(48 days)
The Luminex ARIES® System is an in vitro diagnostic (IVD) platform that performs nucleic acid based tests in clinical laboratories. The Luminex ARIES® System is capable of automated extraction and purification of nucleic acids from multiple sample types as well as the automated amplification and detection of target nucleic acid sequences by fluorescence-based PCR.
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I am sorry, but the provided text does not contain information about acceptance criteria, device performance tables, sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC study results, standalone performance, type of ground truth used, or details about the training set for the ARIES® System. The document is an FDA 510(k) clearance letter and an Indications for Use statement, which primarily confirm regulatory approval and describe the system's intended function.
§ 862.2570 Instrumentation for clinical multiplex test systems.
(a)
Identification. Instrumentation for clinical multiplex test systems is a device intended to measure and sort multiple signals generated by an assay from a clinical sample. This instrumentation is used with a specific assay to measure multiple similar analytes that establish a single indicator to aid in diagnosis. Such instrumentation may be compatible with more than one specific assay. The device includes a signal reader unit, and may also integrate reagent handling, hybridization, washing, dedicated instrument control, and other hardware components, as well as raw data storage mechanisms, data acquisition software, and software to process detected signals.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems.” See § 862.1(d) for the availability of this guidance document.