Cleared Special

K250995 - Xpert Xpress CoV-2/Flu/RSV plus

K250995 is an FDA 510(k) clearance for Xpert Xpress CoV-2/Flu/RSV plus, manufactured by Cepheid. The device is a Class 2 Microbiology device with product code QOF cleared through the Special 510(k) pathway after a 30-day FDA review.

K250995 · Cepheid · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
30d
Days
Class 2
Risk

K250995 is an FDA 510(k) clearance for the Xpert Xpress CoV-2/Flu/RSV plus. Classified as Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents (product code QOF), Class II - Special Controls.

Submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on May 1, 2025 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3981 - the FDA microbiology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K250995

510(k) Number K250995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2025
Decision Date May 01, 2025
Days to Decision 30 days
Submission Type Special
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
72d faster than avg
Panel avg: 102d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

QOF Device Classification - Class 2, Special Controls

Product Code QOF Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3981
Definition A Device To Detect And Identify Nucleic Acid Targets In Respiratory Specimens From Microbial Agents That Cause The Sars-cov-2 Respiratory Infection And Other Microbial Agents When In A Multi-target Test Is An In Vitro Diagnostic Device Intended For The Detection And Identification Of Sars-cov-2 And Other Microbial Agents When In A Multi-target Test In Human Clinical Respiratory Specimens From Patients Suspected Of Respiratory Infection Who Are At Risk For Exposure Or Who May Have Been Exposed To These Agents. The Device Is Intended To Aid In The Diagnosis Of Respiratory Infection In Conjunction With Other Clinical, Epidemiologic, And Laboratory Data Or Other Risk Factors.
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 Peers - QOF Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents

All 37
Devices cleared under the same product code (QOF) and FDA review panel - the closest regulatory comparables to K250995.
QIAstat-Dx Respiratory Panel Plus
K250080 · QIAGEN GmbH · Aug 2025
BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini
K243544 · Biofire Diagnostics, LLC · Aug 2025
cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems
K243455 · Roche Molecular Systems, Inc. · Jul 2025
Xpert Xpress CoV-2/Flu/RSV plus
K250996 · Cepheid · May 2025
cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test
K243400 · Roche Molecular Systems, Inc. · Apr 2025
cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test
K243406 · Roche Molecular Systems, Inc. · Apr 2025
K250995 · Xpert Xpress CoV-2/Flu/RSV plus
Download PDF FDA Summary Cepheid