510(k) K240041
K240041 is an FDA 510(k) premarket notification submitted by Abionic SA for the device "IVD CAPSULE PSP; abioSCOPE". The FDA issued a decision of Substantially Equivalent on September 25, 2024. The device falls under product code SCX (Immunoassay For Host Biomarkers Of Sepsis), a Class II device regulated under 21 CFR 866.3215.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 25, 2024
- Date Received
- January 5, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Immunoassay For Host Biomarkers Of Sepsis
- Device Class
- Class II
- Regulation Number
- 866.3215
- Review Panel
- MI
- Submission Type
A semi-quantitative immunoassay that measures the relative levels of host response proteins isolated from host blood or similar specimens.