510(k) K260754
K260754 is an FDA 510(k) premarket notification submitted by Assure Tech., LLC for the device "Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test". The FDA issued a decision of Substantially Equivalent on June 5, 2026. The device falls under product code QYT (Over-The-Counter Covid-19 Antigen Test), a Class II device regulated under 21 CFR 866.3984. Assure Tech., LLC has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 5, 2026
- Date Received
- March 9, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Over-The-Counter Covid-19 Antigen Test
- Device Class
- Class II
- Regulation Number
- 866.3984
- Review Panel
- MI
- Submission Type
For the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen in individuals 2 years and older.