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    K Number
    K240041
    Device Name
    IVD CAPSULE PSP; abioSCOPE
    Manufacturer
    Abionic SA
    Date Cleared
    2024-09-25

    (264 days)

    Product Code
    SCX
    Regulation Number
    866.3215
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    K070310
    Why did this record match?
    Device Name :

    IVD CAPSULE PSP; abioSCOPE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended 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 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).

    Device Description

    The IVD CAPSULE PSP is a single-use, semi-quantitative immunofluorescence assay used to determine the concentration of the pancreatic stone protein (PSP) in a human whole blood sample. The test kit contains the following components: Capsule, Special pipette (abioPIPETTE), Vial containing a detection reagent (abioMIX), Desiccant bag. The main component is the capsule, a high impact polystyrene plastic cartridge. The capsule allows dispensing the blood-abioMIX solution onto the loading port with a membrane separator. A second membrane drives the sample by capillary force to nanofluidic biosensors containing a read-out area where PSP is captured by specific antibodies and fluorescently detected. The concentration of captured PSP is proportional to the fluorescence generated by the fluorophore conjugated to the detection antibody. The capsule also contains an RFID tag programmed with biosensor configuration and lot-specific information.

    The abioSCOPE is a tabletop diagnostic device that measures analytes in biological samples using test-specific capsules (IVD CAPSULE). It is operated through a high-resolution touchscreen. It is composed of a fully automated fluorescence microscope and a tray for the IVD CAPSULE. The abioSCOPE uses a laser to excite molecular complexes inside the biosensors, leading to fluorescence emission. The abioSCOPE then calculates the concentration of the analyte.

    AI/ML Overview

    The acceptance criteria and the study proving the device meets these criteria are detailed as follows for the IVD CAPSULE PSP device:

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria provided focus on the clinical performance of the device, specifically its ability to classify patients into sepsis risk categories based on PSP concentrations.

    PSP Concentration Range (ng/ml)Acceptance Criteria (Implied by Likelihood Ratio)Reported Device Performance (Predictive Value)Reported Device Performance (Likelihood Ratio)
    ≥ 300High likelihood of sepsis (Likelihood Ratio > 1.0, specifically indicating strong correlation)70.10%2.49 (95% CI: 1.83-3.38)
    100 - 299Moderately increased risk of sepsis (Likelihood Ratio > 1.0, but lower than highest risk category)55.30%1.32 (95% CI: 1.02-1.70)
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