# K251604: CareSuperb COVID-19/Flu A&B Antigen Combo Home Test

- Pathway: 510(k) (Traditional)
- Applicant: Access Bio, Inc.
- Decided: Aug 22, 2025 after 87 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
Longest line of descent: 2 generations back to DEN240029 (2024). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243256: WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest, Wondfo USA Co, Ltd. (2025) Summary page 5.

## Indications for use
The CareSuperb COVID-19/Flu A&B Antigen Combo 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 antigens 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 for appropriate follow-up.

Source page: https://510kreport.com/device/K251604
Methodology: https://510kreport.com/methodology