BEUDAMED
    Product Code: OOX FDA class 2 21 CFR 864.6550

    Automated Occult Blood Analyzer

    Hematology

    The Automated Occult Blood Analyzer (product code OOX) is a Class 2 hematology device regulated under 21 CFR 864.6550 in the Hematology specialty (HE), cleared via 510(k). It is an automated test system intended for the qualitative detection of fecal occult blood in feces by professional laboratories, used for the determination of gastrointestinal bleeding as part of colorectal cancer screening or GI evaluation. The device is eligible for third-party review and is not an implant or life-sustaining device.

    View on FDA
    510(k)s
    6
    FEI Numbers
    16
    Registration Numbers
    16
    Unique Applicants
    6
    Years Active
    18

    Basic Information

    Product Code
    OOX
    Device Class
    FDA class 2
    Regulation Number
    864.6550
    Medical Specialty
    Hematology
    Review Panel
    HE
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    The automated test system is intended for the qualitative detection of fecal occult blood in feces by professional laboratories. The automated test is used for the determination of gastrointestinal bleeding.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 6 510(k) clearances via K numbers.

    K Number Device Name
    K200754 Hemosure Accu-Reader A100
    K191147 OC-Auto SENSOR io iFOB Test
    K163225 AFIAS iFOB with AFIAS-50
    K132167 I-CHROMA IFOB WITH I-CHROMA READER
    K092330 OC-SENSOR DIANA IFOB TEST
    K041408 POLYMEDCO OC AUTO MICRO 80 FOB TEST

    FEI Numbers

    This FDA classification entry is associated with 16 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 16 registration numbers. Click on an entry to view related FDA registrations.