Clearance Summary
IDS-iSYS Total Testosterone received FDA 510(k) clearance under submission number K252728, sponsored by Immunodiagnostic Systems Limited. 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 2026-04-15.
- Submission: K252728
- Applicant / Sponsor: Immunodiagnostic Systems Limited
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1680
- Decision date: 2026-04-15
Classification & Regulation
This clearance is catalogued under FDA product code CDZ and 21 CFR 862.1680, within the Clinical Chemistry review panel as a Class I device.