BEUDAMED
    Product Code: QUU FDA class 2 21 CFR 866.3046

    Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples

    Microbiology

    The Simple In Vitro Diagnostic Device for Detection of Secreted Proteins from Bacillus spp. in Human Clinical Samples is a prescription diagnostic device used to detect and presumptively identify Bacillus anthracis and other Bacillus species in human clinical samples, aiding in the diagnosis of anthrax (cutaneous, inhalational, or gastrointestinal) and other Bacillus-caused diseases in individuals with signs of exposure. The device is designed for simple use without sample manipulation or complex analytical steps. Classified as FDA Class 2 under regulation 866.3046, it requires 510(k) clearance in the Microbiology specialty. The device is not an implant and not life-sustaining.

    View on FDA
    510(k)s
    2
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    2
    Years Active
    1

    Basic Information

    Product Code
    QUU
    Device Class
    FDA class 2
    Regulation Number
    866.3046
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    1

    Device Characteristics

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

    Definition

    A simple in vitro diagnostic device for the detection of secreted proteins from Bacillus species (spp.) is a prescription in vitro diagnostic device used to detect and presumptively identify B. anthracis and other Bacillus spp. in human clinical samples as an aid in the diagnosis of anthrax and other diseases caused by Bacillus spp. This device is simple to use and does not involve sample manipulation or measurement of an analyte that could be affected by conditions such as sample turbidity or cell lysis. This device may be used to aid in the presumptive diagnosis of anthrax in individuals who have signs and symptoms consistent with anthrax and a likelihood of exposure. Bacillus infections include anthrax (cutaneous, inhalational, or gastrointestinal) caused by B. anthracis, gastrointestinal disease, non-gastrointestinal infections, and an anthrax-like illness caused by B. cereus.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 2 510(k) clearances via K numbers.

    K Number Device Name
    K232545 The SensiTox B. anthracis Toxin Test
    DEN220044 Active Anthrax DetectTM Plus Rapid Test

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.