson and Company | 2025 | — |
| +1 | K250273 | BinaxNOW COVID-19 Ag Card | Abbott Diagnostics Scarborough, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 3 | 0 |
| 2026 | 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 QVF? 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 QVF device
- #1 K254264 Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIAscore 12.0 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | DEN220039 | Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab SetSummary page 4…st: Qualitative lateral flow immunoassay III. Predicate Device A. Trade Name: Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set B. De Novo Number: DEN220039 (granted March 8, 2023) Page | 1 C. Product Code: QVF This predicate has not been subject to a design-related… | 2023 |
What descends from it? (4)
4 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All QVF devicesQVF Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QVF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QVF
180in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QVF
No recall names QVF since 2007.
Adverse event reports per year · QVF
No MAUDE report names QVF since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 3 | 272 | 0 | 0 |
| 2025 | 3 | 180 | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Nano-Check COVID-19 Antigen Test is a lateral flow immunochromatographic assay for the rapid, qualitative detection of SARS-CoV-2 nucleoprotein protein antigens directly in anterior nasal swab specimens from individuals with signs and symptoms of upper respiratory infection (i.e., symptomatic) when testing is started within 4 days of symptom onset. The test is intended for use as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19) in…
Read the full statement (192 words)
The Nano-Check COVID-19 Antigen Test is a lateral flow immunochromatographic assay for the rapid, qualitative detection of SARS-CoV-2 nucleoprotein protein antigens directly in anterior nasal swab specimens from individuals with signs and symptoms of upper respiratory infection (i.e., symptomatic) when testing is started within 4 days of symptom onset. The test is intended for use as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19) in symptomatic individuals when either: tested at least twice over three days with at least 48 hours between tests; or when tested once, and negative by the Nano-Check™ COVID-19 Antigen Test and followed up with a molecular test.
The test does not differentiate between SARS-CoV or SARS-CoV-2.
A negative test result is presumptive, and it is recommended these results be confirmed by a molecular SARS-CoV-2 assay. Positive results do not rule out co-infection with other bacteria or viruses and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.
Performance characteristics for SARS-CoV-2 were established during the 2022-2023 SARSCoV-2 pandemic when SARS-CoV-2 Omicron was the predominant SARS-CoV-2 variant in circulation. When other SARS-CoV-2 virus variants are emerging, performance characteristics may vary.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231187 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231187: Nano-Check™ COVID-19 Antigen Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231187
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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