510(k) · Cleared
ClearedWELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wondfo USA Co, Ltd. · SCA Multi-Analyte Respiratory Virus Antigen Detection Test
Cleared on Jan 16, 2025 as substantially equivalent to DEN240029 (Healgen, 2024) after a 93-day review. Its family tree reaches back 1 generation to 2024. 4 later devices descend from it.
- Decided
- Jan 16, 2025
- Review
- 93 days
- Class
- Class II
- Product code
- SCA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN240029 (2024). 4 later devices descend from it, 4 citing it directly.
- Root · 1 generation backDEN240029 Healgen Rapid Check COVID-19/Flu A&B Antigen TestHealgen · 2024
- This deviceK243256 WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 /…Wondfo USA Co, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK251085 iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu…Ihealth Labs, Inc. · 2025
- Descendant · cites it directly · 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 ownK251604 CareSuperb COVID-19/Flu A&B Antigen Combo Home TestAccess Bio, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK251563 WELLlife Flu A&B Home Test; WELLlife Influenza A&B TestWondfo USA Co, Ltd. · 2025
Most influential descendants
Showing 4 of 4 · See all- K251085iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test ProIhealth Labs, Inc. · 2025 · cites it directly0descendants
- K251092iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test ProIhealth Labs, Inc. · 2025 · cites it directly0descendants
- K251604CareSuperb COVID-19/Flu A&B Antigen Combo Home TestAccess Bio, Inc. · 2025 · cites it directly0descendants
- K251563WELLlife Flu A&B Home Test; WELLlife Influenza A&B TestWondfo USA Co, Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN240029 | Healgen Rapid Check COVID-19/Flu A&B Antigen Test | Healgen | 2024 | — |
| 0 (this device) | K243256 | WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza… | Wondfo USA Co, Ltd. | 2025 | — |
| +1 | K251085 | iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid… | Ihealth Labs, Inc. | 2025 | — |
| +1 | K251092 | iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro | Ihealth Labs, Inc. | 2025 | — |
| +1 | K251604 | CareSuperb COVID-19/Flu A&B Antigen Combo Home Test | Access Bio, Inc. | 2025 | — |
| +1 | K251563 | WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test | Wondfo USA Co, Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 4 | 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 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 K251085 iHealth Flu A&B/COVID-19/RSV Rapid Test…score 10.8 · 2 generations · 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 |
|---|---|---|---|
| * | DEN240029 | Healgen Rapid Check COVID-19/Flu A&B Antigen TestSummary page 6…Review Panel Microbiology Legally Marketed Predicate Device Trade Name Healgen Rapid Check COVID-19/flu A&B Antigen Test 510(k) Number DEN240029 Product Code SCA Review Panel Microbiology Page 1… | 2024 |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251085 | iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro | 2025 | 0 |
| K251092 | iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro | 2025 | 0 |
| K251604 | CareSuperb COVID-19/Flu A&B Antigen Combo Home Test | 2025 | 0 |
| K251563 | WELLlife Flu A&B Home Test; WELLlife Influenza A&B 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?
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. 2025, 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 WELLlife™ COVID-19 / Influenza A&B Home 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…
Read the full statement (349 words)
The WELLlife™ COVID-19 / Influenza A&B Home 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.
The WELLlife™ COVID-19 / Influenza 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 use by individuals aged 14 years or older testing themselves, or adults testing 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 providers.
Positive results do not rule out co-infection with other respiratory pathogens.
Test results should not be used as the sole basis for treatment or other patient management decisions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243256 · printed Nov 3, 2026
Cite this page
510(k) Report. “K243256: WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K243256
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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