# K220062: QIAstat-Dx Gastrointestinal Panel 2

- Pathway: 510(k) (Traditional)
- Applicant: QIAGEN GmbH
- Decided: May 31, 2024 after 872 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN130003 (2013). 2 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140407: Filmarray Gastrointestinal (GI) Panel, Biofire Diagnostics (2014) Summary page 5.

## Most influential descendants
- K250324: QIAstat-Dx GI Panel 2 Mini B (2025), 2 descendants of its own
- K243813: QIAstat-Dx GI Panel 2 Mini B&V (2025), 2 descendants of its own
- K252329: QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B (2025), 1 descendant of its own
- K254032: QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B (2026), 0 descendants of its own

## Indications for use
The QIAstat-Dx Gastrointestinal Panel 2 is a multiplexed nucleic acid test intended for use with the QIAstat-Dx Analyzer 1.0. for the simultaneous in vitro qualitative detection and identification of nucleic acids from multiple viruses, bacteria, and parasites directly from preserved stool samples (Para-Pak C&S or FecalSwab) obtained from individuals with signs and/or symptoms of gastrointestinal infection. The following viruses, bacteria (including several diarrheagenic E. coli/Shigella pathotypes), and parasites are identified with the QIAstat-Dx Gastrointestinal Panel 2 : Pathogen Para-Pak C&S FecalSwab * Adenovirus F40/F41 Reported Reported * Astrovirus Reported Reported * Norovirus GI/GI1 Reported Reported * Rotavirus A Reported Reported » Campylobacter (C. jejuni, C. coli and C. upsaliensis) Reported Reported » Shigella/Enteroinvasive Escherichia coli (EIEC) Reported Reported * Enteropathogenic Escherichia coli (EPEC) Reported Not Reported * Enterotoxigenic Escherichia coli (ETEC) It/st Reported Reported » Shiga-like toxin-producing Escherichia coli (STEC) stx1/stx2 Reported Not Reported (including specific identification of E. coli O157 serogroup within STEC) * Salmonella Reported Reported * Plesiomonas shigelloides Reported Reported * Yersinia enterocolitica Reported Reported * Cryptosporidium Reported Reported * Cyclospora cayetanensis Reported Reported * Entamoeba histolytica Reported Reported * Giardia lamblia* Reported Reported *(Also known as Giardia intestinalis and Giardia duodenalis) Concomitant culture is necessary for organism recovery and further typing of bacterial agents. The QIAstat-Dx Gastrointestinal Panel 2 is indicated as an aid in the diagnosis of specific agents of gastrointestinal illness, in conjunction with other clinical, laboratory, and epidemiological data. Positive results do not rule-out co-infection with organisms not detected by the QIAstat-Dx Gastrointestinal Panel 2. The organisms detected may not be the sole or definitive cause of the disease. Negative QIAstat-Dx Gastrointestinal Panel 2 results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this assay test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn’s disease.

Source page: https://510kreport.com/device/K220062
Methodology: https://510kreport.com/methodology