K163390 is an FDA 510(k) clearance for the iC-GPC Assay TM for use on the iC-SystemTM. This device is classified as a Gram-positive Bacteria And Their Resistance Markers (Class II - Special Controls, product code PAM).
Submitted by Icubate, Inc. (Huntsville, US). The FDA issued a Cleared decision on August 8, 2017, 249 days after receiving the submission on December 2, 2016.
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 | K163390 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 02, 2016 |
| Decision Date | August 08, 2017 |
| Days to Decision | 249 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. |