Clearance Summary
FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette received FDA 510(k) clearance under submission number K250117, sponsored by Assure Tech., LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2025-02-13.
- Submission: K250117
- Applicant / Sponsor: Assure Tech., LLC
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1155
- Decision date: 2025-02-13
Classification & Regulation
This clearance is catalogued under FDA product code LCX and 21 CFR 862.1155, within the Clinical Chemistry review panel as a Class II device.