ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)
FDA 510(k) K161495 · Luminex Corporation
Submission
- 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
Austin, TX, US - Received
- June 1, 2016
- Decision date
- June 30, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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Questions and answers
When was ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD) cleared by the FDA?
ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD) (K161495) received a 510(k) decision of Substantially Equivalent on June 30, 2016, 29 days after the submission was received.
What is the product code of K161495?
The FDA product code is OOI – Real Time Nucleic Acid Amplification System, a Class II (moderate risk) device regulated under 21 CFR 862.2570.