Identifiers
- 510(k) Number
- K160517 FDA 510(k)
- FDA Product Code
- OOI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.2570 FDA 510(k)
- Regulation Number
- 862.2570 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Aries System is a Real-Time Nucleic Acid Amplification System, designed for molecular diagnostics in clinical chemistry. It automates nucleic acid extraction, real-time PCR amplification, and signal detection for multiplex assays, enabling simultaneous analysis of multiple targets from various sample types.
This system is intended for use in clinical laboratory settings and is supplied as a reusable device. It operates under sterile conditions for nucleic acid processing and detection, with no specific MRI safety restrictions noted. The system supports multiple assay configurations, as indicated by its regulatory registration numbers, and holds FDA 510(k) clearance under Special Review (K160517). Sterility and maintenance protocols are manufacturer-defined, with no explicit single-use designation.
Frequently asked questions
What types of samples can the Aries System analyze, and how does it process them?
The Aries System automates nucleic acid extraction, real-time PCR amplification, and signal detection for multiplex assays, enabling simultaneous analysis of multiple targets from various sample types. It is designed for clinical laboratory settings and operates under sterile conditions for nucleic acid processing, ensuring reliable results for molecular diagnostics in clinical chemistry.
Is the Aries System intended for single-use or reusable applications, and what does that mean for maintenance?
The Aries System is supplied as a reusable device, meaning it is designed for repeated use in clinical settings. Sterility and maintenance protocols are manufacturer-defined, so proper cleaning, calibration, and upkeep are required to ensure consistent performance and compliance with sterile processing standards for nucleic acid handling.
What regulatory pathway was followed for the Aries System’s FDA clearance, and what does that imply for its use?
The Aries System received FDA 510(k) clearance under Special Review (K160517), classified as substantially equivalent to a predicate device in clinical chemistry. This implies the system meets FDA standards for safety and effectiveness as determined by the Medical Imaging and Intervention (MI) Review Panel, though it does not specify clinical indications—only that it adheres to regulatory requirements for molecular diagnostics in laboratories.
How many assay configurations does the Aries System support, and what does that mean for flexibility in testing?
The Aries System supports multiple assay configurations, as evidenced by its extensive list of FDA registration numbers (over 80 listed). This indicates broad compatibility with various multiplex assays, allowing laboratories to test for multiple targets simultaneously across different sample types, enhancing diagnostic flexibility without requiring additional hardware.
Are there any special handling requirements for the Aries System, such as storage or environmental conditions?
While the device data does not specify exact storage conditions, the Aries System is designed for clinical laboratory use with sterile processing for nucleic acid handling. Proper storage should follow manufacturer guidelines to maintain performance, though no explicit restrictions (like temperature or humidity) are mentioned beyond standard laboratory practices for reusable diagnostic equipment.
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: PDF ARIES® Systems Quick Guide - Biorus, PDF ARIES® System, LUMINEX CORPORATION ARIES M12V1 ARIES® System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K160517 | Class II | Active |
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Manufacturer
- Manufacturer
- Luminex Corporation
Sources (1)
- FDA 510(k) K160517 24 fields · synced Oct 6, 2026