ePlex Instrument
FDA 510(k) K163652 · Genmark Diagnostics, Incorporated
510(k) numberK163652
Submission
- Device name
- ePlex Instrument
- Applicant
- Genmark Diagnostics, Incorporated
Carlsbad, CA, US - Received
- December 23, 2016
- Decision date
- June 9, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NSU – Instrumentation For Clinical Multiplex Test Systems
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.2570
- Specialty
- Clinical Chemistry
Instrumentation for clinical multiplex test systems is a device that is intended to measure and sort multiple signals generated by an assay from a clinical sample. The generated signals from multiple probes or other ligands may be measured by fluorescence, luminescence, or other physical or chemical properties. The device may integrate scanning, reagent handling, hybridization, washing…
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More from Luminex Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K213236 | ePlex Blood Culture Identification Gram Negative (BCID-GN) PanelPEN · Traditional | 04/27/2022SE |
| K182619 | ePlex Blood Culture Identification Gram Negative (BCID-GN) PanelPEN · Traditional | 04/12/2019SE |
| K182690 | ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) PanelPEO · Traditional | 12/21/2018SE |
| K181663 | ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) PanelPAM · Traditional | 12/20/2018SE |
| K163636 | ePlex Respiratory Pathogen PanelOCC · Traditional | 06/09/2017SE |
| K152612 | eSensor Warfarin Sensitivity Saliva TestODW · Traditional | 05/26/2016SE |
| K110786 | Esensor Warfarin Sensitivity Saliva TestNSU · Traditional | 12/02/2011SE |
Questions and answers
When was ePlex Instrument cleared by the FDA?
ePlex Instrument (K163652) received a 510(k) decision of Substantially Equivalent on June 9, 2017, 168 days after the submission was received.
What is the product code of K163652?
The FDA product code is NSU – Instrumentation For Clinical Multiplex Test Systems, a Class II (moderate risk) device regulated under 21 CFR 862.2570.