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510(k) Data Aggregation

    K Number
    K243146
    Device Name
    iCare APP
    Manufacturer
    iHealth Labs, Inc.
    Date Cleared
    2025-02-03

    (126 days)

    Product Code
    MWI, DXN, OCH, OUG, PUH
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    iHealth Labs, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The iCare App is intended for use in the home and clinical settings as and their healthcare professionals to view test results which are measured by iHealth devices to better manage user's health and get feedback from their professional care team. The iCare App can also connect to medical devices and or non-medical devices and get data from devices during measurement or from the data stored in memory of the device for enhanced data managements. Data can be transmitted, displayed, and stored in the App.
    Device Description
    The iCare APP is a mobile application on both Android and iOS platforms.iCare allows users to better manage their own health by enabling them to measure their vital signs, access their results and relevant health information with just their smart device and internet connection, and receive feedback from their professional care team. iCare includes a patient darshboard featuring the Home, Health, Plus, Education, and Profile tabs. Accessory devices can be connected to the system to allow for collection of blood sugar, blood pressure, blood oxygen, and/or weight measurements. The patient darshboard functionality includes the ability to start measuring, allows users to view and track measurements, and export testing schedules for blood sugar, blood pressure, blood oxygen, and weight measurements; send messages to their professional care team; view previous appointment history information; view medication instructions; add entries to the food diary and review feedback from their registered dietician; set timers; and access articles and videos about health knowledge.
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    K Number
    K233842
    Device Name
    iHealth COVID-19 Antigen Rapid Test
    Manufacturer
    iHealth Labs, Inc
    Date Cleared
    2024-05-31

    (179 days)

    Product Code
    QYT
    Regulation Number
    866.3984
    Why did this record match?
    Applicant Name (Manufacturer) :

    iHealth Labs, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The iHealth COVID-19 Antigen Rapid Test is a visually read lateral flow immunoassay device intended for the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen directly in anterior nasal swab specimens from individuals with signs and symptoms of COVID-19 within the first 6 days of symptom onset. This test is for nonprescription home use by individuals aged 15 years or older testing themselves, or adults testing individuals aged 2 years or older. The iHealth COVID-19 Antigen Rapid Test does not differentiate between SARS-CoV-2. All negative results are presumptive. Symptomatic individuals with an initial negative test result must be re-tested once between 48 and 72 hours after the first test using either an antigen test or a molecular test for SARS-CoV-2. Negative results do not preclude SARS-CoV-2 infections or other pathogens and should not be used as for treatment. Positive results do not rule out co-infection with other respiratory pathogens. This test is not a substitute for visits to a healthcare provider or appropriate follow-up and should not be used to determine any treatments without provider supervision. Individuals who test negative and experience continued or worsening COVID-19 like symptoms, such as fever, cough and/or shortness of breath, should seek follow up care from their healthcare provider. The performance characteristics for SARS-CoV-2 were established from October 2022 to June 2023 when the COVID-19 variant Omicron was dominant. Test accuracy may change as new SARS-CoV-2 viruses emerge. Additional testing with a lab-based molecular test (e.g., PCR) should be considered in situations where a new virus or variant is suspected.
    Device Description
    The iHealth COVID-19 Antigen Rapid Test employs lateral flow immunoassay technology. Using this test allows for the rapid detection of nucleocapsid protein from SARS-CoV-2. To begin the test, a self-collected anterior nares swab sample in individuals aged 15 and older or individuals between the age of 2 to 14 with a swab collected by a parent or quardian is inserted into a tube that has been pre-filled with reagent. The reagent in the tube interacts with the specimen and facilitates exposure of the appropriate viral antigens to the antibodies used in the test. The liguid in the tube, now containing the specimen, is added to the Sample Port of the COVID-19 Test Card. If the extracted specimen contains SARS-CoV-2 antigens, a pink-to-purple T Line, along with a pink-to-purple C Line will appear on the COVID-19 Test Card indicating a positive result. If SARS-CoV-2 antigens are not present at very low levels, only a pinkto-purple C Line will appear.
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