QIAstat-Dx GI Panel 2 Mini B

K250324 · QIAGEN GmbH · PCH · Feb 28, 2025 · Microbiology

Device Facts

• Record ID: K250324
• Device Name: QIAstat-Dx GI Panel 2 Mini B
• Applicant: QIAGEN GmbH
• Product Code: PCH · Microbiology
• Decision Date: Feb 28, 2025
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3990
• Device Class: Class 2

Indications for Use

The QIAstat-Dx® GI Panel 2 Mini B 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 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. *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 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.

Device Story

QIAstat-Dx GI Panel 2 Mini B is a multiplexed nucleic acid-based assay for gastrointestinal pathogen detection. Device processes human stool specimens via QIAstat-Dx Analyzer. Modification involves Assay Definition File (ADF) updates to mask specific analytes and revised reporting schemes for Shigella and Shiga-like toxin E. coli (STEC). System provides qualitative identification of gastrointestinal microorganisms to aid clinical diagnosis. Used in clinical laboratory settings by trained personnel. Output assists healthcare providers in managing patients with suspected gastrointestinal infections.

Clinical Evidence

Performance data is equivalent to the predicate device (K220062) for the five shared analytes. No new clinical data provided; substantial equivalence supported by verification and validation of the modified Assay Definition File (ADF).

Technological Characteristics

Multiplexed real-time PCR assay; silica membrane-based nucleic acid extraction; pneumatically operated microfluidics; pre-packaged reagents in single-use cartridges. Analyte detection via fluorescence. System includes QIAstat-Dx Analyzer 1.0. Software-controlled automated processing.

Indications for Use

Indicated for individuals with signs/symptoms of gastrointestinal infection for qualitative detection of Campylobacter, Shigella, STEC, Salmonella, and Yersinia enterocolitica from preserved stool samples (Para-Pak C&S or FecalSwab).

Regulatory Classification

Identification

A gastrointestinal microorganism multiplex nucleic acid-based assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from human stool specimens. The device detects specific nucleic acid sequences for organism identification as well as for determining the presence of toxin genes. The detection and identification of a specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings. A gastrointestinal microorganism multiplex nucleic acid-based assay also aids in the detection and identification of acute gastroenteritis in the context of outbreaks.

Special Controls

*Classification.* Class II (special controls). The special controls are set forth in FDA's guideline document entitled: “Class II Special Controls Guideline: Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assays for Detection and Identification of Microorganisms and Toxin Genes from Human Stool Specimens.” For availability of the guideline document, see § 866.1(e).

Predicate Devices

• QIAstat-Dx Gastrointestinal Panel 2 (K220062)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K250324

B Applicant

QIAGEN GmbH

C Proprietary and Established Names

QIAstat-Dx GI Panel 2 Mini B

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| PCH | Class II | 21 CFR 866.3990 - Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assay | MI - Microbiology |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.)
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. This change was for (1) modifications to the Assay Definition

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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File (ADF) to mask a subset of analytes, (2) a change to the reporting scheme for Shigella, and Shiga-like toxin E. coli (STEC). No new performance data were reviewed.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

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