# K240041: IVD CAPSULE PSP; abioSCOPE

- Pathway: 510(k) (Traditional)
- Applicant: Abionic SA
- Decided: Sep 25, 2024 after 264 days
- Product code: SCX (Immunoassay For Host Biomarkers Of Sepsis)
- Device class: 2
- Regulation: 21 CFR 866.3215
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN030002 (2003). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070310: B R a H M S PCT Sensitive Kryptor Test System, Brahms Aktiengesellschaft (2008) Summary page 6.

## Indications for use
The IVD CAPSULE PSP is a single-use, rapid in vitro diagnostic immunofluorescence assay for the semi-quantitative determination of the concentration of pancreatic stone protein (PSP) in human K2-EDTA (arterial and venous) and K3-EDTA (venous) anticoagulated whole blood. The IVD CAPSULE PSP is to be used on the abioSCOPE in vitro diagnostic analyzer. This diagnostic test is used in conjunction with other clinical assessments and laboratory findings to aid in the early detection of sepsis manifesting within the first 3 days after testing. IVD CAPSULE PSP generates PSP values that fall within one of three discrete Interpretation bands based on increasing likelihood of sepsis. The test is intended for professional use in clinical laboratory settings. It is indicated for use in adult patients at high risk of sepsis presenting to intensive care units (ICUs).

Source page: https://510kreport.com/device/K240041
Methodology: https://510kreport.com/methodology