Clearance Summary
Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System received FDA 510(k) clearance under submission number K250249, sponsored by Gold Standard Diagnostics, 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 2025-10-10.
- Submission: K250249
- Applicant / Sponsor: Gold Standard Diagnostics, LLC
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3820
- Decision date: 2025-10-10
Classification & Regulation
This clearance is catalogued under FDA product code GMQ and 21 CFR 866.3820, within the Microbiology review panel as a Class II device.