# K253971: Visby Medical Flu and COVID-19 Test

- Pathway: 510(k) (Traditional)
- Applicant: Visby Medical, Inc.
- Decided: May 27, 2026 after 167 days
- Product code: SIA (Over-The-Counter Molecular Multi-Analyte Respiratory Virus Detection Test)
- Device class: 2
- Regulation: 21 CFR 866.3984
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN220028 (2023). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN220028: Cue COVID-19 Molecular Test, Cue Health, Inc. (2023) Summary page 5.

## Indications for use
The Visby Medical Flu and COVID-19 Test is a single-use (disposable), fully integrated, automated RT PCR in vitro diagnostic test intended for the qualitative detection and differentiation of influenza A, influenza B, and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral RNA in anterior nasal swab samples from individuals with signs and symptoms of a viral respiratory infection. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar. This test is intended for 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 a lab-based 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 with their healthcare provider. Positive results do not rule out co-infection with other respiratory pathogens. This test is not a substitute for visits to a healthcare provider or appropriate follow-up and should not be used to determine any treatments without provider supervision.

Source page: https://510kreport.com/device/K253971
Methodology: https://510kreport.com/methodology