510(k) · Cleared
ClearedGenaCheck COVID-19 Rapid Self-Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genabio Diagnostics, Inc. · QYT Over-The-Counter Covid-19 Antigen Test
Cleared on Sep 5, 2025 as substantially equivalent to K233373 (ACON Laboratories, Inc., 2024) after an 88-day review. Its family tree reaches back 1 generation to 2024.
- Decided
- Sep 5, 2025
- Review
- 88 days
- Class
- Class II
- Product code
- QYT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K233373 (2024). No later device cites it as a predicate yet.
- Root · 1 generation backK233373 Flowflex® Plus COVID-19 Home TestACON Laboratories, Inc. · 2024
- This deviceK251753 GenaCheck COVID-19 Rapid Self-TestGenabio Diagnostics, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K233373 | Flowflex® Plus COVID-19 Home Test | ACON Laboratories, Inc. | 2024 | — |
| 0 (this device) | K251753 | GenaCheck COVID-19 Rapid Self-Test | Genabio Diagnostics, Inc. | 2025 | — |
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 QYT? 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 QYT device
- #1 K241313 OHC COVID-19 Antigen Self Testscore 12.4 · 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 |
|---|---|---|---|
| * | K233373 | Flowflex® Plus COVID-19 Home TestSummary page 5…tigen Test Classification: Class II Review panel: Microbiology Predicate device ACON - Flowflex Plus COVID-19 Home Test (K233373) 3. Device Description The GenaCheck® COVID-19 Rapid Self-Test is a rapid, qualitative latex particles based immuno- chromatogr… | 2024 |
| † | K213804 | cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems | 2022 |
| † | K231306 | cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems | 2023 |
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 QYT devicesQYT Over-The-Counter Covid-19 Antigen Test: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QYT
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QYT
138in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QYT
No recall names QYT since 2007.
Adverse event reports per year · QYT
82in 2025
MAUDE reports naming product code QYT, 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 | 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 | 1 | — | 0 | 0 |
| 2024 | 5 | 179 | 0 | 23 |
| 2025 | 5 | 138 | 0 | 82 |
| 2026 | 3 | 90 | 0 | — |
What is it indicated for?
The GenaCheck COVID-19 Rapid Self-Test is a visually read lateral flow immunoassay test intended for the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen directly in anterior nasal swab specimens from individuals with signs and symptoms of COVID-19. This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older. All negative results are…
Read the full statement (238 words)
The GenaCheck COVID-19 Rapid Self-Test is a visually read lateral flow immunoassay test intended for the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen directly in anterior nasal swab specimens from individuals with signs and symptoms of COVID-19.
This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older.
All negative results are presumptive. Symptomatic individuals with an initial negative test result must be re-tested once between 48 and 72 hours after the first test using either an antigen test or a molecular test for SARS-CoV-2. Negative results do not preclude SARS-CoV-2 infections or other pathogens and should not be used as the sole basis for treatment.
Positive results do not rule out co-infection with other respiratory pathogens.
This test is not a substitute for visits to a healthcare provider or appropriate follow-up and should not be used to determine any treatments without provider supervision. Individuals who test negative and experience continued or worsening COVID-19 like symptoms, such as fever, cough and/or shortness of breath, should seek follow up care from their healthcare provider.
The performance characteristics for SARS-CoV-2 were established from March 2024 to October 2024 when SARS-CoV-2 Omicron was dominant. Test accuracy may change as new SARS-CoV-2 viruses emerge. Additional testing with a lab-based molecular test (e.g., PCR) should be considered in situations where a new virus or variant is suspect.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K251753 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251753: GenaCheck COVID-19 Rapid Self-Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251753
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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