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The Luminex® ARIES® M1 System is an in vitro diagnostic (IVD) platform that performs nucleic acid based tests in clinical laboratories. The Luminex ARIES® M1 System is capable of automated extraction and purification of nucleic acids from multiple sample types as well as the automated amplification of target nucleic acid sequences by fluorescence-based PCR.

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This document is a FDA clearance letter for the Luminex ARIES® M1 System, an in vitro diagnostic (IVD) platform. It primarily describes the regulatory approval rather than a detailed study proving the device meets specific acceptance criteria with performance metrics.

Therefore, the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, and specific study designs (like MRMC or standalone performance) is not available within the provided text.

The document states the "ARIES® M1 System is an in vitro diagnostic (IVD) platform that performs nucleic acid based tests in clinical laboratories" and that it "is capable of automated extraction and purification of nucleic acids from multiple sample types as well as the automated amplification of target nucleic acid sequences by fluorescence-based PCR." This is a description of its capabilities rather than performance statistics.

To answer your request, a detailed performance study report from Luminex Corporation would be required, which is typically a separate document submitted to the FDA as part of the 510(k) application, but not included in this clearance letter.

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