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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gram-Positive Bacteria And Their Resistance Markers
510(k) Number K254194
Device Name QIAstat-Dx BCID GPF Plus AMR Panel
Applicant
QIAGEN GmbH
Qiagen Strasse 1
Hilden,  DE 40724
Applicant Contact Kristen Kanack
Correspondent
Qiagen
19300 Germantown Rd.
Germantown,  MD  20874
Correspondent Contact Pamela Nge
Regulation Number866.3365
Classification Product Code
PAM  
Subsequent Product Codes
PEN   PEO  
Date Received12/23/2025
Decision Date 08/06/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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