DeviceClearance

Product code SCX— Microbiology

IVD CAPSULE PSP; abioSCOPE

Classification name
Immunoassay For Host Biomarkers Of Sepsis
Device class
Class 2
Regulation
21 CFR 866.3215
Advisory panel
Microbiology
Total cleared
1
First cleared
Most recent

FDA classification definition

“A semi-quantitative immunoassay that measures the relative levels of host response proteins isolated from host blood or similar specimens.”

— U.S. Food and Drug Administration, device classification record for product code SCX under 21 CFR 866.3215, via openFDA

Market context for product code SCX

FDA has cleared 1 device under product code SCX, all in 2024, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SCX

Recent clearances under product code SCX

Data sourced from openFDA. This site is unofficial and independent of the FDA.