510(k) K243625
K243625 is an FDA 510(k) premarket notification submitted by Cepheid® for the device "Xpert MRSA/SA SSTI". The FDA issued a decision of Substantially Equivalent on December 18, 2024. The device falls under product code NQX (System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen), a Class II device regulated under 21 CFR 866.1640. Cepheid® has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 18, 2024
- Date Received
- November 25, 2024
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
- Device Class
- Class II
- Regulation Number
- 866.1640
- Review Panel
- MI
- Submission Type
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.