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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.

QwikCheck™ Test Strips are for in vitro diagnostic use for the determination of pH and leukocytes (WBCs) in semen. Test results are determined by comparing the color of the test patches to the color chart provided on the bottle label. The test is for professional use only.

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