QIAstat-Dx BCID GPF Plus AMR Panel
FDA 510(k) clearance K254194 · decided 2026-08-06
Clearance details
- K-number
- K254194
- Device name
- QIAstat-Dx BCID GPF Plus AMR Panel
- Applicant
- QIAGEN GmbH
- Decision
- Substantially Equivalent
- Date received
- 2025-12-23
- Decision date
- 2026-08-06
- Days to decision
- 226 days
- Clearance type
- Traditional
- Product code
- PAM
- Device class
- 2
- Regulation number
- 866.3365
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Hilden, DE
- Third-party review
- No
- Expedited review
- No
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| ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel (K181663) | Genmark Diagnostics, Incorporated | 2018-12-20 |
| iC-GPC Assay TM for use on the iC-SystemTM (K163390) | Icubate, Inc. | 2017-08-08 |
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| VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST (K122514) | Nanosphere, Inc. | 2012-09-19 |
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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 |