510(k) K254194
K254194 is an FDA 510(k) premarket notification submitted by QIAGEN GmbH for the device "QIAstat-Dx BCID GPF Plus AMR Panel". The FDA issued a decision of Substantially Equivalent on August 6, 2026. The device falls under product code PAM (Gram-Positive Bacteria And Their Resistance Markers), a Class II device regulated under 21 CFR 866.3365. QIAGEN GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 6, 2026
- Date Received
- December 23, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gram-Positive Bacteria And Their Resistance Markers
- Device Class
- Class II
- Regulation Number
- 866.3365
- Review Panel
- MI
- Submission Type
A qualitive multiplexed in vitro diagnostic device to detect and identify Gram positive bacteria and resistant markers in positive blood cultures.