BEUDAMED
    Product Code: OPN FDA class 2 21 CFR 866.5660

    Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex

    Immunology

    The Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex device (product code OPN) is a Class 2 immunology in vitro diagnostic regulated under 21 CFR 866.5660 in the Immunology specialty (IM), cleared via 510(k). It is intended for the detection of autoantibodies to phosphatidylserine (PS), prothrombin (PT), or the PS/PT complex in human serum or plasma to aid in the diagnosis of autoimmune thrombotic disorders such as antiphospholipid syndrome and those secondary to systemic lupus erythematosus. The device is eligible for third-party review and is not an implant or life-sustaining device.

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

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    Basic Information

    Product Code
    OPN
    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 the detection of autoantibodies to phosphatidylserine (PS), prothrombin (PT), or phosphatidylserine/prothrombin (PS/PT) complex in human serum or plasma. To aid in the diagnosis of certain autoimmune thrombotic disorders such as anti-phospholipid syndrome and those secondary to systemic lupus erythematosus or other lupus-like diseases

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K090755 QUANTA LITE APS/PT IGG AND IGM ELISA

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.