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IVD System Receives FDA Clearance and CE Mark

July 6, 2016 By Luminex Corporation

Luminex Corp. has received FDA clearance and CE-IVD marking for the ARIES M1 in vitro diagnostic system.

Designed for lower throughput clinical labs, system is a fully integrated, sample-to-answer platform for performing real-time polymerase chain reaction (PCR) assays.

The ARIES M1 is designed to empower satellite clinical laboratories to take advantage of the same options as the company’s higher throughput ARIES system, with features such as an intuitive system interface, STAT or batch testing, and true walkaway capability.

(ARIES systems are designed to increase laboratory efficiency, ensure result accuracy, and fit into today’s lean laboratory. (Credit: Luminex Corp.)

It extracts, amplifies and detects nucleic acid targets from a variety of sample types. Once the cassettes are loaded onto the instrument, results are generated without additional technical intervention.

Up to six different samples, and one to six assays, can be processed at a time.

The ARIES systems are sample to answer molecular diagnostic platforms designed to fit into lean laboratory environments. They use internal barcode scanning and other advanced features to minimize operator errors.

An integrated touchscreen PC eliminates the need for a separate computer, standalone keyboard, and mouse, maximizing bench space.

The low throughput ARIES M1 provides one module with the ability to run one to six different assays. The higher throughput ARIES provides two independent modules, each supporting from one to six cassettes, allowing for both STAT and batch testing of IVD and homebrew assays.

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