# K251085: iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro

- Pathway: 510(k) (Traditional)
- Applicant: Ihealth Labs, Inc.
- Decided: Dec 12, 2025 after 247 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 6.

## Indications for use
The iHealth Flu A&B/COVID-19/RSV Rapid Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, influenza B, SARS-CoV-2, and respiratory syncytial virus (RSV) protein antigens directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. Symptoms of respiratory infections due to influenza, SARS-CoV-2, and RSV 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 six (6) months 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, RSV, or other pathogens. Individuals who test negative and/or experience continued or worsening 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 iHealth Flu A&B/COVID-19/RSV Rapid Test Pro is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, influenza B, SARS-CoV-2, and respiratory syncytial virus (RSV) protein antigens directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. Symptoms of respiratory infections due to influenza, SARS-CoV-2, and RSV can be similar. This test is for use by individuals aged 14 years or older testing themselves, or adults testing individuals aged six (6) months 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, RSV, or other pathogens. Individuals who test negative and/or 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. Test results should not be used as the sole basis for treatment or other patient management decisions.

Source page: https://510kreport.com/device/K251085
Methodology: https://510kreport.com/methodology