ARIES System
FDA 510(k) K151917 · Luminex Corporation
510(k) numberK151917
Submission
- Device name
- ARIES System
- Applicant
- Luminex Corporation
Austin, TX, US - Received
- July 13, 2015
- Decision date
- October 6, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- OOI – Real Time Nucleic Acid Amplification System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.2570
- Specialty
- Clinical Chemistry
The system is a clinical multiplex instrument intended to measure and sort multiple signals generated my multiple probes, intercalating dyes, or other ligands in an assay from a clinical sample. Signals may be generated by fluorescence or other phenomena and may be measured using filters on a photodiode or other detector. It may integrate sample and/or reagent handling, amplification, dedicated…
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|---|---|---|
| K253722 | LIAISON PLEX Gastrointestinal Flex AssayPCH · Traditional | 05/19/2026SE |
| K243490 | LIAISON PLEX Gram-Positive Blood Culture AssayPAM · Traditional | 06/06/2025SE |
| K243013 | LIAISON PLEX Gram-Negative Blood Culture AssayPEN · Traditional | 04/18/2025SE |
| K240627 | LIAISON PLEX Yeast Blood Culture AssayPEO · Traditional | 06/04/2024SE |
| K233410 | LIAISON PLEX Respiratory Flex AssayQOF · Traditional | 03/01/2024SE |
| K191742 | ARIES MRSA AssayNQX · Traditional | 09/25/2019SE |
| K172402 | ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File KitPGX · Traditional | 10/30/2017SE |
| K171441 | ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES…OZN · Traditional | 07/21/2017SE |
| K163626 | ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File KitOZZ · Traditional | 05/02/2017SE |
| K162772 | ARIES GBS AssayNJR · Traditional | 12/23/2016SE |
Questions and answers
When was ARIES System cleared by the FDA?
ARIES System (K151917) received a 510(k) decision of Substantially Equivalent on October 6, 2015, 85 days after the submission was received.
What is the product code of K151917?
The FDA product code is OOI – Real Time Nucleic Acid Amplification System, a Class II (moderate risk) device regulated under 21 CFR 862.2570.