Cleared Special

Xpert? SA Nasal Complete

K243070 · Cepheid · Microbiology

Oct 2024

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K243070 is an FDA 510(k) clearance for the Xpert? SA Nasal Complete, 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 October 25, 2024, 28 days after receiving the submission on September 27, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number	K243070 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 27, 2024
Decision Date	October 25, 2024
Days to Decision	28 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.