BEUDAMED
    Product Code: SCA FDA class 2 21 CFR 866.3987

    Multi-Analyte Respiratory Virus Antigen Detection Test

    Microbiology

    A multi-analyte respiratory virus antigen detection test is a point-of-care in vitro diagnostic device intended for the detection and/or differentiation of multiple respiratory viruses directly from respiratory clinical specimens at the site of sample collection, without requiring sample storage or transport. It is classified as FDA Class II (510(k) required) under regulation 866.3987 in the Microbiology specialty, with product code SCA. The device is not an implant and does not support life-sustaining functions.

    View on FDA
    510(k)s
    11
    FEI Numbers
    22
    Registration Numbers
    22
    Unique Applicants
    8
    Years Active
    1

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    Basic Information

    Product Code
    SCA
    Device Class
    FDA class 2
    Regulation Number
    866.3987
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    1

    Device Characteristics

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

    Definition

    A multi-analyte respiratory virus antigen detection test is an in vitro diagnostic device intended for the detection and/or differentiation of respiratory viruses directly from respiratory clinical specimens. The device is intended to be performed at the site of sample collection, does not involve sample storage and/or transport.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 11 510(k) clearances via K numbers.

    K Number Device Name
    K251092 iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro
    K251085 iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro
    K251538 Status™ COVID-19/Flu A&B
    K251749 Flowflex Plus RSV + Flu A/B + COVID Home Test
    K251604 CareSuperb COVID-19/Flu A&B Antigen Combo Home Test
    K251563 WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test
    K243561 Nano-Check Influenza+COVID-19 Dual Test
    K250377 Flowflex Plus COVID-19 + Flu A/B Home Test
    K243256 WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest
    K243262 QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test
    DEN240029 Healgen Rapid Check COVID-19/Flu A&B Antigen Test

    FEI Numbers

    This FDA classification entry is associated with 22 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 22 registration numbers. Click on an entry to view related FDA registrations.