# K140083: Verigene Enteric Pathogen Nucleic Acid Test ( EP)

- Pathway: 510(k) (Traditional)
- Applicant: Nanosphere, Inc.
- Decided: Jun 20, 2014 after 158 days
- Product code: PCH (Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System)
- Device class: 2
- Regulation: 21 CFR 866.3990
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K121894 (2013). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121894: Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis Software for GPP (Tdas GPP) Luminex Magpix, Luminex Molecular Diagnostics, Inc. (2013) Summary page 2.

## Most influential descendants
- K163571: Great Basin Stool Bacterial Pathogens Panel (2017), 0 descendants of its own

## Recalls of this device
- Jun 5, 2023 · Class II · Z-2023-2023: 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-
- Aug 3, 2021 · Class II · Z-2451-2021: There is potential for false positive results.
- Mar 18, 2021 · Class II · Z-1488-2021: 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.
- Oct 30, 2020 · Class II · Z-2009-2021: Potential for a false-negative result.
- Oct 10, 2013 · Class II · Z-2685-2014: 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 pro

## Indications for use
The Verigenet Enteric Pathogenis Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria and genetic virulence markers from liquid or soft stool preserved in Cary-Blair media, collected from individuals with signs and symptoms of gastrointestinal infection. The test is performed on the automated Nanosphere Verigene System utilizing reverse transcription (KRT, polymerase chain reaction (PCR), and array hybridization to detect specific gastrointestinal microbial nucleic acid gene sequences associated with the following pathogenic bacteria: * Campylobacter Group (comprised of C. coli, C.jejuni, and C. Iari) * Salmonella species * Shigella species (including S. dysenteriae, S. boydii, S. sonnei, and S. flexneri) * Vibnioi Group (comprised of V. cholerue and V. parahaemolyticus) * Versinia enterocolitica In addition, EP detects the Shiga toxin I gene and Shiga toxin 2 gene virulence markers. Shiga toxin producing E. coli (STEC) typically harbor one or both genes that encode for Shiga Toxins I and 2. EP is indicated as an aid in the diagnosis of specific agents of gastrointestinal illness, in conjunction with other clinical, laboratory, and epidemiological information; however, is not to be used to monitor these infections. EP also aids in the detection and identification of acute gastroenteritis in the context of outbreaks. Due to the limited number of positive specimens collected for certain organisms during the prospective clinical study, performance characteristics for Yersinia enterocolitica, Vibrio Group and Shigella species were primarily established with contrived specimens. Concomitant culture is necessary for organism recovery and further typing of bacterial agents. EP results should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Confirmed positive results do not rule out co-infection with other organisms that are not detected by this test, and may not be the sole or definitive cause of patient illness. Negative EP results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease.

Source page: https://510kreport.com/device/K140083
Methodology: https://510kreport.com/methodology