# K252329: QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B - Pathway: 510(k) (Traditional) - Applicant: QIAGEN GmbH - Decided: Oct 22, 2025 after 89 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: 4 generations back to DEN130003 (2013). 5 ancestors in all. 1 later device descends from it; 1 cites 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) - K220062: QIAstat-Dx Gastrointestinal Panel 2, QIAGEN GmbH (2024) Summary page 6. - K243813: QIAstat-Dx GI Panel 2 Mini B&V, QIAGEN GmbH (2025) Summary page 6. - K250324: QIAstat-Dx GI Panel 2 Mini B, QIAGEN GmbH (2025) Summary page 6. ## Most influential descendants - 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 QIAstat-Dx Gastrointestinal Panel 2 The QIAstat-Dx Gastrointestinal Panel 2 is a multiplexed nucleic acid test intended for use with the QIAstat-Dx Analyzer 2.0 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: • Adenovirus F40/F41 • Astrovirus • Norovirus GI/GII • Rotavirus A • Campylobacter (C. jejuni, C. coli and C. upsaliensis) • Shigella/Enteroinvasive Escherichia coli (EIEC) • Enteropathogenic Escherichia coli (EPEC) • Enterotoxigenic Escherichia coli (ETEC) lt/st • Shiga-like toxin-producing Escherichia coli (STEC) stx1/stx2 (including specific identification of E. coli O157 serogroup within STEC) • Salmonella • Plesiomonas shigelloides • Yersinia enterocolitica • Cryptosporidium • Cyclospora cayetanensis • Entamoeba histolytica • Giardia lamblia* *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. QIAstat-Dx GI Panel 2 Mini B&V The QIAstat-Dx GI Panel 2 Mini B&V is a multiplexed nucleic acid test intended for use with the QIAstat-Dx Analyzer 2.0 for the simultaneous in vitro qualitative detection and identification of nucleic acids from multiple bacteria and one virus directly from preserved stool samples (Para-Pak C&S or FecalSwab) obtained from individuals with signs and/or symptoms of gastrointestinal infection. The following virus and bacteria (including several diarrheagenic E. coli/Shigella pathotypes) are identified with the QIAstat-Dx GI Panel 2 Mini B&V: • Norovirus • Campylobacter • Shigella • Shiga-like toxin E. coli (STEC) • Salmonella Concomitant culture is necessary for organism recovery and further typing of bacterial agents. The QIAstat-Dx GI Panel 2 Mini B&V 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 GI Panel 2 Mini B&V. The organisms detected may not be the sole or definitive cause of the disease. Negative QIAstat-Dx GI Panel 2 Mini B&V 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. QIAstat-Dx GI Panel 2 Mini B The QIAstat-Dx GI Panel 2 Mini B is a multiplexed nucleic acid test intended for use with the QIAstat-Dx Analyzer 2.0. for the simultaneous in vitro qualitative detection and identification of nucleic acids from multiple bacteria directly from preserved stool samples (Para-Pak C&S or FecalSwab) obtained from individuals with signs and/or symptoms of gastrointestinal infection. The following bacteria (including several diarrheagenic E. coli/ Shigella pathotypes) are identified with the QIAstat-Dx GI Panel 2 Mini B: • Campylobacter • Shigella • Shiga-like toxin Escherichia coli (STEC) • Salmonella • Yersinia enterocolitica Concomitant culture is necessary for organism recovery and further typing of bacterial agents. The QIAstat-Dx GI Panel 2 Mini B 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 GI Panel 2 Mini B. The organisms detected may not be the sole or definitive cause of the disease. Negative QIAstat-Dx GI Panel 2 Mini B 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/K252329 Methodology: https://510kreport.com/methodology