510(k) · Cleared
ClearedHealgen Rapid COVID-19 Antigen Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Healgen Scientific,, LLC · QVF Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
Cleared on Apr 19, 2024 as substantially equivalent to DEN220039 (Quidel Corporation, 2023) after a 255-day review. Its family tree reaches back 1 generation to 2023.
- Decided
- Apr 19, 2024
- Review
- 255 days
- Class
- Class II
- Product code
- QVF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN220039 (2023). No later device cites it as a predicate yet.
- Root · 1 generation backDEN220039 Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab SetQuidel Corporation · 2023
- This deviceK232377 Healgen Rapid COVID-19 Antigen TestHealgen Scientific,, LLC · 2024
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) | K232377 | Healgen Rapid COVID-19 Antigen Test | Healgen Scientific,, LLC | 2024 | — |
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 K231187 Nano-Check™ COVID-19 Antigen Testscore 18.7 · 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 10…ate Device: Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set (DEN220039; granted March 8, 2023) F. Intended Use: 1. Intended use(s): The Healgen R… | 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.
- 4 other devices also cite its predicate DEN220039.
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 Healgen Rapid COVID-19 Antigen Test is a lateral flow immunochromatographic assay intended for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal swabs from individuals with signs and symptoms of upper respiratory infection within the first six (6) 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…
Read the full statement (195 words)
The Healgen Rapid COVID-19 Antigen Test is a lateral flow immunochromatographic assay intended for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal swabs from individuals with signs and symptoms of upper respiratory infection within the first six (6) 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 tested at least twice over three days with at least 48 hours between tests; or when tested once, and negative by the Healgen Rapid COVID-19 Antigen Test, and followed with a molecular test.
The test does not differentiate between SARS-CoV and SARS-CoV-2.
A negative test result is presumptive, and it is recommended these results be confirmed by a molecular SARS-CoV-2 assay. Negative results do not preclude SARS-CoV-2 infections and should not be used as the sole basis for treatment or other patient management decisions.
Positive results do not rule out co-infection with other respiratory pathogens.
Performance characteristics for SARS-CoV-2 were established from May 2022 to July 2022 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/K232377 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232377: Healgen Rapid 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/K232377
Report an extraction error
Are you the manufacturer?
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