K152614 is an FDA 510(k) clearance for the Xpert Carba-R. This device is classified as a System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-susceptible Gram Negative Organism, Colony (Class II - Special Controls, product code PMY).
Submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on March 7, 2016, 175 days after receiving the submission on September 14, 2015.
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 Isolated Bacterial Colonies Using Nucleic Acid Amplification Technology..
| 510(k) Number | K152614 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 14, 2015 |
| Decision Date | March 07, 2016 |
| Days to Decision | 175 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | PMY — System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-susceptible Gram Negative Organism, Colony |
| 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 Isolated Bacterial Colonies Using Nucleic Acid Amplification Technology. |