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510(k) Data Aggregation

    K Number
    K041408
    Device Name
    POLYMEDCO OC AUTO MICRO 80 FOB TEST
    Manufacturer
    POLYMEDCO, INC.
    Date Cleared
    2004-10-21

    (147 days)

    Product Code
    OOX,00X
    Regulation Number
    864.6550
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    POLYMEDCO OC AUTO MICRO 80 FOB TEST

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

    The Polymedco OC Auto Micro 80 Analyzer and OC Auto Micro FOB Test are designed to be used together as an immunological test system intended for the qualitative detection of fecal occult blood in feces by professional laboratories. The automated test is useful for the determination of gastrointestinal (GI) bleeding, found in a number of gastrointestinal (GI) disorders, e.g., colitis, polyps, and colorectal cancer.

    The OC Auto Micro FOB Test is recommended for use in

      1. Routine physical examinations
      1. Monitoring for bleeding in patients
      1. Screening for colorectal cancer or gastrointestinal bleeding
    Device Description

    The Polymedco OC Auto Micro 80 Analyzer and OC Auto Micro FOB Test are designed to be used together as an immunological test system intended for the qualitative detection of fecal occult blood in feces by professional laboratories.

    AI/ML Overview

    This document is a 510(k) clearance letter for "The Polymedco OC Auto Micro 80 FOB Test." It describes the intended use of the device but does not contain information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot provide the requested information based on the provided text. The document confirms the device's substantial equivalence to a predicate device and states its indications for use, but it does not detail the technical performance data that would typically be included in a study report.

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