# K243813: QIAstat-Dx GI Panel 2 Mini B&V

- Pathway: 510(k) (Special)
- Applicant: QIAGEN GmbH
- Decided: Jan 8, 2025 after 28 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: 3 generations back to DEN130003 (2013). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 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 5.

## Most influential descendants
- 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 GI Panel 2 Mini B&V 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 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 Escherichia coli (STEC)* • Salmonella *Only with Para-Pak C&S, not reported for FecalSwab 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.

Source page: https://510kreport.com/device/K243813
Methodology: https://510kreport.com/methodology