K173263 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 January 9, 2018, 90 days after receiving the submission on October 11, 2017.
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 | K173263 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 11, 2017 |
| Decision Date | January 09, 2018 |
| Days to Decision | 90 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. |