# K163652: ePlex Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Genmark Diagnostics, Incorporated
- Decided: Jun 9, 2017 after 168 days
- Product code: NSU (Instrumentation For Clinical Multiplex Test Systems)
- Device class: 2
- Regulation: 21 CFR 862.2570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) BioFire Diagnostics FilmArray 2.0: named in the summary without a submission number

## Indications for use
The ePlex Instrument is an automated in vitro diagnostic (IVD) device designed to perform multiplexed nucleic acid tests for the simultaneous detection and identification of nucleic acid targets by processing single-use cartridges developed and manufactured by GenMark Diagnostics, Inc.

Source page: https://510kreport.com/device/K163652
Methodology: https://510kreport.com/methodology