Cleared Special

Xpert MRSA/SA SSTI

K243625 · Cepheid · Microbiology

Dec 2024

Decision

23d

Days

Class 2

Risk

About This 510(k) Submission

K243625 is an FDA 510(k) clearance for the Xpert MRSA/SA SSTI, a System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen (Class II — Special Controls, product code NQX), submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on December 18, 2024, 23 days after receiving the submission on November 25, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number	K243625 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	NQX — System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Device Class	Class II — 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.