AIX1000 Rapid Plasma Reagin (RPR) Automated Test System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K150358 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 Rapid Plasma Reagin (RPR) Automated Test System is an automated diagnostic device designed for nontreponemal antigen testing. It performs rapid plasma reagin (RPR) assays to detect antibodies associated with syphilis infection, enabling screening and titer monitoring in clinical microbiology settings.
This system automates RPR testing by aliquoting reagents into up to four 48-well microtiter plates using a dual-needle probe and an orbital shaker for incubation. Supplied as a reusable instrument with consumable reagent packs, it requires storage of unopened components between 2–8°C and is intended for use in clinical microbiology laboratories. The device holds FDA 510(k) clearance and IVDD authorization.
Frequently asked questions
What clinical setting is the AIX1000 Rapid Plasma Reagin (RPR) Automated Test System designed for, and what does it test for?
The AIX1000 is designed for use in clinical microbiology laboratories and automates nontreponemal antigen testing specifically for rapid plasma reagin (RPR) assays. It detects antibodies associated with syphilis infection, making it useful for screening and titer monitoring of patients.
How is the AIX1000 system supplied, and what are its key components?
The AIX1000 is supplied as a reusable instrument paired with consumable reagent packs. It automates testing by aliquoting reagents into up to four 48-well microtiter plates using a dual-needle probe and an orbital shaker for incubation. The system itself is durable, while the reagents are disposable and must be stored unopened between 2–8°C.
Is the AIX1000 system single-use or reusable, and how should its components be stored?
The instrument itself is reusable, but it requires consumable reagent packs for each testing session. Unopened reagent components must be stored between 2–8°C to maintain integrity. The microtiter plates and other consumables are designed for single-use per assay.
What regulatory pathways has the AIX1000 followed, and what does that mean for its use?
The AIX1000 holds FDA 510(k) clearance (K150358) and In Vitro Diagnostic Device (IVDD) authorization, confirming it meets U.S. and EU regulatory standards for automated nontreponemal antigen testing. This means it can legally be used in FDA-regulated clinical microbiology labs and IVDD-compliant settings in Europe, ensuring compliance with both jurisdictions.
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 GSD-RPR-150727 Rev E - AIX1000 RPR Insert, Gold Standard Diagnostics AIX1000 RPR Analyzer - Cardinal Health, PDF GSD-RPR-150727 Rev E - AIX1000 RPR Insert
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K150358 | Class II | Active |
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Manufacturer
- Manufacturer
- Gold Standard Diagnostics
Sources (2)
- FDA 510(k) K150358 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026