BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid
FDA 510(k) clearance K243885 · decided 2025-01-16
Clearance details
- K-number
- K243885
- Device name
- BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid
- Applicant
- Biofire Diagnostics, LLC
- Decision
- Substantially Equivalent
- Date received
- 2024-12-18
- Decision date
- 2025-01-16
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- PCH
- Device class
- 2
- Regulation number
- 866.3990
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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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 |
| QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B (K254032) | QIAGEN GmbH | 2026-03-09 |
| 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 |
| 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.