ePlex Instrument

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 22 Oct 2026.

Trade Name

ePlex Instrument EUDAMED

ePlex GUDID

Generic Name

Nucleic acid sequence analyser IVD, next-generation sequencing (NGS)

Model / Reference

RM003001 EUDAMED

ePlex System Base GUDID

Primary DI / UDI-DI

00857167005009

Basic UDI-DI

0857167005RM0030017M

Direct Marketing DI

00857167005009

510(k) Number

K163652 ↗

FDA Product Code

NSU

EMDN Code

W02050116 Nucleic acid testing integrated extraction /amplification /detection systems

GMDN Term

Nucleic acid sequence analyser IVD, next-generation sequencing (NGS)

Device Class

Class A EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 862.2570

EU market of registration

Netherlands

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

• Eplex Blood Culture Identification Fungal Pathogen BCID-FP Panel

  Class II

  FDA 510(k) K182690 Active Cleared 21 Dec 2018

• ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel

  Class II

  FDA 510(k) K213236 Active Cleared 27 Apr 2022

• eSensor Warfarin Sensitivity Saliva Test

  Class II

  FDA 510(k) K152612 Active Cleared 26 May 2016

• ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel

  Class II

  FDA 510(k) K181663 Active Cleared 20 Dec 2018

• ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel

  Class II

  FDA 510(k) K182619 Active Cleared 12 Apr 2019

• What types of tests can the ePlex Instrument perform, and how does its multiplexing capability benefit clinical workflows?

  The ePlex Instrument automates nucleic acid testing through single-use cartridges, enabling multiplexed assays to detect and identify multiple targets simultaneously for infectious disease, respiratory panels, and other molecular applications. This capability streamlines workflows by reducing turnaround time, minimizing sample handling, and improving diagnostic efficiency for conditions like respiratory infections or pathogen identification.

• Is the ePlex Instrument itself reusable, or are all components designed for single-use?

  The ePlex Instrument itself is a reusable clinical chemistry device intended for use in clinical laboratories. However, single-use cartridges are required for each assay, ensuring no cross-contamination and simplifying validation and maintenance processes as outlined in the manufacturer’s guidelines.

• What storage and handling requirements should laboratories follow for the ePlex Instrument?

  The ePlex Instrument follows standard laboratory practices for molecular diagnostic equipment, as specified by the manufacturer. While it is not sterile or MRI-safe, proper storage and handling—including environmental controls, calibration, and maintenance—are critical to ensure accurate and reliable performance. Always adhere to the manufacturer’s validation protocols.

• What regulatory pathways does the ePlex Instrument follow, and how does this affect its use in clinical settings?

  The ePlex Instrument is authorized under FDA 510(k) clearance (K163652) and IVDR compliance, classified as Non-Significant Risk (NSU) under 21 CFR 862.2570. This means it is governed by standard clinical chemistry regulations, ensuring its use in laboratories adheres to established safety and performance standards without additional restrictions beyond routine validation and maintenance.