510(k) K160901
K160901 is an FDA 510(k) premarket notification submitted by Cepheid for the device "Xpert Carba-R". The FDA issued a decision of Substantially Equivalent on June 29, 2016. The device falls under product code POC (System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, 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
- June 29, 2016
- Date Received
- April 1, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen
- Device Class
- Class II
- Regulation Number
- 866.1640
- Review Panel
- MI
- Submission Type
To detect the presence of genetic markers of antimicrobial resistance by testing directly from clinical specimens using nucleic acid amplification technology.