Cleared Traditional

K254194 - QIAstat-Dx BCID GPF Plus AMR Panel

K254194 is an FDA 510(k) clearance for QIAstat-Dx BCID GPF Plus AMR Panel, manufactured by QIAGEN GmbH. The device is a Class 2 Microbiology device with product code PAM cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K254194 · QIAGEN GmbH · Microbiology device
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Aug 2026
Decision
226d
Days
Class 2
Risk

K254194 is an FDA 510(k) clearance for the QIAstat-Dx BCID GPF Plus AMR Panel. Classified as Gram-positive Bacteria And Their Resistance Markers (product code PAM), Class II - Special Controls.

Submitted by QIAGEN GmbH (Hilden, DE). The FDA issued a Cleared decision on August 6, 2026 after a review of 226 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3365 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all QIAGEN GmbH devices

FDA 510(k) Submission Details - K254194

510(k) Number K254194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2025
Decision Date August 06, 2026
Days to Decision 226 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
124d slower than avg
Panel avg: 102d · This submission: 226d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PAM Device Classification - Class 2, Special Controls

Product Code PAM Gram-positive Bacteria And Their Resistance Markers
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3365
Definition A Qualitive Multiplexed In Vitro Diagnostic Device To Detect And Identify Gram Positive Bacteria And Resistant Markers In Positive Blood Cultures.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Consultant

Qiagen
Pamela Nge

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - PAM Gram-positive Bacteria And Their Resistance Markers

Devices cleared under the same product code (PAM) and FDA review panel - the closest regulatory comparables to K254194.
LIAISON PLEX Gram-Positive Blood Culture Assay
K243490 · Luminex Corporation · Jun 2025
ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel
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K163390 · Icubate, Inc. · Aug 2017
Great Basin Staph ID/R Blood Culture Panel
K152470 · Great Basin Scientific, Inc. · Mar 2016
VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST
K122514 · Nanosphere, Inc. · Sep 2012
VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP)
DEN120014 · Nanosphere, Inc. · Jun 2012