AIX1000 Rapid Plasma Reagin (RPR) Automated Test System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K250249 FDA 510(k)
- FDA Product Code
- GMQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3820 FDA 510(k)
- Regulation Number
- 866.3820 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The AIX1000 is an automated system for nontreponemal, rapid plasma reagin (RPR) testing, classified as an antigen, nontreponemal diagnostic device. It performs automated aliquoting of RPR reagents and mechanical agitation to facilitate serological testing for syphilis screening and titer monitoring.
The system processes samples in up to four 48-well microtiter plates using a single dual-needle probe and orbital shaker. Supplied as a reusable instrument, it requires no sterilisation between uses and is designed for laboratory settings. Compliance is evidenced by FDA 510(k) clearance (K250249) and regulatory classification under 21 CFR 866.3820. Storage and operation follow manufacturer guidelines for automated immunoassay systems.
Frequently asked questions
What clinical purpose does the AIX1000 Rapid Plasma Reagin (RPR) Automated Test System serve in a lab setting?
The AIX1000 is designed specifically for automated nontreponemal serological testing, primarily used for syphilis screening and monitoring antibody titers. It automates the aliquoting of RPR reagents and mechanical agitation to streamline sample processing, improving efficiency for routine diagnostic workflows in microbiology labs.
Is the AIX1000 a single-use or reusable device, and what does that mean for maintenance?
The AIX1000 is a reusable instrument, meaning it is built for repeated use in laboratory settings without requiring sterilization between tests. This design reduces waste and operational costs, though routine maintenance and cleaning per manufacturer guidelines are necessary to ensure consistent performance and compliance with automated immunoassay best practices.
How many sample plates can the AIX1000 process at once, and what format do those plates use?
The system processes up to four 48-well microtiter plates simultaneously, utilizing a single dual-needle probe and orbital shaker to automate reagent handling and sample agitation. This setup allows for high-throughput testing while maintaining precision in serological analysis.
What regulatory pathway was followed for FDA clearance of the AIX1000, and what does that imply for its use?
The AIX1000 received FDA clearance through a traditional 510(k) pathway, classified as substantially equivalent under 21 CFR 866.3820 for antigen, nontreponemal diagnostic devices. This implies it meets established safety and performance standards for syphilis screening and titer monitoring in clinical microbiology labs, though users should always follow the manufacturer’s instructions for proper operation.
Are there specific storage requirements for the AIX1000 beyond standard automated immunoassay equipment?
While the AIX1000’s storage and operational guidelines align with typical automated immunoassay systems, it’s critical to follow the manufacturer’s instructions to ensure optimal performance. This likely includes environmental conditions (e.g., temperature, humidity) and protection from contamination, though no additional regulatory storage restrictions are explicitly noted beyond general lab equipment standards.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: AIX1000® RPR Analyzer, AIX1000® RPR Analyzer - clinical.goldstandarddiagnostics.com, PDF AIX_Brochure_RevC_final, Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250249 | Class II | Active |
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Manufacturer
- Manufacturer
- Gold Standard Diagnostics, LLC
Sources (1)
- FDA 510(k) K250249 24 fields · synced Oct 6, 2026