# DEN240029: Healgen Rapid Check COVID-19/Flu A&B Antigen Test

- Pathway: De Novo (Direct)
- Applicant: Healgen
- Decided: Oct 7, 2024 after 122 days
- Product code: SCA (Multi-Analyte Respiratory Virus Antigen Detection Test)
- Device class: 2
- Regulation: 21 CFR 866.3987
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 4 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K243256: WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest (2025), 4 descendants of its own
- K251085: iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro (2025), 0 descendants of its own
- K251092: iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro (2025), 0 descendants of its own
- K251538: Status™ COVID-19/Flu A&B (2025), 0 descendants of its own
- K251604: CareSuperb COVID-19/Flu A&B Antigen Combo Home Test (2025), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/DEN240029
Methodology: https://510kreport.com/methodology