K160901 is an FDA 510(k) clearance for the Xpert Carba-R. This device is classified as a System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen (Class II - Special Controls, product code POC).
Submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on June 29, 2016, 89 days after receiving the submission on April 1, 2016.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1640. To Detect The Presence Of Genetic Markers Of Antimicrobial Resistance By Testing Directly From Clinical Specimens Using Nucleic Acid Amplification Technology..
| 510(k) Number | K160901 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 2016 |
| Decision Date | June 29, 2016 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | POC — System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1640 |
| Definition | To Detect The Presence Of Genetic Markers Of Antimicrobial Resistance By Testing Directly From Clinical Specimens Using Nucleic Acid Amplification Technology. |