Cleared Traditional

K253653 - Xpert Hemorrhagic Fever (FDA 510(k) Clearance)

K253653 · Cepheid · Microbiology device
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Feb 2026
Decision
92d
Days
-
Risk

K253653 is an FDA 510(k) clearance for the Xpert Hemorrhagic Fever.

Submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on February 20, 2026 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel. 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.

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Submission Details

510(k) Number K253653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2025
Decision Date February 20, 2026
Days to Decision 92 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
10d faster than avg
Panel avg: 102d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -