K240041 is an FDA 510(k) clearance for the IVD CAPSULE PSP. This device is classified as a Immunoassay For Host Biomarkers Of Sepsis (Class II - Special Controls, product code SCX).
Submitted by Abionic SA (Epalinges, CH). The FDA issued a Cleared decision on September 25, 2024, 264 days after receiving the submission on January 5, 2024.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3215. A Semi-quantitative Immunoassay That Measures The Relative Levels Of Host Response Proteins Isolated From Host Blood Or Similar Specimens..
| 510(k) Number | K240041 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 05, 2024 |
| Decision Date | September 25, 2024 |
| Days to Decision | 264 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | SCX - Immunoassay For Host Biomarkers Of Sepsis |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3215 |
| Definition | A Semi-quantitative Immunoassay That Measures The Relative Levels Of Host Response Proteins Isolated From Host Blood Or Similar Specimens. |