BEUDAMED
    Product Code: PVK FDA class 2 21 CFR 862.3910

    Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt

    Clinical Toxicology

    The Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing (Exempt) is a clinical toxicology in vitro diagnostic test for the qualitative analysis of tricyclic antidepressant drugs as a class, designed for employment and insurance drug testing applications. It is classified as FDA Class II under regulation 21 CFR 862.3910 and has been exempted from 510(k) premarket notification requirements by FDA Federal Register publication (82 FR 31976, July 11, 2017), subject to the limitations in 21 CFR 862.9. The product code is PVK and it falls under the Clinical Toxicology medical specialty. It is not flagged as an implant or life-sustaining device.

    View on FDA
    510(k)s
    0
    FEI Numbers
    16
    Registration Numbers
    16
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    PVK
    Device Class
    FDA class 2
    Regulation Number
    862.3910
    Medical Specialty
    Clinical Toxicology
    Review Panel
    TX
    Submission Type
    4

    Device Characteristics

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

    Definition

    The tricyclic antidepressant drugs test is an in vitro diagnostic test for the qualitative analysis of tricyclic antidepressant drugs for employment and insurance testing. FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing.

    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.