Gold Standard Diagnostics, LLC · Class II · Cleared Oct 10, 2025
| K-number | K250249 |
| Device name | Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System |
| Applicant | Gold Standard Diagnostics, LLC |
| Product code | GMQ |
| Device class | Class II |
| Decision date | Oct 10, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 866.3820 |
The Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System is a nontreponemal flocculation test that qualitatively detects reagin antibodies in human serum to aid in syphilis diagnosis. It uses automated sample processing and image analysis on the AIX1000 Analyzer and can also determine titer levels in serially diluted samples. The test is not intended for blood or tissue donor screening.
The device uses a modified VDRL carbon antigen formulation (0.03% cardiolipin, 0.9% cholesterol, 0.21% lecithin) matching CDC standards. Key differences from predicate K150358 include use of a proprietary GSD RPR Diluent for high and extra-high titer samples (versus PBS only in predicate), and automated interpretation with titer reporting capability. The AIX1000 Analyzer delivers serum, adds antigen suspension, incubates with shaking, and captures high-resolution images analyzed by proprietary software algorithms.
Not stated in this summary.
View the full FDA submission: accessdata.fda.gov