K191889 is an FDA 510(k) clearance for the NG-Test CARBA 5. This device is classified as a Phenotypic Test Kit, Non-susceptible/elevated Mic Organisms, Cultured Isolates (Class II - Special Controls, product code PTJ).
Submitted by Ng Biotech (Guipry, FR). The FDA issued a Cleared decision on October 2, 2019, 79 days after receiving the submission on July 15, 2019.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1640. Qualitative Detection Of Carbapenemase Enzymes In Pure Colonies Of Enterobacteriaceae And Pseudomonas Aeruginosa That Have Elevated Mic Values To Any Carbapenem.
| 510(k) Number | K191889 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 2019 |
| Decision Date | October 02, 2019 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | PTJ - Phenotypic Test Kit, Non-susceptible/elevated Mic Organisms, Cultured Isolates |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1640 |
| Definition | Qualitative Detection Of Carbapenemase Enzymes In Pure Colonies Of Enterobacteriaceae And Pseudomonas Aeruginosa That Have Elevated Mic Values To Any Carbapenem |