510(k) K253971
K253971 is an FDA 510(k) premarket notification submitted by Visby Medical, Inc. for the device "Visby Medical Flu and COVID-19 Test". The FDA issued a decision of Substantially Equivalent on May 27, 2026. The device falls under product code SIA (Over-The-Counter Molecular Multi-Analyte Respiratory Virus Detection Test), a Class II device regulated under 21 CFR 866.3984. Visby Medical, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 27, 2026
- Date Received
- December 11, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Over-The-Counter Molecular Multi-Analyte Respiratory Virus Detection Test
- Device Class
- Class II
- Regulation Number
- 866.3984
- Review Panel
- MI
- Submission Type
An over-the-counter molecular multi-analyte respiratory virus detection test is an in vitro diagnostic device for the detection and/or differentiation of respiratory viruses directly from clinical specimens. The device is intended to be used by lay users and without health care provider (HCP) intervention in home settings or similar environments.