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Verigene Enteric Pathogen Nucleic Acid Test (EP)

by Nanosphere, Inc. 510(k)

Active United States

510(k) K140083

Overview

The Verigene Enteric Pathogen Nucleic Acid Test (EP) is a multiplex nucleic acid-based assay system for detecting and identifying enteric pathogens. It performs qualitative detection of common pathogenic bacteria, viruses, and genetic virulence markers in stool samples, enabling simultaneous identification of multiple targets in a single test. This device falls under the classification of a Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System, as defined by regulatory nomenclature.

The test is designed for use in microbiology laboratories and is intended for liquid or soft stool samples preserved in Cary-Blair medium. It is a single-use, in vitro diagnostic device and requires no additional sterilization or reprocessing. The Verigene EP has received FDA 510(k) clearance under the Traditional pathway, with a decision classification of Substantially Equivalent (SESE). The device operates within the regulatory framework of 21 CFR 866.3990 and is categorized under product code PCH for microbiology applications.

AI-generated from registry data, 20 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

Recall ongoing. 4 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK140083 Date20 Jun 2014ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

5 recalls · 4 ongoing · FDA

    • Ongoing Z-2023-2023 FDA Class II initiated 5 Jun 2023

    It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit (Part No. 20-005-023) could provide a false-negative result due to hydrophobic characteristics in specific FLOQSwab lots.

    • Ongoing Z-2451-2021 FDA Class II initiated 3 Aug 2021

    There is potential for false positive results.

    • Ongoing Z-1488-2021 FDA Class II initiated 18 Mar 2021

    Potential for a false-negative result for Vibrio parahaemolyticus, Salmonella, and/or Shigella spp when used with the VERIGENE Enteric Pathogens Nucleic Acid Test Kit.

    • Ongoing Z-2009-2021 FDA Class II initiated 30 Oct 2020 via K140083, on the same 510(k)

    Potential for a false-negative result.

    • Terminated Z-2685-2014 FDA Class II initiated 10 Oct 2013

    Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed on the Processor SP caused by Tips in Tip Holder Assemblies for the following products and lots of Extraction Trays.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

510(k)

510(k) Number
FDA Product Code
PCH
Device Class
Class II
Regulation
21 CFR Part 866.3990
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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