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AUTION EYE AI-4510 Urine Particle Analysis System is a fully automated urine particle analyzer for in vitro diagnostic use. AUTION EYE AI-4510 is intended for the quantitative measurement of red blood cells (WBC) and squamous epithelial cells (SQEC), the semi-quantitative measurement of bacteria (BACT) and crystals (CRYS) and the qualitative measurement of white blood cell clumps (WBCC), non-squamous epithelial cells (NSE), hyaline casts (HYAL), non-hyaline casts (NHC), yeast (YST), mucus (MUCS) and sperm (SPRM) in urine samples. A trained operator can set criteria for flagging speciment analyte image decisions should be reviewed and reclassified as necessary by a trained technologist. The AUTION EYE AI-4510 analyzer can be used as a standalone unit or combined with an AUTION MAX AX-4060 urine chemistry analyzer.

The AI-4510 System (AUTION EYE AI-4510) is a fully automated urine particle analyzer for in vitro diagnostic use that uses flow cell digital imaging technology in a clinical laboratory setting. Based on images captured in the flow method, the instrument automatically classifies the images of various formed elements. The AI-4510 System can quantitatively measure RBC, WBC, and SQEC; semi-quantitatively measure BACT, and CRYS; and qualitatively measure WBCC, NSE, HYAL, NHC, YST, MUCS and SPRM in urine samples. In addition, the AI-4510 System allows trained operators to manually review and reclassify all the element images collected by the system.

The UC-1800 Automatic Urine Analyzer is automated instrument which is intended for professional, in vitro diagnostic use only. Depending on the reagent strips being used, the instruments perform semi-quantitative detection of the following analytes in urine: ascorbic acid, microalbumin, leukocytes, creatinine, ketone, urobilinogen, bilirubin, glucose, protein, specific gravity, blood and pH in urine and for qualitative determination of nitrite in urine hydrometer (optional) can determine the color and turbidity of urine. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria. The URIT 11FA urine reagent strips provide semi-quantitative tests for ascorbic acid, leukocytes, setone, urobilinogen, bilirubin, glucose, protein, specific gravity, blood and pH in urine and for qualitative determination of nitrite in urine. The URIT 11FA urine reagent strips are for use with the UC-1800 Automatic Urine Analyzer and are for professional, in vitro diagnostic use only. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria. The URIT 12FA urine reagent strips provide semi-quantitative tests for microalbumin, leukocytes, creatinine, ketone, urobilinogen, bilirubin, glucose, protein, specific gravity, blood and pH in urine and for qualitative determination of nitrite in urine. The URIT 12FA urine reagent strips are for use with the UC-1800 Automatic Urine Analyzer and are for professional, in vitro diagnostic use only. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria.

UC-1800 Automatic Urine Analyzer is characterized by fully automated and simple operation. All you need to do is to set test strips and samples, press the START key, and the rest of operations are fully automated with UC-1800, which can measure samples continuously. For each measurement, the instrument automatically performs a series of operation: sample transmitting, sample aspirating, sample dropping, rinsing strip feeding and color identifying, etc. The instrument is used in conjunction with a serial of URIT urine test strips for measuring 15 parameters. Measure results are printed through either built-in printer or external printer. Urine Reagent Strips is used to determine the components to be measured in urine by dry chemistry method together with urine analyzer. Various components to be tested in the urine can result in changes to the colors of corresponding reagent blocks on the Urine Reagent Strips. The depth of reaction color is proportional to the corresponding component to be tested in the urine. Qualitative and semi-quantitative detection can be conducted to the contents of the corresponding detected components. As a reagent for the determination of multiple components in human urine and the most basic test item for clinical urine routine test), it is suitable for the screening test or auxiliary diagnosis for clinical diagnosis, without the specificity for diseases or indications, and urine dry chemistry test is a screening test and cannot be used as a single diagnostic method.

The Minuteful - kidney test is an in-vitro diagnostic, home-use urine analysis test system for the semi-quantitative measurement of albumin and creatinine in urine, as well as the presentation of their ratio, the albumin-creatinine ratio (ACR). The system consists of a smartphone application, proprietary Color-Board and an ACR Reagent Strip. The system is available for prescription-use only and is intended for people at risk of kidney disease. Results are used in conjunction with clinical evaluation as an aid in the assessment of kidney health.

The Minuteful - kidney test is comprised of a kit and a smartphone application. It is intended for the semi-quantitative measurement of albumin and creatinine in urine, as well as the presentation of their ratio, the albumin-creatinine ratio (ACR). The Minuteful - kidney test is intended for prescription-use only, as a home-use device to aid in the assessment of kidney health. The results can be used together with clinical evaluation to guide patient care. The device's kit includes a urine receptacle, an ACR Reagent Strip, an absorbing (i.e. "blotting") pad, a proprietary Color-Board and a user manual. The device also consists of an easy-to-use smartphone application, image recognition algorithms, and a physician compendium. The software component of the Minuteful - kidney test consists of both an application (app) and a backend server. Both components encompass different computer vision and machine learning algorithmic components, performing the image analysis activities. The app instructs the user how to accurately administer the test. The Image Validation Transfer System (IVTS) component of the Minuteful - kidney test enables its usage across a wide range of smartphone types and operating systems, essentially making the test platform agnostic.

The AUTION MAX AX-4060 Urinalysis System (AUTION MAX) is comprised of the AUTION MAX AX-4060 automated urine analyzer and AUTION Sticks 9EB multi-parameter test strips. The AUTION MAX AX-4060 urine analyzer, when used with AUTION Sticks 9EB test strips is a fully automated urinalysis system intended for the in vitro qualitative or semi-quantitative measurement of the following analytes: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, turbidity, and color. The test results of these parameters can be used in the evaluation of kidney, urinary, liver and other metabolic disorders. This system is intended to be used by trained operators in clinical laboratories. AUTION Sticks 9EB test strips are test strips for the in vitro qualitative or semi-quantitative measurement of the following analytes: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, and leukocytes with the AUTION MAX AX-4060 urine analyzer. The test results of these parameters can be used in the evaluation of kidney, urinary, liver and other metabolic disorders. Special conditions for use statements: Prescription use only. AUTION Sticks 9EB test strips are not to be read visually.

The AUTION MAX AX-4060 Urinalysis System is a fully automated urine analyzer that provides a semi-quantitative or qualitative measurement for glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrites, leukocytes, specific gravity, turbidity, and color tone. The AUTION MAX AX-4060 Urinalysis System consists of AUTION MAX AX-4060 urine analyzer and AUTION Sticks 9EB test strips. The AUTION Sticks 9EB test strips consist of a plastic strip containing 9 dry chemistry reagent pads impregnated with chemical substances for the determination of the above analytes in urine. These substances if present in urine leads to a chemical reaction that results in a color change, which is measured by the AUTION MAX AX-4060 urine analyzer based on spectrophotometry. In addition, three additional parameters, specific gravity, turbidity, and color tone are directly measured based on reflectance refractometry, transmitted and scattered light measurements.

The Minuteful - kidney test is an in-vitro diagnostic, home-use urine analysis test system for the semi-quantitative measurement of albumin and creatinine in urine, as well as the presentation of their ratio, the albumin-creatinine ratio (ACR). The system consists of a smartphone application, proprietary Color-Board and an ACR Reagent Strip. The system is available for prescription-use only and is intended for people at risk of kidney disease. Results are intended to be used in conjunction with clinical evaluation as an aid in the assessment of kidney health.

The Minuteful - kidney test is comprised of a kit and a smartphone application. It is intended for the semi-quantitative measurement of albumin and creatinine in urine, as well as the presentation of their ratio, the albumin-creatinine ratio (ACR). The Minuteful - kidney test is intended for prescription-use only, as a home-use device to aid in the assessment of kidney health. The results can be used together with clinical evaluation to guide patient care. The device is provided as a kit that comprises a urine receptacle, an ACR Reagent Strip, an absorbing (i.e. "blotting") pad, a proprietary Color-Board and a user manual. The device also consists of an easy-to-use smartphone application, image recognition algorithms, and a physician compendium. The software component of the Minuteful - kidney test consists of both an application (app) and a backend server. Both components encompass different computer vision and machine learning algorithmic components, performing the image analysis activities. The app instructs the user how to accurately administer the test. The Image Validation Transfer System (IVTS) component of the Minuteful - kidney test enables its usage across a wide range of smartphone types and operating systems, essentially making the test platform agnostic.

iQ200 System: The iQ200 automated urine microscopy system is an in vitro diagnostic device used to automate the complete urinalysis profile, including urine test strip chemistry panel and microscopic sediment analysis. Optionally, the iQ200 analyzer can be used as a stand-alone unit, or the results from the iQ200 analyzer can be combined with other urine chemistry results received from an LIS. It produces quantative or qualitative counts of all formed sediments present in urine, including cells, casts, crystals, and organisms. A competent human operator can set criteria for auto-reporting and flagging specimens for review. All instrument analyte image decisions may be reviewed and overridden by a trained technologist. iChemVELOCITY Automated Urine Chemistry System: The iChem VELOCITY automated urine chemistry system is an in vitro diagnostic device used to automate the urine chemistry analysis profile using iChem VELOCITY Urine Chemietry Strips. The iChemVELOCITY can be used as a stand-alone system, as well as in an iQ200 Series system, a configuration given the proprietary name iRICELL as it is designed to be hardware and software compatible with iQ200 Series systems. It produces quantitative results for specific gravity; semi-quantitative results for glucose, blood, leukocyte esterase, bilirubin, urobilinogen, pH, protein, ketones and ascorbic acid: and qualitative results for nitrite, color and clarity. iChemVELOCITY strips are intended for use only with the iChemVELOCITY analyzer. In particular, they are not intended for visual reading. The iChem VELOCITY is not intended to be used as a Point of Care (POC) analyzer. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function. Tests performed using the iChemVELOCITY are intended for clinical laboratory use and in vitro diagnostics use only.

The iQ200 System auto-identifies and processes specimens in 10-position racks by mixing. sampling, and analyzing automatically. The iQ200 Series Automated Urine Microscopy system presents a specimen sandwiched between enveloping layers of lamina to a microscope coupled to a CCD (charge coupling device) video camera. This lamination positions the specimen exactly within the depth of focus and field of view of the objective lens of the microscope. The iQ200 System provides automatic sample handling for automated intelligent microscopy and automatic analyte classification for improved data reporting, presentation and management. Specimens are aspirated by an autosampler rather than poured manually. Individual particle images are isolated within each frame. The Auto-Particle Recognition (APR) software, uses size, shape, contrast and texture features to classify each image into one of 12 categories: RBCs, WBCs, WBC Clumps, Hyaline Casts, Unclassified Casts, Squamous Epithelial Cells, Non-squamous Epithelial Cells, Bacteria, Yeast, Crystals, Mucus and Sperm. Additionally, 27 predefined sub-classifications are available for identifying specific types of casts, crystals, non-squamous epithelial, dysmorphic, and others. Particle concentration is calculated using the number of particles images and the volume analyzed. User-defined release criteria are checked and results are sent to an operator review screen or directly uploaded to the LIS based on these criteria. Specimen results can be edited, imported, and exported. The iQ Body Fluids Module is a software program that runs on the iQ Series Systems and automates body fluid sample handling, capturing particle images in a manner similar to that of the urinalysis application. The iQ200 Series System uses a CCD camera to capture images from each sample. The iChemVELOCITY is an automated urine chemistry system performing measurements of defined physical and chemical constituents in urine. The system utilizes iChemVELOCITY urine chemistry test strips which are read in the Strip Reader Module (SRM) by measuring light reflectance. The device is a fully automated, computer-controlled urine chemistry analyzer intended for use only with iChemVELOCITY Urine Chemistry Strips for the measurement of ten urine chemistry analytes from the chemistry strip plus the measurement of specific gravity using an electronic refractometer assembly and the qualitative measurement of color and clarity by optical absorbance and scattering methods, respectively. It produces quantitative results for specific gravity; semi-quantitative results for glucose, blood, leukocyte esterase, bilirubin, urobilinogen, pH, protein, ketones and ascorbic acid; and qualitative results for nitrites, color and clarity. The primary function of the iQ200 and iChemVELOCITY analyzers is to process samples and provide results to the workstation. The primary functions of the workstation are: user interface, system control, results processing, data storage, and external communications. The analyzers run embedded code on micro controllers and the workstation software runs Microsoft Windows 7 or Windows XP Operating System (OS). The workstation can be connected to: A printer for creating reports; A Laboratory Information System (LIS) for receiving test orders and releasing results.

The ACR | LAB Urine Analysis Test System is comprised of a smartphone application, a proprietary Color-Board, and ACR Reagent Strips. It is intended for the semi-quantitative detection of albumin and creatinine in urine, as well as the presentation of their ratio. The ACR | LAB Urine Analysis Test System is intended for in-vitro diagnostic use by a healthcare professional in a point of care setting. These results may be used in conjunction with clinical evaluation as an aid in the diagnosis for kidney function.

The ACR | LAB Urine Analysis Test System is comprised of a smartphone application, a proprietary Color-Board and ACR Reagent Strips. It is intended for the semi-quantitative detection of albumin and creatinine in urine, as well as the presentation of their ratio. The device is provided as a kit that is comprised of a canister of 100 FDA-cleared urine test strips (ACON Laboratories Inc. Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) k150330), 10 Color-Boards, and a User Manual. The ACR | LAB Urine Analysis Test System also consists of a smartphone application for use on iPhone 7 device (iOS 12), and an image recognition algorithm running on the Backend. The software component of the ACR | LAB consists of both an application (App) and a Backend server (Backend). The App instructs the professional user how to accurately perform the test. The App conducts a series of boundary condition analyses, and if the scan is approved, sends the information to the Backend for complete analysis and results classification. Once analyzed, the results are securely transmitted to a patient Electronic Medical Record for review by a healthcare professional. The patients do not have access to the results at any point during the testing process.

The cobas u 601 urinalysis test system is comprised of the cobas u 601 urine analyzer and the cobas u pack. The cobas u 601 urine analyzer when used with the cobas u pack is a fully automated urinalysis system intended for the in vitro qualitative or semi- quantitative determination of urine analytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, color and erythrocytes, as well as clarity. These measurements are useful in the evaluation of renal, urinary, hepatic and metabolic disorders. This system is intended to be used by trained operators in clinical laboratories. The cobas u pack is a cassette loaded with cobas u 601 test strips for the in vitro qualitative or semi-quantitative determination of pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, color and erythrocytes in urine with the cobas u 601 urine analyzer. These measurements are useful in the evaluation of renal, urinary, hepatic and metabolic disorders.

The cobas u 601 Urinalysis Test System consists of the following components: - . cobas u 601 urine analyzer - . cobas u pack The cobas u 601 urine analyzer is a fully automated urine analysis system. It is optimized for high throughput workloads in the professional environment. The cobas u 601 urine analyzer performs a maximum theoretical throughput of up to 240 samples per hour. The cobas u 601 analyzer consists of several major components: - Rack transport system - Liquid handling system - Test strip cassette compartment - Automated test strip processing area - Photometer which is a 4 wavelength reflectance measuring unit based on a Complementary Metal Oxide Semiconductor chip used in digital cameras (CMOS sensor) - Physical Measurement Cell (PMC): flow cell connected to an optical detector ● - Touch Screen - Inbuilt Computer The functions of the cobas u 601 urine analyzer include: - Sample loading and transport ● - . Sample identification - Robotic pipetting of samples onto test pads on test strips - Robotic aspiration of samples into the PMC - . Controlled incubation - . Photometric measurement of test strips - Optical determination in the PMC - Automatic disposal of used test strips ● - . Result readout - Result memory - Optional formats for data output including electronic result communication The operating system will be a Microsoft Windows for embedded devices. The system will use a Postgres/SQL database. The cobas u 601 urine analyzer is designed to be inter-connected mechanically and electronically with another urine sediment analyzer (cobas u 701) in order to create a urine work area (cobas® 6500). The cobas u pack is a cassette containing 400 tests strips. The cobas u 601 analyzer will use the cobas u pack to dispense single test strips for each sample. Each test strip has ten individual test pads that are used to test for different substances or characteristics. The test strips are analyzed automatically through the analyzer. One test strip is used per sample. When a strip is dispensed for use by the cobas u 601, an aliquot of the urine sample is pipetted onto each of the test pads. The resulting color changes are measured photometrically. The test strip in the cobas u pack cassette ("cassette test strip") is a multi-parameter urine analysis test strip, with test pads for blood (Erythrocytes), Leukocytes, Nitrite, Proteins, Glucose, Ketones, Bilirubin, Urobilinogen, Color and pH.

The DUS R-50S System provides a qualitative measurements for specific gravity, pH, leukocytes, nitrite, protein, glucose, ketone, urobilinogen, bilirubin, blood, microalbumin and creatinine in urine specimens. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections and liver function. The system is intended for prescription, in vitro diagnostic use only.

The DUS R-50S (Urine Chemistry system) is a portable analyzer. It is designed to read only DUS Series for urinalysis. This analyzer reports semi-quantitatively assays for 12 urine analytes [Leukocyte, Nitrite, Urobilinogen, Protein, pH, Blood, Specific gravity, Ketone, Bilirubin, Glucose, Microalbumin, Creatinine]. Reagent strip results are automatically displayed on the screen. The DUS R-50S is intended for in vitro diagnostic use only

The Scanostics UTI Check Application test system consists of the Scanostics UTI Check Application and the URS-2L (UTI) Urine Test Strips. The test system is intended for the qualitative detection of nitrite and leukocytes in urine as an aid in the screening of urinary tract infections (UTI). It is intended for over-the-counter home use only.

The Scanostics UTI Check Application test system consists of the Scanostics UTI Check Application and the URS-2L (UTI) Urine Test Strips. The Scanostics UTI Check Application measures the colour developed in two reaction zones (leukocytes and nitrite pads) on the UTI test strip following application of a urine sample. The developed colors are then compared to calibration colours located on the Scanostics backing material and the result for each pad is determined based on the minimum colour distance between the developed colours and calibration colours. The URS-2L UTI Test Strip comprises of two reagent pads areas, which are absorbent material saturated with chemically active substances, then dried and affixed to the plastic strip with double-sided adhesive. The backing card comprises of thirty-two (32) calibration colour blocks and three (3) black and white alignment squares printed onto a rigid card stock and die cut to provide a groove for the strip (preventing strip misalignment). The use of the backing card is primarily to compensate for different lighting environments as it allows the calibration colours and the test strip to be subjected to the same conditions as the reagent pads for comparison - this would not be possible if the calibration colours were stored within the application itself. The representative platform for the test system is the iPhone 6 with iOS 9. The application has been proven to be compatible on the iPhone 6S (iOS 9) and iPod touch (8th gen with iOS 8 and iOS 9). The application's core technology is based on four (4) patents held by Teco Diagnostics (US 8655009, 8877140, 8911679 and 8506901).