Immunoassay For Host Biomarkers Of Sepsis
An immunoassay for host biomarkers of sepsis is a semi-quantitative immunoassay device that measures the relative levels of host response proteins from blood or similar specimens, intended to aid in the prediction or diagnosis of sepsis by detecting the patient's systemic inflammatory response. It is classified as FDA Class II (510(k) required) under regulation 866.3215 in the Microbiology specialty, with product code SCX. The device is not an implant and does not support life-sustaining functions.
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Basic Information
- Product Code
- SCX
- Device Class
- FDA class 2
- Regulation Number
- 866.3215
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
Definition
A semi-quantitative immunoassay that measures the relative levels of host response proteins isolated from host blood or similar specimens.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K240041 | IVD CAPSULE PSP; abioSCOPE | Sep 25, 2024 | Substantially Equivalent | Abionic SA |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.