Cleared Special

K243625 - Xpert MRSA/SA SSTI (FDA 510(k) Clearance)

Class II Microbiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K243625 · Cepheid · Microbiology device
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Dec 2024
Decision
23d
Days
Class 2
Risk

K243625 is an FDA 510(k) clearance for the Xpert MRSA/SA SSTI. Classified as System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen (product code NQX), Class II - Special Controls.

Submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on December 18, 2024 after a review of 23 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.

View all Cepheid devices

Submission Details

510(k) Number K243625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2024
Decision Date December 18, 2024
Days to Decision 23 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
79d faster than avg
Panel avg: 102d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1640
Definition A Nucleic Acid Amplification Assay System (including Probes, Other Reagents, And Instrumentation) Is An Aid In The Identification Of Mrsa Colonization Status For The Prevention And Control Of Mrsa Infections In Healthcare Settings.
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.