ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K161495 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 MI System is a real-time nucleic acid amplification system designed for in vitro diagnostic (IVD) use. It automates nucleic acid extraction, purification, and fluorescence-based PCR amplification for detecting target sequences in clinical samples, including those for herpes simplex virus (HSV) types 1 and 2.
This system is intended for laboratory use and includes single-use assay cassettes (supplied in cartons of 24) and a protocol file kit. The ARIES HSV 1&2 Assay Cassettes are sterile, single-use components for automated sample processing, while the system itself is classified as Class II (Special) under FDA regulations (510(k) clearance K161495). Storage and handling follow standard IVD protocols for nucleic acid testing.
Frequently asked questions
What is the ARIES MI System primarily used for in a clinical laboratory setting?
The ARIES MI System is designed for in vitro diagnostic (IVD) use to automate nucleic acid extraction, purification, and fluorescence-based PCR amplification. It specifically detects target sequences in clinical samples, including those for herpes simplex virus (HSV) types 1 and 2, making it useful for molecular diagnostics in laboratory settings.
Are the ARIES HSV 1&2 Assay Cassettes meant for single-use or repeated use?
The ARIES HSV 1&2 Assay Cassettes are explicitly labeled as single-use components. They are sterile and intended for automated sample processing in the ARIES MI System, ensuring each cassette is used only once to maintain accuracy and prevent cross-contamination.
How are the ARIES HSV 1&2 Assay Cassettes supplied, and what does a carton of 24 include?
The ARIES HSV 1&2 Assay Cassettes are supplied in cartons containing 24 individual, single-use cassettes. Each cassette is sterile and designed for automated processing within the ARIES MI System, ensuring consistency and reliability for HSV 1 and 2 detection.
What regulatory pathway was followed for the ARIES MI System’s FDA clearance?
The ARIES MI System was cleared through the FDA’s 510(k) pathway, specifically under the classification of Class II (Special) devices. The submission was reviewed by the Clinical Chemistry (CH) advisory committee, and the decision was based on a determination of substantial equivalence (SESE) to a predicate device, as indicated by the clearance number K161495.
How should the ARIES MI System and its components be stored according to standard IVD protocols?
While the exact storage conditions are not detailed in the provided data, the ARIES MI System and its components, including the ARIES HSV 1&2 Assay Cassettes, follow standard IVD protocols for nucleic acid testing. This typically includes maintaining appropriate temperature, humidity, and protection from light to preserve sterility and functionality, as implied by the system’s classification as an IVD device.
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: ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD ..., ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay ..., Aries Mi System, Aries Hsv 1&2 Assay Cassettes-carton Of 24 (ivd ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161495 | Class II | Active |
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Manufacturer
- Manufacturer
- Luminex Corporation
Sources (1)
- FDA 510(k) K161495 24 fields · synced Oct 6, 2026