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510(k) Data Aggregation

    K Number
    K250117
    Device Name
    FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette
    Manufacturer
    Assure Tech LLC
    Date Cleared
    2025-02-13

    (28 days)

    Product Code
    LCX, JHI
    Regulation Number
    862.1155
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FaStep Pregnancy Rapid Test Cassette is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in the early detection of pregnancy. For over-the-counter use. The Fastep HCG Rapid Test Cassette is a rapid visual immunoassay for the qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in the early detection of pregnancy. The test kits are for health care professionals use including professionals at physician's office labs (POLs).
    Device Description
    The FaStep Pregnancy Rapid Test Cassette and the Fastep HCG Rapid Test Cassette are the same device with the first intended for over-the counter use and the second for prescription use. The devices contain individually wrapped pouches containing the device, instructions for use, and pipette droppers. The devices utilize a combination of antibodies to detect hCG in urine as well as to serve as a run control. The result is displayed to the user in the test window as two lines for a 'Pregnant' positive result and one line for a 'Not Pregnant' negative result.
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    K Number
    K242135
    Device Name
    Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream
    Manufacturer
    Nanjing Synthgene Medical Technology Co., Ltd.
    Date Cleared
    2025-01-31

    (193 days)

    Product Code
    LCX
    Regulation Number
    862.1155
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Synthgene Home Test HCG Test Midstream is used for the qualitative detection of human chorionic gonadotropin in urine to aid in the early detection of pregnancy. Synthqene Home Test HCG Test Cassette is used for the qualitative detection of human chorionic gonadotropin in urine to aid in the early detection of pregnancy. Synthqene Home Test HCG Test Strip is used for the qualitative detection of human chorionic gonadotropin in urine to aid in the early detection of pregnancy.
    Device Description
    Synthgene Home Test HCG Test is used for the qualitative detection of human chorionic gonadotropin in urine to aid in the early detection of pregnancy. The test devices are in three different formats: Strip, Cassette and Midstream. Each test kit contains the individually packaged test pen/strip/cassette, medical waste bag, urine cup and instructions for Use. The cassette format also contains a dropper. The device is in a readyto-use format and does not require assembly before use.
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    K Number
    K243573
    Device Name
    FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream
    Manufacturer
    Assure Tech LLC
    Date Cleared
    2025-01-15

    (57 days)

    Product Code
    LCX
    Regulation Number
    862.1155
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FaStep Early Pregnancy Rapid Test Strip is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, (i.e. as early as five (5) days before the day of the expected period). For over thecounter use. FaStep Early Pregnancy Rapid Test Cassette is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, (i.e. as early as five (5) days before the day of the expected period). For over thecounter use. FaStep Early Pregnancy Rapid Test Midstream is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, (i.e. as early as five (5) days before the day of the expected period). For overthe-counter use.
    Device Description
    FaStep Early Pregnancy Rapid Test will be sold in Strip, Cassette and Midstream format. The Strip format is a single test strip. The Cassette format consists of a single test strip assembled in a plastic housing. The Midstream format consists of a single test strip assembled in a plastic housing with an absorbent tip, and is designed to be tested in dip or midstream mode. FaStep Early Pregnancy Rapid Test Strip, FaStep Early Pregnancy Rapid Test Cassette and FaStep Early Pregnancy Rapid Test Midstream each contains a pouch with the device and instructions, and in addition, cassette format is packaged with pipette dropper. The devices utilize a combination of antibodies to detect hCG in urine as well as to serve as a run control. Each device contains mouse monoclonal anti-ß-hCG antibody colloidal gold conjugate pre-dried on the sample pad. Mouse monoclonal anti-a-hCG antibody (on the Test Line) and goat anti mouse IgG polyclonal antibody (on the Control Line) are coated and immobilized on a nitrocellulose membrane. The result is displayed to the user in the test window as two lines for a 'Pregnant' positive result and one line for a 'Not Pregnant' negative result.
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    K Number
    K241394
    Device Name
    iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip
    Manufacturer
    Andon Health Co., Ltd.
    Date Cleared
    2024-12-20

    (218 days)

    Product Code
    LCX
    Regulation Number
    862.1155
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The iHealth® Early Pregnancy Test is an OTC in vitro diagnostic test used to assess early pregnancy by detecting the presence of the hCG (human chorionic gonadotropin) hormone in urine. The test device is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the missed period, i.e., as early as five (5) days before the day of the expected period. The iHealth® Early Pregnancy Test Strip is an OTC in vitro diagnostic test used to assess early pregnancy by detecting the presence of the hCG (human chorionic gonadotropin) hormone in urine. The test device is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the missed period, i.e., as early as five (5) days before the day of the expected period.
    Device Description
    The iHealth® Early Pregnancy Test is a lateral flow immunoassay technique device designed for the qualitative determination of human chorionic gonadotropin (hCG) concentration in human urine samples, and is indicated for use as an aid in early detection of pregnancy. The iHealth® Early Pregnancy Test is designed to detect as early as six (6) days before the day of the missed period, i.e., as early as five (5) days before the day of the expected period. Test result is displayed to the user as two lines for a 'Pregnant' result and one line for a 'Not Pregnant' result. The iHealth® Early Pregnancy Test are in two different formats: Stick and Strip format. Two test formats use identical strips and each test strip in the device consists of: Sample pad, colloidal gold binding pad, nitrocellulose membrane, absorbent paper and PVC board, colloidal gold binding pad coated with hCG monoclonal antibody 1, test line(T Line) coated with hCG-monoclonal antibody 2 and control line(C Line) coated with goat anti-mouse IgG antibody. Two formats have the same performance specifications. The difference is that Stick format is designed to be tested in dip or midstream method, and Strip format is tested in dip method only.
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    K Number
    K240242
    Device Name
    HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold)
    Manufacturer
    Anhui DEEPBLUE Medical Technology Co. LTD.
    Date Cleared
    2024-10-11

    (255 days)

    Product Code
    LCX
    Regulation Number
    862.1155
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HCG Home Use Pregnancy Test Strip (Colloidal Gold) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The test strip is designed for over-the-counter use. Important note regarding positive results: This test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare providers, especially when making decisions about future medical care. This device is intended for home use only. The HCG Home Use Pregnancy Test Cassette (Colloidal Gold) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The test cassette is designed for over-the-counter use. Important note regarding positive results: This test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare providers, especially when making decisions about future medical care. This device is intended for home use only. The HCG Home Use Pregnancy Test Midstream (Colloidal Gold) is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The test midstream is designed for over-the-counter use. Important note regarding positive results: This test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare providers, especially when making decisions about future medical care. This device is intended for home use only.
    Device Description
    The HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold) and HCG Home Use Pregnancy Test Midstream (Colloidal Gold) utilize a combination of antibodies including a monoclonal HCG antibody to selectively detect elevated levels of HCG. The detection method is to observe the formation of colored lines when testing urine samples with test devices. The specimen migrates via capillary action along the membrane to react with the colored conjugate. Positive specimens react with the specific antibody-HCG-colored conjugate and form a red colored line at the test line region of the membrane. The absence of this colored line suggests a negative result. To serve as a procedural control, a colored line will always appear in the control line region if the test has been performed properly. HCG Pregnancy Test will be sold in three different formats: Cassette, Strip, and Midstream. The Test Strip and Midstream format contain a test device sealed in a desiccated aluminum pouch and an Instruction. The Cassette format contains a test device, a dropper, a collection container and an Instruction. The test uses two red lines to indicate results. Two distinct red lines appear in the control region (C) and test region (T) means the test is "positive". Only one red line appears in the control region(C). No apparent line in the test region (T). means the test is "negative". If No coloured line appears in the control region (C), or if there is no color band in control region (C) even there is a band in the test region (T),this means "invalid" test result.
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    K Number
    K241978
    Device Name
    Shinetell Digital Pregnancy Test
    Manufacturer
    Hangzhou AllTest Biotech Co., Ltd.
    Date Cleared
    2024-08-13

    (39 days)

    Product Code
    LCX
    Regulation Number
    862.1155
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ShinetellTM Digital Pregnancy Test is a pregnancy test. It is used for the qualitative detection of hCG in human urine as an aid in early detection of pregnancy. For in vitro diagnostic use, for over the counter use.
    Device Description
    Shinetell™ Digital Pregnancy Test is used for in vitro qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine, and is designed to be tested in dip or midstream mode. The test device consists of a single test strip assembled in a plastic housing, with an absorbent tip. The device is in a ready-to-use format. Shinetell™ Digital Pregnancy Test uses lateral flow immunoassay and light reflection for the detection of the HCG in urine specimens. The test would detect the light intensity by using the LED as the light source. After that, the result can be displayed on the display screen.
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    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
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    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
    K240643
    Device Name
    MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream
    Manufacturer
    Guangzhou Decheng Biotechnology Co., Ltd.
    Date Cleared
    2024-06-21

    (106 days)

    Product Code
    LCX
    Regulation Number
    862.1155
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MissLan® Early Detection Pregnancy Test Strip is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, (i.e. as early as five (5) days before the day of the expected period). It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over-the-counter use. Important note regarding positive results: Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare provider, especially when making decisions about future medical care. This device is intended for home-use only. MissLan® Early Detection Pregnancy Test Cassette is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, (i.e. as early as five (5) days before the day of the expected period). It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over-the-counter use. Important note regarding positive results: Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare provider, especially when making decisions about future medical care. This device is intended for home-use only. MissLan® Early Detection Pregnancy Test Midstream is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, (i.e. as early as five (5) days before the day of the expected period). It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over-the-counter use. Important note regarding positive results: Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare provider, especially when making decisions about future medical care. This device is intended for home-use only.
    Device Description
    MissLan® Early Detection Pregnancy Test will be sold in Strip. Cassette and Midstream format. The Strip format is a single test strip. The Cassette format consists of a single test strip assembled in a plastic housing. The Midstream format consists of a single test strip assembled in a plastic housing with an absorbent tip, and is designed to be tested in dip or midstream mode. MissLan® Early Detection Pregnancy Test Strip. MissLan® Early Detection Pregnancy Test Cassette and MissLan® Early Detection Pregnancy Test Midstream each contains a pouch with the device and instructions, and in addition, cassette format is packaged with pipette dropper and urine collection cup. The devices utilize a combination of antibodies to detect hCG in urine as well as to serve as a run control. Each device contains mouse monoclonal anti-ß-hCG antibody colloidal gold conjugate pre-dried on the sample pad. Mouse monoclonal anti-a-hCG antibody (on the Test Line) and goat anti mouse IgG polyclonal antibody (on the Control Line) are coated and immobilized on a nitrocellulose membrane. The result is displayed to the user in the test window as two lines for a 'Pregnant' positive result and one line for a 'Not Pregnant' negative result.
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    K Number
    K232715
    Device Name
    Distinct® Digital Pregnancy Test
    Manufacturer
    ACON Laboratories, Inc.
    Date Cleared
    2024-05-31

    (269 days)

    Product Code
    LCX
    Regulation Number
    862.1155
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Distinct® Digital Pregnancy Test is an over-the-counter chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. It is intended for use as an aid for the early detection of pregnancy. This test can help determine if you are pregnant as early as 6 days before the day of the missed period (5 days before the day of your expected period).
    Device Description
    Not Found
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    K Number
    K233581
    Device Name
    VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack
    Manufacturer
    Ortho Clinical Diagnostics
    Date Cleared
    2024-05-08

    (183 days)

    Product Code
    DHA
    Regulation Number
    862.1155
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For in vitro diagnostic use only. For the quantitative measurement of human chorionic gonadotropin (hCG) and its ß-subunit in human serum and plasma (heparin and EDTA) using the VITROS 5600 Integrated System to aid in the early detection of pregnancy.
    Device Description
    The VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack (test) is performed using the VITROS Immunodiagnostic Products Total β-hCG II Reagent Pack and VITROS Immunodiagnostic Products Total B-hCG II Calibrators on the VITROS 5600 Integrated System. An immunometric immunoassay technique is used, which involves the reaction of human chorionic gonadotropin (hCG) present in the sample with a microwell coated with biotinylated Antibody (mouse monoclonal anti-ß-hCG) bound to streptavidin, and a Horseradish Peroxidase (HRP)-labelled antibody conjugate (mouse monoclonal anti-ß-hCG). Unbound materials are removed by washing. The bound HRP conjugate is measured by a luminescent reaction. A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent, is added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent (a substituted acetanilide) increases the level of light produced and prolongs its emission. The light signals are read by the system. The amount of HRP conjugate bound is directly proportional to the concentration of hCG present in the sample. VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack contains: 1 reagent pack containing: - 100 coated wells (antibody, mouse monoclonal anti-ß-hCG, binds >600 mIU hCG/well) - 14.4 mL assay reagent (buffer containing mouse serum, bovine serum albumin, bovine gamma globulin and . antimicrobial agent) - 19.2 mL conjugate reagent (HRP-mouse monoclonal anti-β-hCG, binds ≥4005 mIU hCG/mL) in buffer with ● bovine serum albumin and antimicrobial agent. VITROS Total ß-hCG II Calibrators contains: - 3 sets of VITROS Total ß-hCG II Calibrators 1, 2 and 3, (freeze-dried, recombinant hCG in human plasma with antimicrobial agent, reconstitution volume 1.0 mL), nominal values 0; 3,000; 14,000 mIUmL (U/L) - 24 calibrator bar code labels (8 for each calibrator)
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