BEUDAMED
    Product Code: PTF FDA class 2 21 CFR 866.3215

    Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission

    Microbiology

    The Assay to Measure PCT to Aid in the Risk Assessment of Critically Ill Patients is an in vitro diagnostic device that measures procalcitonin (PCT) to aid in assessing the risk of progression to severe sepsis and septic shock in critically ill patients on their first day of ICU admission. It is classified as FDA Class 2 under 21 CFR 866.3215 in the Microbiology specialty, requiring 510(k) premarket notification. The assay supports early risk stratification to guide clinical management in the ICU. Product code PTF; not an implant and not life-sustaining.

    View on FDA
    510(k)s
    4
    FEI Numbers
    8
    Registration Numbers
    8
    Unique Applicants
    3
    Years Active
    8

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    Basic Information

    Product Code
    PTF
    Device Class
    FDA class 2
    Regulation Number
    866.3215
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    1

    Device Characteristics

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

    Definition

    Assay to measure procalcitonin to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 4 510(k) clearances via K numbers.

    K Number Device Name
    K242294 DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls
    K222996 Access PCT
    K192271 Access PCT, Access PCT Calibrators
    K162297 Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set

    FEI Numbers

    This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.