Cleared Dual Track

K261362 - Xpert Hemorrhagic Fever

K261362 is an FDA 510(k) clearance for Xpert Hemorrhagic Fever, manufactured by Cepheid. The device is a Class 2 Microbiology device with product code QVR cleared through the Dual Track 510(k) pathway after a 102-day FDA review.

K261362 · Cepheid · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
102d
Days
Class 2
Risk

K261362 is an FDA 510(k) clearance for the Xpert Hemorrhagic Fever. 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 August 7, 2026 after a review of 102 days - within the typical 510(k) review window.

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: 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 Cepheid devices

FDA 510(k) Submission Details - K261362

510(k) Number K261362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2026
Decision Date August 07, 2026
Days to Decision 102 days
Submission Type Dual Track
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
At panel average
Panel avg: 102d · This submission: 102d
Pathway characteristics

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Microbiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT07591740 Completed Observational Industry-sponsored

Xpert Hemorrhagic Fever on Edge X in Trained and Untrained Users

Comparison Study of the Xpert Hemorrhagic Fever Test Between Trained and Untrained Users on the GeneXpert Edge X System

725
Patients (actual)
1
Site
Condition studied Hemorrhagic Fever
Eligibility All sexes · 14 Years+ · Healthy volunteers accepted
Sponsor Cepheid (industry)
Started 2024-10-21 → Primary completion 2025-03-14 → Completed 2026-03-13
Primary outcome
Clinical Performance [PPA and NPA] of Xpert on Edge X in Untrained and Trained Users
Study completed - no results published. This trial concluded in 2026 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov