K250249 is an FDA 510(k) clearance for the Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System. This device is classified as a Antigens, Nontreponemal, All (Class II - Special Controls, product code GMQ).
Submitted by Gold Standard Diagnostics, LLC (Davis, US). The FDA issued a Cleared decision on October 10, 2025, 256 days after receiving the submission on January 27, 2025.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3820.
| 510(k) Number | K250249 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 27, 2025 |
| Decision Date | October 10, 2025 |
| Days to Decision | 256 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | GMQ - Antigens, Nontreponemal, All |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3820 |