Cleared Traditional

K262971 - Xpert® Hemorrhagic Fever Panel

K262971 is an FDA 510(k) clearance for Xpert Hemorrhagic Fever Panel, manufactured by Cepheid. The device is a Class 2 Microbiology device with product code QVR cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K262971 · Cepheid · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
65d
Days
Class 2
Risk

K262971 is an FDA 510(k) clearance for the Xpert® Hemorrhagic Fever Panel. Classified as Multiplex Nucleic Acid Detection System For Biothreat Agents (product code QVR), Class II - Special Controls.

Submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on October 30, 2026 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.4000 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K262971

510(k) Number K262971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2026
Decision Date October 30, 2026
Days to Decision 65 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
37d faster than avg
Panel avg: 102d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QVR Device Classification - Class 2, Special Controls

Product Code QVR Multiplex Nucleic Acid Detection System For Biothreat Agents
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.4000
Definition A Multiplex Nucleic Acid Detection System For Biothreat Agents Is A Qualitative In Vitro Diagnostic Test For Detection And Identification Of Nucleic Acids From Biothreat Pathogens In Human Clinical Specimens
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.

K262971 · Xpert® Hemorrhagic Fever Panel
Download PDF FDA Summary Cepheid