K182619 is an FDA 510(k) clearance for the ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel. This device is classified as a Gram-negative Bacteria And Associated Resistance Markers (Class II - Special Controls, product code PEN).
Submitted by Genmark Diagnostics, Incorporated (Carlsbad, US). The FDA issued a Cleared decision on April 12, 2019, 200 days after receiving the submission on September 24, 2018.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3365. A Qualitative Multiplexed In Vitro Diagnostic Device To Detect And Identify Gram-negative Bacteria And Resistance Markers In Positive Blood Cultures..
| 510(k) Number | K182619 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 2018 |
| Decision Date | April 12, 2019 |
| Days to Decision | 200 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | PEN - Gram-negative Bacteria And Associated Resistance Markers |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3365 |
| Definition | A Qualitative Multiplexed In Vitro Diagnostic Device To Detect And Identify Gram-negative Bacteria And Resistance Markers In Positive Blood Cultures. |