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510(k) Data Aggregation

    K Number
    K041665
    Device Name
    L1-PRO SYSTEM
    Manufacturer
    PELIKAN TECHNOLOGIES, INC
    Date Cleared
    2004-07-23

    (35 days)

    Product Code
    FMK
    Regulation Number
    878.4850
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The L1-Pro System is an automatic blood lancet device for multi-patient clinical use by a healthcare professional to obtain a capillary blood sample.

    Device Description

    The L1-Pro System is a handheld, battery powered electronic lancing system used by a healthcare professional to obtain capillary blood samples in multi-patient clinical use. It consists of three major components, a reusable lancing control unit called the launcher, a disposable lancet disk with multiple sterile lancets, and disposable sterile isolation strips.

    AI/ML Overview

    The provided text describes the 510(k) summary for the Pelikan Technologies L1-Pro System, a blood lancet device. However, it does not contain the specific performance data, acceptance criteria, or details of the study requested in the prompt. The document states:

    "Testing performed under the Design Control Process verified that the L I -Pro System performed according to specifications and is in compliance with all applicable performance standards."

    This is a general statement and does not provide the detailed information requested. Therefore, I cannot construct the table or answer the specific questions about sample size, ground truth, experts, adjudication, or comparative effectiveness from the provided text.

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