BEUDAMED
    Product Code: PCG FDA class 2 21 CFR 866.5660

    21-Hydroxylase Antibody (21-Ohab)

    Immunology

    The 21-Hydroxylase Antibody (21-OHAb) assay is an immunology in vitro diagnostic device used for the semi-quantitative determination of antibodies to steroid 21-hydroxylase in human serum, which may be used to support the diagnosis of autoimmune adrenal insufficiency (Addison's disease). It falls under the Immunology medical specialty and is classified as a Class 2 device under regulation 866.5660, requiring 510(k) premarket notification. Detection of 21-hydroxylase autoantibodies is a key marker for autoimmune primary adrenal insufficiency. It is not an implant and is not life-sustaining.

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    510(k)s
    2
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    2
    Years Active
    6

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    Basic Information

    Product Code
    PCG
    Device Class
    FDA class 2
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Review Panel
    IM
    Submission Type
    1

    Device Characteristics

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

    Definition

    For semi-quantitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The assay may be useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune Addison's disease (isolated) or Addison's disease as part of more complex autoimmune polyglandular syndrome (APS), type I or II. The assay result is to be used in conjunction with other clinical and laboratory findings and is not a substitute for functional testing required to diagnose adrenal insufficiency.

    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
    K180607 Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit
    K121046 STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT

    FEI Numbers

    This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.