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510(k) Data Aggregation

    K Number
    K030394
    Device Name
    FLUID SAMPLE RETRIEVAL SYSTEM
    Manufacturer
    BIOMED PERSONAL METABOLIC AND NUTRITIONAL TESTING
    Date Cleared
    2003-10-27

    (264 days)

    Product Code
    JKA
    Regulation Number
    862.1675
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Personal Fluid Sample Retrieval System is for over-the-counter distribution and is a device for collection and transportation of serum for in vitro diagnostic quantitative determination of cholesterol, triglycerides, glucose, HDL cholesterol and calculated LDL cholesterol. The serum sample is transferred in a transport pouch to the testing laboratory and results are returned directly to the consumer.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device called "Personal Fluid Sample Retrieval System". It does not contain information about acceptance criteria or specific study details proving a device meets those criteria. The letter primarily states that the device is substantially equivalent to a legally marketed predicate device.

    Therefore, I cannot provide the requested information based on the given text.

    The provided text focuses on the regulatory clearance of a medical device and does not include the detailed technical study information required to answer your questions about acceptance criteria and device performance studies.

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