Cleared Special

K261867 - Xpert Carba-R

K261867 is the FDA 510(k) clearance for Xpert Carba-R by Cepheid. It is a Class 2 Microbiology device (product code POC) cleared through the Special 510(k) pathway after a 28-day FDA review.

K261867 · Cepheid · Microbiology device
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Jul 2026
Decision
28d
Days
Class 2
Risk

K261867 is an FDA 510(k) clearance for the Xpert Carba-R. Classified as System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen (product code POC), Class II - Special Controls.

Submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on July 2, 2026 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1640 - 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.

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Submission Details

510(k) Number K261867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2026
Decision Date July 02, 2026
Days to Decision 28 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
74d faster than avg
Panel avg: 102d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code POC System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1640
Definition To Detect The Presence Of Genetic Markers Of Antimicrobial Resistance By Testing Directly From Clinical Specimens Using Nucleic Acid Amplification Technology.
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.