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510(k) Data Aggregation

    K Number
    K241919
    Device Name
    Innovita HCG Pregnancy Rapid Combo Test
    Manufacturer
    Innovita (Tangshan) Biological Technology CO., LTD
    Date Cleared
    2024-08-02

    (32 days)

    Product Code
    JHI
    Regulation Number
    862.1155
    Why did this record match?
    Product Code :

    JHI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Innovita HCG Pregnancy Rapid Combo Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine or serum to aid in the early detection of pregnancy. The test is for health care professionals use including professionals at point of care (POC).
    Device Description
    The Innovita HCG Pregnancy Rapid Combo Test measures the presence of the hormone Human Chorionic Gonadotrophin (HCG) in human urine or serum for the early detection of pregnancy. During pregnancy, HCG is produced by the placenta shortly after the embryo attaches to the uterine lining. The test device is used as a single cassette device.
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    K Number
    K203272
    Device Name
    Alltest Pregnancy Rapid Combo Test Cassette
    Manufacturer
    Hangzhou AllTest Biotech Co., Ltd
    Date Cleared
    2022-01-31

    (451 days)

    Product Code
    JHI
    Regulation Number
    862.1155
    Why did this record match?
    Product Code :

    JHI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Altest Pregnancy Rapid Combo Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin in urine or serum to aid in the early detection of pregnancy. The test is for health care professionals use including professionals at point of care (POC).
    Device Description
    The Alltest Pregnancy Rapid Combo Test Cassette measures the presence of the hormone Human Chorionic Gonadotrophin (HCG) in human urine or serum for the early detection of pregnancy. During pregnancy, HCG is produced by the placenta shortly after the embryo attaches to the uterine lining. The test device is used as a single cassette device.
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    K Number
    K172322
    Device Name
    Atellica IM Total hCG (ThCG)
    Manufacturer
    Siemens Healthcare Diagnostics Inc.
    Date Cleared
    2018-03-29

    (240 days)

    Product Code
    JHI
    Regulation Number
    862.1155
    Why did this record match?
    Product Code :

    JHI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Atellica IM Total hCG (ThCG) assay is for in vitro diagnostic use in the quantitative determination of human chorionic gonadotropin (hCG) in human serum using the Atellica IM Analyzer. The Atellica IM ThCG assay is intended for use as an aid in the early detection of pregnancy.
    Device Description
    The Atellica IM Total hCG (ThCG) assay is an in vitro diagnostic assay for the quantitative determination of human chorionic gonadotropin (hCG) in human serum using the Atellica IM Analyzer. The assay utilizes a sandwich immunoassay principle with direct chemiluminescent technology. The reagents include a Lite Reagent containing goat polyclonal anti-hCG antibody labeled with acridinium ester and a Solid Phase containing mouse monoclonal anti-hCG antibody covalently coupled to paramagnetic particles. Ancillary reagents like Atellica IM ThCG DIL are also part of the system.
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    K Number
    K172257
    Device Name
    TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)
    Manufacturer
    True Diagnostics, Inc
    Date Cleared
    2017-12-22

    (149 days)

    Product Code
    JHI, LCX, VIS
    Regulation Number
    862.1155
    Why did this record match?
    Product Code :

    JHI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TrueDx™ hCG Early Result Pregnancy Test (Midstream & Cassette Formatographic immunoassay for qualitative detection of human chorionic (hCG) in urine, as an in aid in early detection of pregnancy, in some case as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period. VeriClear™ Early Result Pregnancy Test (Midstream & Cassette Formatographic immunoassay for qualitative detection of human chorionic (hCG) in urine, as an in aid in early detection of pregnancy, in some case as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period.
    Device Description
    TrueDX™ hCG Early Result Pregnancy Test is designed to be tested in midstream and cassette mode. Each of the devices (Cassette and Midstream), contains a pouch with the test and instructions for use. The cassette and midstream nitrocellulose test strips are contained in a plastic housing. The cassette test also contains a dropper. TrueDX™ hCG Early Result Pregnancy Test is a qualitative lateral flow immunoassay for the detection of hCG. The device comes in two formats: Cassette and Midstream. Each device includes a pouch with the all components to perform the test, instruction for use and a desiccant package to control the moisture during the storage of the test kit. The cassette and midstream nitrocellulose test strips are mounted in a plastic housing. The cassette test, which is designed to be used as prescription use contains a dropper pipette. The VeriClear™ Early Result Pregnancy Test and TrueDX™ hCG Early Result Pregnancy Test are the same devices, except the device names and intended use population.
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    K Number
    K152768
    Device Name
    Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip
    Manufacturer
    ASSURE TECH. CO., LTD.
    Date Cleared
    2016-02-24

    (153 days)

    Product Code
    JHI
    Regulation Number
    862.1155
    Why did this record match?
    Product Code :

    JHI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette is a rapid visual immunoassay for the qualitative, presumptive detection of human chorionin in human urine or serum specimens. This kit is intended for use as an aid in early detection of pregnancy. This product is intended for prescription use in clinical laboratories and point-of-care use settings. The Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip is a rapid visual immunoassay for the qualitative, presumptive detection of human chorionic gonadotropin in human urine or serum specimens. This kit is intended for use as an aid in early detection of pregnancy. This product is intended for prescription use in clinical laboratories and point-of-care use settings.
    Device Description
    Assure Tech hCG Pregnancy Serum/Urine Combo Test (Cassette, Strip) measures the presence of the hormone Human Chorionic Gonadotrophin (hCG) in human urine or serum for the early detection of pregnancy. During pregnancy, hCG is produced by the placenta shortly after the embryo attaches to the uterine lining. The test devices are in two different formats: Strip, Cassette.
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    K Number
    K130456
    Device Name
    WUNDER PREGNANCY TEST
    Manufacturer
    JAMES NGUYEN
    Date Cleared
    2014-04-08

    (410 days)

    Product Code
    JHI
    Regulation Number
    862.1155
    Why did this record match?
    Product Code :

    JHI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Wunder Pregnancy Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in human urine. The device is visually read as an aid for the early detection of pregnancy and intended for in vitro single use. This test is intended for prescription use including at point-of-care sites.
    Device Description
    Wunder Pregnancy Test is a single-use qualitative immunochromatic lateral flow device intended to detect human chorionic gonadotropin (hCG) in urine to help in the early detection of pregnancy. The device is visually read and intended for prescription use. Wunder Pregnancy Test is provided in a cassette format. A pipette is included for use with the device. The operator utilizes the included pipette to collect a sample of urine specimen to be tested from a sample cup. The operator then dispenses the urine specimen into the round sample well of the device. An absorbent, nitrocellulose membrane strip is incorporated in the sample well into the rectangular window where the results are read. In the results window, there are two band regions on the membrane strip, a test band and a control band. The test band region is pre-coated with Goat anti-a hCG antibodies. Goat anti-β monoclonal antibodies are placed on the membrane between the test band and the sample well. During the test, the urine sample is allowed to migrate upward and hydrate the anti-β monoclonal antibodies. The mixture then migrates along the membrane by capillary action to the immobilized Goat anti-α hCG antibodies in the test band region. In the presence of hCG in the urine, the anti-ß monoclonal antibodies bind with the hCG ß unit antigen and moves with the sample urine fluid by capillary action along the membrane. As the solution reaches the test band, the antibody hCG ß-unit antigen complex becomes linked to the pre-coated Goat anti-a hCG antibodies to form a visible precipitate that can be seen as a color line at the test band. Therefore, the formation of a visible color line on the test band region indicates the urine sample has tested positive for hCG. In the absence of hCG in the urine, the anti-ß monoclonal antibodies bypass the pre-coated Goat anti-q hCG antibodies in the test region without forming a visible precipitate. As a result, the absence of a visible color line in the test band region indicates the urine sample tested is negative for hCG. The distal control band region is pre-coated with Goat anti Mouse IgG. If there is sufficient urine volume, the anti-ß antibodies will migrate by capillary action to the control region. The anti-ß antibodies will bind with the Goat anti Mouse IgG and precipitate to form a color line. This antigen-antibody reaction at the control line ensures that the test is performed properly and should always be seen as a visible line duringtesting. The presence of this color band in the control region serves as verification that sufficient urine volume has been added and that proper flow was obtained. In conclusion, a valid positive urine sample produces two distinct color bands. A valid negative sample produces only one color band in the control zone.
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    K Number
    K132834
    Device Name
    FASTEP S10 HCG SERUM/URINE COMBO TEST
    Manufacturer
    POLYMED THERAPEUTICS, INC
    Date Cleared
    2014-01-09

    (121 days)

    Product Code
    JHI
    Regulation Number
    862.1155
    Why did this record match?
    Product Code :

    JHI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fastep S10 hCG Serum/Urine Combo Test is a rapid visual immunoassay for the qualitative, presumptive detection of human chorionic gonadotropin in human urine or serum specimens. This kit is intended for use as an aid in early detection of pregnancy. This product is only intended for prescription use in clinical laboratories and is not intended for point-of-care use settings.
    Device Description
    Fastep S10 hCG Serum/Urine Combo Test measures the presence of the hormone Human Chorionic Gonadotrophin (HCG) in human urine or serum for the early detection of pregnancy. During pregnancy, HCG is produced by the placenta shortly after the embryo attaches to the uterine lining. The test devices are in two different formats: Strip, Cassette.
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    K Number
    K131166
    Device Name
    SOFIA(R) HCG FIA
    Manufacturer
    QUIDEL CORP.
    Date Cleared
    2013-08-02

    (100 days)

    Product Code
    JHI
    Regulation Number
    862.1155
    Why did this record match?
    Product Code :

    JHI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sofia hCG FIA is an immunofluorescence-based lateral flow assay intended for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine specimens and is designed to aid early detection of pregnancy. The test is intended for prescription use only, including use at point-of-care sites.
    Device Description
    The test kit consists of individually packaged test Cassettes-each containing monoclonal murine antibodies for the capture and detection of hCG; disposable specimen transfer pipettes; and a package insert. The test is a qualitative immunofluorescence-based assay used to detect concentrations of 20 mIU/mL hCG or more in urine.
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    K Number
    K123844
    Device Name
    CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST
    Manufacturer
    CHEMTRON BIOTECH, INC.
    Date Cleared
    2013-05-30

    (168 days)

    Product Code
    JHI
    Regulation Number
    862.1155
    Why did this record match?
    Product Code :

    JHI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Chemtrue® hCG urine or Combo test is a rapid lateral flow immunoassay for the visual qualitative detection of human chorionic gonadotropin (hCG) in human urine or serum as an aid in the early determination of pregnancy. The Dipstick/Cassette and Combo Tests are for prescription use only, including at physician's offices or other Point-Of-Care sites (POC).
    Device Description
    The Chemtrue® hCG urine test is designed in Dipstick and Cassette formats. The hCG Combo (Serum/Urine) test is available in Cassette format only. Each test device consists of one (1) individual test strip and each test strip in the device consists of: 1) A conjugate pad contains colloidal gold conjugated with monoclonal anti-hCG antibody specific to the beta subunit of hCG. 2) A nitrocellulose membrane which is striped with the specific goat anti-hCG in the test line (T line) and goat anti-mouse antibody in the control line (C line serves as an internal quality control of the system and appears as a colored band during the test regardless of the hCG level in the test sample. All the configurations have the same membrane format, reagents and gold conjugate pad, as well as the same flow characteristics, except the test line in the nitrocellulose membrane for hCG Combo test is striped with polyclonal goat anti-hCG antibodies. Devices are packaged one device per foil pouch and 25 devices in each kit.
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    K Number
    K112101
    Device Name
    FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS
    Manufacturer
    POLYMED THERAPEUTICS, INC
    Date Cleared
    2012-07-17

    (361 days)

    Product Code
    JHI, RAD
    Regulation Number
    862.1155
    Why did this record match?
    Product Code :

    JHI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Polymed Therapeutics' Fastep™ hCG Pregnancy Serum/Urine Test is a rapid chromatographic immunoassays for the visual, qualitative detection of human chorionic gonadotropin (hCG) in serum or urine specimen to aid in the early detection of pregnancy. For Professional Use Only. The test kits are for health care professionals use including professionals at physician's office labs (POLs) and Point-of-Care site (POC).
    Device Description
    The Fastep™ hCG Pregnancy Serum/Urine Test are distributed in Cassette format. Each test reagent strip contains mouse monoclonal anti-a-hCG antibody coated membrane and a dried chemical pad containing mouse monoclonal anti-B-hCG anybody colloidal gold conjugate. The control antibodies are goat anti-mouse IgG.
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