QIAstat-Dx GI Panel 2 Mini B
FDA 510(k) K250324 · QIAGEN GmbH
Submission
- Device name
- QIAstat-Dx GI Panel 2 Mini B
- Applicant
- QIAGEN GmbH
Hilden, DE - Received
- February 5, 2025
- Decision date
- February 28, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PCH – Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3990
- Specialty
- Microbiology
A gastrointestinal pathogen panel multiplex nucleic acid 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 detection and identification of a specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and/or symptoms of gastrointestinal…
Other 510(k)s with product code PCH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253722 | LIAISON PLEX Gastrointestinal Flex AssayPCH · Traditional | Luminex Corporation | 05/19/2026SE |
| K254032 | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel…PCH · Traditional | QIAGEN GmbH | 03/09/2026SE |
| K251721 | Xpert GI PanelPCH · Traditional | Cepheid | 01/16/2026SE |
| K252329 | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel…PCH · Traditional | QIAGEN GmbH | 10/22/2025SE |
| K251993 | Panther Fusion GI Expanded Bacterial AssayPCH · Traditional | Hologic, Inc. | 09/25/2025SE |
| K251868 | Panther Fusion GI Bacterial AssayPCH · Traditional | Hologic | 09/25/2025SE |
| K243885 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel MidPCH · Special | Biofire Diagnostics, LLC | 01/16/2025SE |
| K242877 | BioCode Gastrointestinal Pathogen Panel (GPP)PCH · Traditional | Applied BioCode, Inc. | 01/10/2025SE |
| K243813 | QIAstat-Dx GI Panel 2 Mini B&VPCH · Special | QIAGEN GmbH | 01/08/2025SE |
| K242367 | BIOFIRE FILMARRAY Gastrointestinal (GI) PanelPCH · Traditional | Biofire Diagnostics, LLC | 11/07/2024SE |
More from Biofire Diagnostics, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K254194 | QIAstat-Dx BCID GPF Plus AMR PanelPAM · Traditional | 08/06/2026SE |
| K254032 | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel…PCH · Traditional | 03/09/2026SE |
| K252329 | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel…PCH · Traditional | 10/22/2025SE |
| K250080 | QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel MiniQOF · Traditional | 08/27/2025SE |
| K243813 | QIAstat-Dx GI Panel 2 Mini B&VPCH · Special | 01/08/2025SE |
| K242256 | QIAstat-Dx Meningitis/Encephalitis (ME) PanelPLO · Traditional | 10/29/2024SE |
| K242353 | QIAstat-Dx Respiratory Panel MiniQOF · Special | 10/25/2024SE |
| K220062 | QIAstat-Dx Gastrointestinal Panel 2PCH · Traditional | 05/31/2024SE |
| K233100 | QIAstat-Dx® Respiratory Panel PlusQOF · Traditional | 05/10/2024SE |
| K183597 | QIAstat-Dx Respiratory PanelOCC · Traditional | 05/18/2019SE |
Questions and answers
When was QIAstat-Dx GI Panel 2 Mini B cleared by the FDA?
QIAstat-Dx GI Panel 2 Mini B (K250324) received a 510(k) decision of Substantially Equivalent on February 28, 2025, 23 days after the submission was received.
What is the product code of K250324?
The FDA product code is PCH – Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System, a Class II (moderate risk) device regulated under 21 CFR 866.3990.