Clearance Summary
Simplexa COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460) received FDA 510(k) clearance under submission number K252387, sponsored by Diasorin Molecular, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2025-10-30.
- Submission: K252387
- Applicant / Sponsor: Diasorin Molecular, LLC
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3981
- Decision date: 2025-10-30
Classification & Regulation
This clearance is catalogued under FDA product code QOF and 21 CFR 866.3981, within the Microbiology review panel as a Class II device.