K243490 is an FDA 510(k) clearance for the LIAISON PLEX Gram-Positive Blood Culture Assay. This device is classified as a Gram-positive Bacteria And Their Resistance Markers (Class II - Special Controls, product code PAM).
Submitted by Luminex Corporation (Northbrook, US). The FDA issued a Cleared decision on June 6, 2025, 206 days after receiving the submission on November 12, 2024.
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 | K243490 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 12, 2024 |
| Decision Date | June 06, 2025 |
| Days to Decision | 206 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. |