xTAG Gastrointestinal Pathogen Panel (GPP)
FDA 510(k) clearance K191161 · decided 2019-11-12
Clearance details
- K-number
- K191161
- Device name
- xTAG Gastrointestinal Pathogen Panel (GPP)
- Applicant
- Luminex Molecular Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-05-01
- Decision date
- 2019-11-12
- Days to decision
- 195 days
- Clearance type
- Special
- Product code
- PCH
- Device class
- 2
- Regulation number
- 866.3990
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Toronto, CA
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| LIAISON PLEX Gastrointestinal Flex Assay (K253722) | Luminex Corporation | 2026-05-19 |
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| 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 |
Recalls involving this device
No recalls on record reference this clearance.