De Novo · Granted
GrantedHealgen Rapid Check COVID-19/Flu A&B Antigen Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Healgen · SCA Multi-Analyte Respiratory Virus Antigen Detection Test
Granted on Oct 7, 2024 as a new device type through De Novo after a 122-day review. 8 later devices descend from it.
- Decided
- Oct 7, 2024
- Review
- 122 days
- Class
- Class II
- Product code
- SCA
- Recalls
- None
8 later devices descend from it, 4 citing it directly.
- This deviceDEN240029 Healgen Rapid Check COVID-19/Flu A&B Antigen TestHealgen · 2024
- Descendant · cites it directly · 4 of its ownK243256 WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 /…Wondfo USA Co, Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK251085 iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu…Ihealth Labs, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK251092 iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid…Ihealth Labs, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK251538 Status™ COVID-19/Flu A&BPrinceton BioMeditech Corp. · 2025
- Descendant · 2 generations on · 0 of its ownK251604 CareSuperb COVID-19/Flu A&B Antigen Combo Home TestAccess Bio, Inc. · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K243256WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B…Wondfo USA Co, Ltd. · 2025 · cites it directly4descendants
- K251085iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test ProIhealth Labs, Inc. · 2025 · 2 generations on0descendants
- K251092iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test ProIhealth Labs, Inc. · 2025 · 2 generations on0descendants
- K251538Status™ COVID-19/Flu A&BPrinceton BioMeditech Corp. · 2025 · cites it directly0descendants
- K251604CareSuperb COVID-19/Flu A&B Antigen Combo Home TestAccess Bio, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN240029 | Healgen Rapid Check COVID-19/Flu A&B Antigen Test | Healgen | 2024 | — |
| +1 | K243256 | WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza… | Wondfo USA Co, Ltd. | 2025 | — |
| +2 | K251085 | iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid… | Ihealth Labs, Inc. | 2025 | — |
| +2 | K251092 | iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro | Ihealth Labs, Inc. | 2025 | — |
| +1 | K251538 | Status™ COVID-19/Flu A&B | Princeton BioMeditech Corp. | 2025 | — |
| +2 | K251604 | CareSuperb COVID-19/Flu A&B Antigen Combo Home Test | Access Bio, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 8 | 0 |
Sources: FDA De Novo 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 SCA? 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 SCA device
- #1 K243256 WELLlife™ COVID-19 / Influenza A&B Home Test…score 20.7 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (8)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243256 | WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B… | 2025 | 4 |
| K251538 | Status™ COVID-19/Flu A&B | 2025 | 0 |
| K243561 | Nano-Check Influenza+COVID-19 Dual Test | 2025 | 0 |
| K243262 | QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test | 2025 | 0 |
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?
- Of its descendants, K243256 (Wondfo USA Co, Ltd., 2025) has gone furthest, with 4 descendants of its own.
How does its category compare?
All SCA devicesSCA Multi-Analyte Respiratory Virus Antigen Detection Test: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · SCA
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SCA
116in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · SCA
No recall names SCA since 2007.
Adverse event reports per year · SCA
4in 2025
MAUDE reports naming product code SCA, 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 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 10 | 116 | 0 | 4 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Healgen Rapid Check COVID-19/Flu A&B Antigen Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. Symptoms of respiratory infections due to SARS-CoV-2 and influenza can be similar. This test is…
Read the full statement (175 words)
The Healgen Rapid Check COVID-19/Flu A&B Antigen Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. Symptoms of respiratory infections due to SARS-CoV-2 and influenza can be similar. 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 and should be confirmed with an FDA-cleared molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out infection with influenza, SARS-CoV-2 or other pathogens. Individuals who test negative and experience continued or worsening respiratory symptoms, such as fever, cough and/or shortness of breath, should seek follow-up care from their healthcare provider.
Positive results do not rule out co-infection with other respiratory pathogens, and therefore do not substitute for a visit to a healthcare provider or appropriate follow-up.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN240029 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN240029: Healgen Rapid Check COVID-19/Flu A&B Antigen Test.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN240029
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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