510(k) · Cleared
Recalled · Class II · 2023Verigene Enteric Pathogen Nucleic Acid Test ( EP)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nanosphere, Inc. · PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Cleared on Jun 20, 2014 as substantially equivalent to K121894 (Luminex Molecular Diagnostics, Inc., 2013) after a 158-day review. Its family tree reaches back 1 generation to 2013. 1 later device descends from it. It has been recalled 5 times.
- Decided
- Jun 20, 2014
- Review
- 158 days
- Class
- Class II
- Product code
- PCH
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 1 generation to K121894 (2013). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK121894 Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis…Luminex Molecular Diagnostics, Inc. · 2013
- This deviceK140083 Verigene Enteric Pathogen Nucleic Acid Test ( EP)Nanosphere, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK163571 Great Basin Stool Bacterial Pathogens PanelGreat Basin Scientific, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K163571Great Basin Stool Bacterial Pathogens PanelGreat Basin Scientific, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K121894 | Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis Software for GPP… | Luminex Molecular Diagnostics, Inc. | 2013 | — |
| 0 (this device) | K140083 | Verigene Enteric Pathogen Nucleic Acid Test ( EP) | Nanosphere, Inc. | 2014 | — |
| +1 | K163571 | Great Basin Stool Bacterial Pathogens Panel | Great Basin Scientific, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PCH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PCH device
- #1 K220062 QIAstat-Dx Gastrointestinal Panel 2score 16.7 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K121894 | Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis Software for GPP (Tdas…Summary page 2…vice: NSU Instrumentation for clinical multiplex test systems JJH Clinical Sample Concentrator Predicate Devices: xTAG® Gastrointestinal Pathogen Panel (GPP) (K 121894) (Luminex Molecular Diagnostics, Inc.) Indications for Use: The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiple… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163571 | Great Basin Stool Bacterial Pathogens Panel | 2017 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 5, 2023 | Class II | Z-2023-2023 | Other | 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… |
| Aug 3, 2021 | Class II | Z-2451-2021 | Process control | There is potential for false positive results. |
| Mar 18, 2021 | Class II | Z-1488-2021 | Process control | 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 | Device Design | Potential for a false-negative result. |
| Oct 10, 2013 | Class II | Z-2685-2014 | Nonconforming Material/Component | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All PCH devicesPCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · PCH
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PCH
89in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PCH
5in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PCH
40in 2025
MAUDE reports naming product code PCH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 3 | — | 0 | 0 |
| 2014 | 6 | 120 | 0 | 1 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 4 | 105 | 0 | 0 |
| 2019 | 4 | 191 | 0 | 4 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 26 |
| 2022 | 2 | — | 0 | 47 |
| 2023 | 1 | — | 1 | 62 |
| 2024 | 3 | 271 | 0 | 45 |
| 2025 | 7 | 89 | 5 | 40 |
| 2026 | 3 | 176 | 0 | — |
What is it indicated for?
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…
Read the full statement (341 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K140083 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140083: Verigene Enteric Pathogen Nucleic Acid Test ( EP).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140083
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026