K243625 is an FDA 510(k) clearance for the Xpert MRSA/SA SSTI. This device is classified as 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 FDA review panel. Regulated under 21 CFR 866.1640. 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..
| 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 |
| 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. |