QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B
FDA 510(k) clearance K254032 · decided 2026-03-09
Clearance details
- K-number
- K254032
- Device name
- QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B
- Applicant
- QIAGEN GmbH
- Decision
- Substantially Equivalent
- Date received
- 2025-12-16
- Decision date
- 2026-03-09
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- PCH
- Device class
- 2
- Regulation number
- 866.3990
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Hilden, DE
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch QIAGEN GmbH
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| LIAISON PLEX Gastrointestinal Flex Assay (K253722) | Luminex Corporation | 2026-05-19 |
| Xpert GI Panel (K251721) | Cepheid | 2026-01-16 |
| QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B (K252329) | QIAGEN GmbH | 2025-10-22 |
| Panther Fusion GI Bacterial Assay (K251868) | Hologic | 2025-09-25 |
| Panther Fusion GI Expanded Bacterial Assay (K251993) | Hologic, Inc. | 2025-09-25 |
| QIAstat-Dx GI Panel 2 Mini B (K250324) | QIAGEN GmbH | 2025-02-28 |
| BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid (K243885) | Biofire Diagnostics, LLC | 2025-01-16 |
| BioCode Gastrointestinal Pathogen Panel (GPP) (K242877) | Applied BioCode, Inc. | 2025-01-10 |
| QIAstat-Dx GI Panel 2 Mini B&V (K243813) | QIAGEN GmbH | 2025-01-08 |
| BIOFIRE FILMARRAY Gastrointestinal (GI) Panel (K242367) | Biofire Diagnostics, LLC | 2024-11-07 |
| QIAstat-Dx Gastrointestinal Panel 2 (K220062) | QIAGEN GmbH | 2024-05-31 |
| EasyScreen Gastrointestinal Parasite Detection Kit (K232672) | Genetic Signatures Limited | 2024-05-29 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| therascreen® PIK3CA RGQ PCR Kit (P190001/S002) | QIAGEN GmbH | 2025-10-22 |
| QIAGEN therascreen® FGFR RGQ RT-PCR Kit (P180043/S007) | QIAGEN GmbH | 2025-10-03 |
| therascreen® KRAS RGQ PCR Kit (P110027/S018) | QIAGEN GmbH | 2025-01-16 |
| therascreen FGFR RGQ PCR Kit (P180043/S008) | QIAGEN GmbH | 2024-12-06 |
| therascreen FGFR RGQ RT-PCR Kit (P180043/S009) | QIAGEN GmbH | 2024-10-23 |
| therascreen® KRAS RGQ PCR Kit (P110027/S017) | QIAGEN GmbH | 2024-06-21 |
| therascreen FGFR RGQ RT-PCR Kit (P180043/S006) | QIAGEN GmbH | 2023-12-22 |
| QIAGEN therascreen® KRAS RGQ PCR Kit (P110027/S016) | QIAGEN GmbH | 2023-10-06 |