K181663 is an FDA 510(k) clearance for the ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel. This device is classified as a Gram-positive Bacteria And Their Resistance Markers (Class II - Special Controls, product code PAM).
Submitted by Genmark Diagnostics, Incorporated (Carlsbad, US). The FDA issued a Cleared decision on December 20, 2018, 178 days after receiving the submission on June 25, 2018.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3365. A Qualitive Multiplexed In Vitro Diagnostic Device To Detect And Identify Gram Positive Bacteria And Resistant Markers In Positive Blood Cultures..
| 510(k) Number | K181663 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 25, 2018 |
| Decision Date | December 20, 2018 |
| Days to Decision | 178 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | PAM - Gram-positive Bacteria And Their Resistance Markers |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3365 |
| Definition | A Qualitive Multiplexed In Vitro Diagnostic Device To Detect And Identify Gram Positive Bacteria And Resistant Markers In Positive Blood Cultures. |