Clearance Summary
Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test kit, Aptima Trichomonas Vaginalis (Panther) - 250 test kit, Aptima Trichomonas Vaginalis (Tigris) - 250 test kit received FDA 510(k) clearance under submission number K200436, sponsored by Hologic, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2020-03-23.
- Submission: K200436
- Applicant / Sponsor: Hologic, Inc.
- Clearance pathway: Special
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3393
- Decision date: 2020-03-23
Classification & Regulation
This clearance is catalogued under FDA product code QEP and 21 CFR 866.3393, within the Microbiology review panel as a Class II device.