ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protoco…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K151906 FDA 510(k)
- FDA Product Code
- PGI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3309 FDA 510(k)
- Regulation Number
- 866.3309 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ARIES HSV 1 & 2 Assay is a DNA detection assay for cutaneous and mucocutaneous lesion samples, designed for the qualitative detection and differentiation of herpes simplex virus type 1 (HSV-1) and type 2 (HSV-2) DNA. This in vitro diagnostic (IVD) test employs real-time polymerase chain reaction (PCR) technology to provide rapid and specific identification of HSV infection in clinical specimens.
The ARIES HSV 1 & 2 Assay is supplied as a combination of assay cassettes (each containing reagents for extraction, purification, and amplification) and a protocol file kit, intended for use on the ARIES M1 System—a fully automated nucleic acid testing platform. The cassettes are single-use, non-sterile, and require laboratory processing; compliance is governed under FDA 510(k) clearance (K151906) as a Class II device under regulation 866.3309. Storage and handling follow standard IVD laboratory protocols.
Frequently asked questions
What clinical samples is the ARIES HSV 1&2 Assay designed to test for herpes simplex virus detection?
The ARIES HSV 1&2 Assay is specifically designed for cutaneous and mucocutaneous lesion samples. It uses real-time PCR technology to detect and differentiate HSV-1 and HSV-2 DNA in these types of clinical specimens, enabling rapid and specific identification of the virus.
How is the ARIES HSV 1&2 Assay supplied, and is it intended for single-use?
The ARIES HSV 1&2 Assay is supplied as a combination of single-use, non-sterile assay cassettes (each containing reagents for extraction, purification, and amplification) and a protocol file kit. The cassettes are not sterile and require laboratory processing before use on the ARIES M1 System, a fully automated nucleic acid testing platform.
What storage and handling requirements apply to the ARIES HSV 1&2 Assay?
The ARIES HSV 1&2 Assay follows standard in vitro diagnostic (IVD) laboratory protocols for storage and handling. While specific storage conditions are not detailed, it is important to adhere to general IVD laboratory practices to maintain assay integrity, such as proper temperature control and protection from contamination.
Is the ARIES HSV 1&2 Assay compatible with any specific testing platform, and how does it differ from manual testing?
The ARIES HSV 1&2 Assay is designed exclusively for use on the ARIES M1 System, a fully automated nucleic acid testing platform. Unlike manual testing methods, this system automates extraction, purification, and amplification processes, reducing human error and improving efficiency while maintaining the assay’s real-time PCR-based detection capabilities.
What regulatory pathway does the ARIES HSV 1&2 Assay follow, and what does this mean for its use?
The ARIES HSV 1&2 Assay follows the FDA 510(k) clearance pathway, classified as a Class II device under regulation 866.3309. This means it has been determined to be substantially equivalent to a legally marketed predicate device and is governed by FDA compliance standards, ensuring its safety, effectiveness, and performance for qualitative detection of HSV-1 and HSV-2 DNA in clinical specimens.
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 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 ..., PDF SS19725.ARIES.HSV1&2.EUIVD-SS1459.0216 - trillium.de
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K151906 | Class II | Active |
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Manufacturer
- Manufacturer
- Luminex Corporation
Sources (1)
- FDA 510(k) K151906 24 fields · synced Oct 6, 2026