K191288 is an FDA 510(k) clearance for the Acuitas AMR Gene Panel. 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 Opgen, Inc. (Rockville, US). The FDA issued a Cleared decision on September 30, 2021, 871 days after receiving the submission on May 13, 2019.
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 | K191288 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 2019 |
| Decision Date | September 30, 2021 |
| Days to Decision | 871 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. |