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For Over-the-Counter Setting: The LensHooke® X3 PRO SE Semen Quality Analyzer used with LensHooke® Semen Test Cassette is an optical device for human semen analysis which provides direct and calculated quantitative measurements for: 1. Sperm concentration (M/mL) 2. Total motility (PR+NP, %) - Progressive motility (%) - Non-Progressive motility (%) - Immotility (%) 3. Sperm morphology (normal forms, %) 4. pH value The LensHooke® X3 PRO SE Semen Quality Analyzer does not provide a comprehensive evaluation of a male's fertility status. It is a self-testing diagnostic system intended for human semen analysis of individuals at home to evaluate male fertility. For Point-of-Care Professional Setting: The LensHooke® X3 PRO Semen Quality Analyzer used with LensHooke® Semen Test Cassette is an optical device for human semen analysis which provides direct and calculated quantitative measurements for: 1. Sperm concentration (M/mL) 2. Total motility (PR+NP, %) - Progressive motility (%) - Non-Progressive motility (%) - Immotility (%) 3. Sperm morphology (normal forms, %) 4. pH value The LensHooke® X3 PRO Semen Quality Analyzer does not provide a comprehensive evaluation of a male's fertility status. It is an in-vitro diagnostic system intended for human semen analysis of individuals in healthcare professional setting to evaluate male fertility.

Semen Quality Analyzer integrates optical design and image analysis and combined with artificial intelligence image processing method, to fully automated analysis of semen quality including sperm pH, semen concentration, motility, and morphology. The images are captured and recorded by cameras and with image processing methods, the locations of sperms are detected. The sperm concentration is analyzed by the sperm unit density; the sperm motility is calculated by tracing sperm trajectories and the sperm morphology is calculated by comparing head and tail percentage. Through camera, the chromatographic image of pH is captured and with image saturation and brightness analysis, the level of pH is determined.

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The SQA-iOw Sperm Quality Analyzer is an automated analyzer intended for in-vitro diagnostic use to determine the following parameters in semen: Measured parameters: - Sperm Concentration/ Total Sperm Concentration, millions/mL - Motile Sperm Concentration (MSC), millions/mL - Progressively Motile Sperm Concentration (PMSC), millions/mL (combines Rapidly and Slowly Progressive Motile Sperm Concentration, millions/mL) - Normal Forms (% Normal Morphology), % Derived parameters: - Total Motility / Total Motile (PR + NP), % - Progressive Motility (PR), % (combines Rapidly and Slowly Progressive, %) - Non-Progressive (NP), % - Immotile (IM), % The SQA-iOw is intended for CLIA Waived settings. The SQA-iOw does not provide a comprehensive evaluation of a male's fertility status and is intended for in vitro use only.

The SQA-iOw Sperm Quality Analyzer is a PC-based analytical medical device that tests human semen samples. The device works with a computer application that manages the device, and information related to the patient, the sample, the test results and the facility. After collection and preparation, 0.6 mL of semen sample is aspirated into a disposable SQA capillary sample delivery system and inserted into the SQA-iOw measurement chamber. The testing process takes approximately 75 seconds. The system performs an automatic self-test and auto-calibration upon start up, and checks device stability before each sample is run. The SQA-iOw Sperm Quality Analyzer utilizes proprietary software code to both perform analysis of semen parameters and present those results on the user interface. This software is installed on a PC as a cloud-based application ("app") and is designed to perform all functions and features of the SQA-iO device, controlled by the user through a proprietary graphical user interface (GUI). The SQA-iOw Sperm Quality Analyzer software analyzes semen parameters using signal processing technology. Sample testing is performed by capturing electrical signals as sperm moves through a light source in the SQA-iO optical block. These light disturbances are converted into electrical signals which are then analyzed by the SQA-iOw software. The SQA-iOw software applies proprietary algorithms to interpret and express these electrical signals and report them as various semen parameters. The SQA-iOw Sperm Quality Analyzer package provides the SQA-iOw device and USB cable. SQA disposable capillaries, cleaning kits and related testing supplies and test kits are supplied individually.

The YO Home Sperm Test (YO 3.0) is a smartphone-based test for semen analysis performed by lay users. The parameters reported by the YO Home Sperm Test (YO 3.0) are: 1. Total Sperm Concentration / Sperm Concentration, M/mL 2. Total Motile / Motility (PR + Non Progressive [NP]), % 3. Progressive Motility (PR), % (combines Rapidly and Slowly Progressive, %) 4. Motile Sperm Concentration (MSC), M/mL 5. Progressively Motile Sperm Concentration (PMSC), M/mL (combines Rapidly and Slowly Motile Sperm Concentration, M/mL) The YO Home Sperm Test (YO 3.0) does not provide a comprehensive evaluation of a male's fertility status and is intended for in vitro, over the counter only.

The YO Home Sperm Test (YO 3.0) is a smartphone-based test for semen analysis performed by lay users. The parameters reported by the YO Home Sperm Test (YO 3.0) are: - 1. Total Sperm Concentration / Sperm Concentration, M/mL - 2. Total Motile / Motility (PR + NP), % - 3. Progressive Motility (PR), % (combines Rapidly and Slowly Progressive, %) - 4. Motile Sperm Concentration (MSC), M/mL - 5. Proqressively Motile Sperm Concentration (PMSC), M/mL (combines Rapidly and Slowly Motile Sperm Concentration, M/mL) The YO Home Sperm Test (YO 3.0) utilizes proprietary algorithms to both conduct semen analysis, and present and store the results and videos on the user's smartphone and in the YO application ("app") is downloaded onto the user's own smartphone (iPhone/Android) and is controlled by the user through a proprietary graphical interface (GUI). The GUI quides the user through the process step by step on the App's screen and operates with the YO device. The YO kit provides the supplies necessary to test up to six semen collection cups, pipettes for sample aspiration, fixed coverslip slides, liquefaction powder and a YO device that connects via WiFi to a smartphone and houses the YO slide. The YO software app guides the user through the sample preparation and testing process step-by-step with mandatory confirmation by the user of each completed step. The app also operates the YO device's camera and processor to provide a semen video. The plastic YO device contains a fixed coverslip slide insertion channel, magnification lens, lens holder, WiFi camera and an LED that lights up the optical path. The YO software captures a video in HD (high definition) mode and implements a unique software algorithm to identify sperm and analyze the light fluctuations resulting from sperm movement to report semen values. The algorithm recognizes when the YO autofocus function has the best image and then defines the optimal area of the video for analysis. When YO reports any semen value below the cut-off for normal, YO recommends performing an additional test with a new sample and to seek medical advice. YO cut-offs are based on WHO 6th ed. reference values for semen parameters, statistical modeling, and expert publications. The user is not required to perform any interpretation of the test results and YO does not review, verify, or interpret the video provided to the operator. The user can only observe and archive his test results and sperm video. YO does not provide a comprehensive evaluation of a male's fertility status and is intended for over-thecounter ), for in vitro use only. The YO software quides the user through the testing process step by step on the smartphone's screen and operates in conjunction with the: YO device, smartphone's built-in camera, flash, and man-machine interface to report and store the results of 5 sperm parameters and a video of the user's semen samples. After analyzing the operator's semen video, the YO software reports both the quantitative results and an explanation about the 5 Semen parameters which are visually presented in the YO app directly following testing. In addition, the operator's sperm video is also presented in the test results section directly following the testing phase of the app.

The SQA-iO Sperm Quality Analyzer is an automated point-of-care in vitro use only medical device for semen analysis performed by healthcare professionals (trained lab technicians). The SQA-iO does not provide a comprehensive evaluation of a male's fertility status. The SQA-iO provides direct and calculated quantitative measurements for the following parameters: Directly measured parameters: - Sperm Concentration, M/mL ● - . Motile Sperm Concentration (MSC), M/mL - . Progressively Motile Sperm Concentration (PMSC), M/mL (combines Rapid and Slow PMSC, millions/mL) - . Normal Forms (Normal Morphology), % Calculated parameters: - Total Motility (PR + NP), % - . Progressive Motility (PR), % (combines Rapidly and Slowly Progressive Motility, %) - Non-Progressive Motility (NP), % . - Immotile (IM), % - Functional Sperm Concentration (FSC), millions/mL ●

The SQA-iO is a PC-based analytical medical device that tests human semen samples. The device works with a computer application that manages the device, and information related to the patient, the sample, test results and the facility. After collection and preparation, 0.6 mL of semen sample is aspirated into a disposable SQA capillary sample delivery system and inserted into the SQA-iO measurement chamber. The testing process takes approximately 75 seconds. The system performs an automatic self-test and auto-calibration upon start up, and checks device stability before each sample is run. The SQA-iO utilizes proprietary software code to both perform analysis of semen parameters and to present those results on the user interface. This software is installed on the user's PC as a cloud-based application ("app") and is designed to perform all functions and features of the SQA-iO device, controlled by the user through a proprietary graphical interface (GUI). The SQA-iO software analyzes semen parameters using signal processing technology. Sample testing is performed by capturing electrical signals as sperm moves through a light source in the SQA-iO optical block. These light disturbances are converted into electrical signals which are then analyzed by the SQA-iO software. The SQA-iO software applies proprietary algorithms to interpret and express these electrical signals and report them as various semen parameters. The SQA-iO package provides all the supplies necessary to perform semen analysis: SQA-iO device, USB cable, SQA disposable capillaries, and a cleaning kit.

The LensHooke X1 PRO Semen Quality Analyzer used with LensHooke Semen Test Cassette is an optical device for human semen analysis which provides direct and calculated quantitative measurements for: (1) Sperm concentration (10^6 per ml) (2) Total motility (PR+NP, %) - Progressive motility (%) - Non-Progressive motility (%) (3) Sperm morphology (normal forms, %) (4) pH value The LensHooke X1 PRO Semen Quality Analyzer does not provide a comprehensive evaluation of a male's fertility status. It is an in-vitro diagnostic system intended for human semen analysis of individuals in healthcare professional setting to evaluate male fertility. The LensHooke X1 PRO SE Semen Quality Analyzer used with LensHooke Semen Test Cassette is an optical device for human semen analysis which provides direct and calculated quantitative measurements for: -Sperm concentration (10^6 per ml) -Total motility (PR+NP, %) -Sperm morphology (normal forms, %) -pH value The LensHooke X1 PRO SE Semen Quality Analyzer does not provide a comprehensive evaluation of a male's fertility status. It is a seff-testing, in-vitro diagnostic system intended for human semen analysis of individuals at home to evaluate male fertility. The systems are intended for single person use only and should not be shared.

Semen Quality Analyzer integrates optical design and image analysis and combined with artificial intelligence image processing method, to fully automated analysis of semen quality including semen pH, sperm concentration and motility. The images are captured and recorded by cameras and with image processing methods, the locations of sperms are detected. The sperm concentration is analyzed by the sperm unit density; the sperm motility is calculated by tracing sperm trajectories and the sperm morphology is calculated by comparing head and tail percentage. Through camera, the chromatographic image of pH is captured and with image saturation and brightness analysis, the level of pH is determined.

The SwimCount™ Sperm Quality Test is a qualitative test that detects sperm concentration above or below 5,000,000 Progressive Motile Sperm Cells per mL (PMSCs/mL). The test is intended for use as an aid in the determination of a man's fertility status. For in vitro, over-the-counter use. The number of progressively motile sperm cells is only one factor that contributes to a male's fertility status. The SwimCount™ Sperm Quality Test does not provide a complete evaluation of a male's fertility status. For a comprehensive assessment of male fertility status then the patient should consult a physician.

The SwimCount™ Sperm Quality Test is intended for in vitro, over-the-counter, use and is a prescreening sperm quality test that measures the number of Progressive Motile Sperm Cells per mL (PMSCs/mL) . The SwimCount™ Sperm Quality Test is a qualitative test that detects sperm concentration above or below 5,000,000 Progressive Motile Sperm Cells per mL (PMSCs/mL). The SwimCount™ Sperm Quality Test cut-off value is derived from the WHO laboratory manual for the Examination and processing of human semen, 5th edition guidelines 2010. The SwimCount™ Sperm Quality Test Kit includes the following components: - SwimCount™ Sperm Quality Test Box ● - SwimCount™ Sperm Quality Test Device ● - Semen Collection Cup (used to collect the sperm sample is to remain in the sample cup for 30 minutes) - . Semen Transfer Pipette (syringe) (used to stir the semen sample 10 times before adding the sample to the Device and further used to collect 0.5 mL semen sample from the sperm sample placed in the cup) - SwimCount™ Sperm Quality Test Instructions for Use .

LensHooke X1 Semen Quality Analyzer for OTC use The LensHooke X1 Semen Quality Analyzer used with LensHooke Semen is an optical device for human semen analysis which provides direct and calculated quantitative measurements for: -Sperm concentration (10^6 per ml) -Total motility (PR+NP, %) -Sperm morphology (normal forms, %) -pH value The LensHooke X1 Semen Quality Analyzer does not provide a comprehensive evaluation of a male's fertility status. It is a self-testing, in-vitro diagnostic system intended for human semen analysis of individuals at home to evaluate male fertility. The systems are intended for single person use only and should not be shared. LensHooke X1 PRO Semen Quality Analyzer for prescription use The LensHooke X1 PRO Semen Quality Analyzer used with LensHooke Semen Test Cassette is an optical device for human semen analysis which provides direct and calculated quantitative measurements for: (1) Sperm concentration (10^6 per ml) (2) Total motility (PR+NP, %) - Progressive motility (%) - Non-Progressive motility (%) - (3) Sperm morphology (normal forms, %) (4) pH value The LensHooke X1 PRO Semen Quality Analyzer does not provide a comprehensive evaluation of a male's fertility status. It is an in-vitro diagnostic system intended for human semen analysis of individuals in healthcare professional setting to evaluate male fertility.

Semen Quality Analyzer integrates optical design and image analysis and combined with artificial intelligence image processing method, to fully automated analysis of semen quality including semen pH, sperm concentration and motility. The images are captured and recorded by cameras and with image processing methods, the locations of sperms are detected. The sperm concentration is analyzed by the sperm unit density; the sperm motility is calculated by tracing sperm trajectories and the sperm morphology is calculated by comparing head and tail percentage. Through camera, the chromatographic image of pH is captured and with image saturation and brightness analysis, the level of pH is determined.

The Trak® Male Fertility Testing System is intended for semi-quantitative assessment of sperm concentration at 15 million sperm per milliliter (M/mL) or below, between 15 and 55 M/mL, and above 55 M/mL. It also provides a qualitative assessment of semen volume. Sperm concentration and semen volume are only two factors that could impact a man's fertility status and time to pregnancy. For complete assessment of male reproductive health, the user should consult a physician. For in vitro, over the counter home use.

The revised Trak® Male Fertility Testing System (Trak) includes a small instrument (the Engine), disposable units in which liquefied semen sample is introduced and the result is interpreted (the Props), and consumables, including Volume Cups and sample droppers. The Volume Cups are used collect, liquefy, and assess the volume of the semen sample. Markings on the Volume Cup allow the interpretation of volume at/below or above the 1.5 mL threshold. The Trak Engine and Props allow for the semi-quantitative assessments of total sperm concentration: below 15 million/mL, between 15 and 55 million/mL, and above 55 million/mL. Trak uses the principle of density gradient separation to isolate sperm cells from human semen to provide an estimation of sperm concentration. The Trak Engine spins a test Prop to compact sperm cells within an introduced semen sample into a visible column (or "pellet"). The Prop gives a defined shape to the column, the height of which corresponds to the concentration of sperm cells in the sample. Since semen may also contain cell debris, immature sperm cells, and other contaminant particulates that could contribute to the apparent size of a pellet, it is necessary to filter out the contaminants. Trak achieves this filtering by removing contaminants from view based on density across a predefined liquid density medium. During operation, approximately 0.17 mL of semen is metered by centrifugal action from the sample inlet into the metering chamber of the Prop. During rotation, the semen floats on "top" of the pre-loaded density medium. Sperm cells pass through the medium due to their high density while contaminants remain floating on the medium. When the spin sequence is complete, the sperm cells form a visible column that is displayed to the user for interpretation. Contaminants that are less dense than the liquid density medium are suspended "above" the medium, substantially separated from the sperm cells and are generally too diffuse to visualize.

The YO™ Home Sperm Test is a smartphone based home test which provides a qualitative assessment of motile sperm concentration (MSC) in human semen. MSC is one aspect of a male semen examination. The YO™ Home Sperm Test does not provide a comprehensive evaluation of a male's fertility status and is intended for over-the-counter, in vitro use only.

YO™ is an over-the-counter device that provides a qualitative assessment of motile sperm concentration (MSC) in human semen. Results are reported as "LOW MSC RANGE" or "MODERATE/NORMAL MSC RANGE," requiring no user interpretation. The YO™ software application is downloaded onto the users' own smartphone and on-screen menus and instructions are shown on the phone's display so that the user is taken through the process step by step. The YO™ kit (purchased on the website) provides all the supplies necessary to evaluate two semen samples: two semen collection cups, two vials of liquefying powder (chymotrypsin), two pipettes for sample aspiration, two fixed coverslip slides for sample testing, one QC slide, and one YOT™ Clip that attaches to the smartphone and houses the fixed coverslip slide.