ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)

K161495 · Luminex Corporation · OOI · Jun 30, 2016 · Clinical Chemistry

Device Facts

• Record ID: K161495
• Device Name: ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)
• Applicant: Luminex Corporation
• Product Code: OOI · Clinical Chemistry
• Decision Date: Jun 30, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.2570
• Device Class: Class 2

Indications for Use

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.

Device Story

Luminex ARIES M1 System is a modified version of the ARIES System designed for lower-throughput laboratories; reduces processing capacity from 12 assays to 6 assays. Device performs automated nucleic acid extraction, purification, and real-time PCR amplification/detection. Operated by laboratory personnel in clinical settings. Input consists of clinical samples loaded into assay cassettes; system processes samples via automated lysis and PCR. Output is automated test result interpretation displayed on a 12.1-inch LCD touchscreen. System utilizes interchangeable assay processing modules. Benefits include providing a smaller footprint and lower throughput option for clinical diagnostic testing while maintaining the fundamental scientific technology of the predicate ARIES system.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and performance testing of the platform's automated extraction and amplification capabilities.

Technological Characteristics

Automated IVD platform; performs nucleic acid extraction, purification, and fluorescence-based PCR amplification. System utilizes fluorescence detection for target sequence identification. Designed for clinical laboratory environment.

Indications for Use

Indicated for use in clinical laboratories as an IVD platform for automated nucleic acid extraction, purification, and fluorescence-based PCR amplification of target sequences.

Regulatory Classification

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.

Special Controls

*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.

The special control is FDA's guidance document entitled "Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems."

Predicate Devices

• Luminex ARIES System (K160517)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Decision Memorandum

To: THE FILE

RE: K161495 - Luminex AIRES® System

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable:

1. The name and 510(k) number of the SUBMITTER'S previously cleared device.
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATIONS, including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for modifications to the ARIES System to produce the ARIES M1 System with a reduced throughput. The ARIES System has the capacity to process up to 12 assays at a given time and the ARIES M1 System (modified device) will have the capacity to process up to 6 assays at a given time to address the needs of lower throughput laboratories.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and software is shown in the table below:

| Device & Predicate Device: | K161495 | K160517 (Predicate) |
| --- | --- | --- |
| General Device Characteristics | | |
| Indications For Use | The Luminex® ARIES® M1 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. | The Luminex® ARIES® 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 and detection of target nucleic acid sequences by fluorescence-based PCR. |
| Sample Preparation Method | Same | Automated nucleic acid lysis and extraction by the ARIES System |
| Assay Format | Same | Amplification: Real Time PCR Detection: Fluorogenic |

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K161495

| Device & Predicate Device: | K161495 | K160517 (Predicate) |
| --- | --- | --- |
| Assay Controls | Same | Sample Processing Control (SPC) |
| Test Results Interpretation | Same | Automated (ARIES Software) |
| # of Assay Processing Modules | One assay processing module | Two (up to 12 cassette capacity). NOTE: Assay processing modules are interchangeable between systems |
| Hardware User Interface | Chassis sized to fit one assay processing module and a 12.1” LCD touchscreen | Chassis sized to fit two assay processing modules and a large touchscreen |
| Software User Interface | Chassis sized to fit one assay processing module and a 12.1” LCD touchscreen | Scaled to fit large ARIES System touchscreen |

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied

Risk analysis was performed to identify risks, their possible causes, and appropriate control mechanisms. The risk analysis identified no additional hazards, no additional causes, and no required additional controls.

The following studies were performed to validate the modified ARIES System and ensure the design outputs met the design input requirements:

- One study focused on user experience when interfacing with the ARIES M1 System. The study consisted of three operators executing a prescribed protocol on three separate ARIES M1 Systems in a user-simulated environment and completing a survey of their use experience. The study concluded that user needs were met when the ARIES M1 System was run in a user-simulated environment.
- Precision and method comparison testing was performed by testing two lots of ARIES HSV 1&2 Assay Cassettes on four ARIES instruments (three M6V1 instruments (new) and one M12V6 instrument (old)) with two operators across 10 days with a total of 809 replicates. The panel used in this study was prepared with a moderate positive and low positive independently for HSV-1 and HSV-2 as well as a negative sample. The results of the precision and method comparison studies demonstrate 100% agreement between all 809 replicates tested by both operators across four ARIES instruments, three ARIES M1 Systems and one ARIES System.
- Further, the precision in Tm (melting temperature) on the ARIES M1 System was evaluated. The standard deviation in adjusted Tm for HSV-1 moderate positive and HSV-1 low positive samples on each ARIES M1 System was 0.2. The standard deviation in adjusted Tm for HSV-2 moderate positive and HSV-2 low positive samples on each ARIES M1 System was 0.2, and the standard deviation in SPC Tm for HSV-1 and HSV-2 negative samples for each ARIES M1 System was ≤0.3.

6. The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the

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K161495

submitter's description of the particular modifications and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared device.

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