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The iQ 200 System is intended for analysis of urine chemistry, color, clarity, specific gravity, and formed sediment elements, which constitutes typical routine urinalysis. The iQ 200 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 iQ 200 Analyzer can be used as a stand-alone unit, or the results from the iQ 200 Analyzer can be combined with other urine chemistry results received from an LIS. It produces quantitative or qualitative counts of all formed sediment elements 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. The iQ 200 System is intended for analysis of urine chemistry, specific gravity, and formed sediment elements, which constitutes typical routine urinalysis. Urinalysis is ordered by physicians as a screening procedure for detection of possible abnormal metabolic or systemic disease, indicated by chemical composition of urine, and of potential renal or urinary tract disease or dysfunction, indicated by urine concentration and by the nature and distribution of urinary formed elements. Urine profile testing is commonly employed in the initial clinical evaluation of patients admitted for hospital care or undergoing physical examinations. Routine urinalysis is also indicated in diagnosis of patients with possible renal or urinary tract infection, carcinoma, or other injury, as well as for monitoring the status and effectiveness of drug, radiation, or dietary therapy, and of postsurqical or post-therapeutic recovery. The information produced by the iQ 200 System concerning the composition of patient urines is ordered at the discretion of the physician, and is part of a larger body of laboratory and other test results available to assist the physician in health assessments or differential diagnoses. Routine urinalysis findings are always subject to judgment and interpretation by physicians relative to the patient's overall clinical presentation and history.

The iQ 200 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. Each image is analyzed and assigned a classification by an auto analyte recognition algorithm. Using these classifications and the known observation volume, microscopic analyte concentrations may be automatically reported. If results from a specimen are not autoreported, microscopic examination results are displayed on an independent Computer WorkStation. Operators can then confirm or modify analyte classifications and release reports off-line for enhanced convenience, obviating the need to process a second aliquot for review. Chemistry results from the companion ARKRAY AUTION MAX AX-4280 are automatically consolidated by the Computer WorkStation for display and reporting.

The Yellow IRIS is used by a competent human operator to produce a complete urinalysis profile, including chemistry, sediment microscopy and specific gravity determinations. It is capable of detecting and reporting all types of formed urine sediment elements and of quantitating such elements, when desired, based on observed proportion of total particulate count. The Yellow IRIS is intended to replace the conventional intensive manipulatively manual complete urinalysis procedure as well as the abbreviated.

The Yellow IRIS urinalysis workstation, an already existing commercial in-vitro diagnostic device

The White IRIS is a leukocyte differential analyzer intended for in vitro diagnostic use in determining the proportional leukocyte count (WBC differential) on peripheral blood specimens that have been flagged by an automated hematology analyzer performing differential counts as well as for peripheral blood specimens for which no automated differential has been performed.

Combining unique cytoprobe, rapid hemacyte fractionation and novel color image analysis, The White IRIS extends automated intelligent microscopy to leukocyte differentiation. It provides flow cytometry precision and microscopical resolution to review specimens flagged by hematology analyzers with differential capabilities or to complement other analyzers without these capabilities. The system includes compartments for closed sampling, rapid leukocyte-rich plasma preparations, cytoprobeinduced metachromasia, and collection and color analysis of leukocyte images, and presents the results as a single-view 500-cell differential on a 20-in touchscreen monitor for examination by a skilled competent observer.

The 900UDx Urine Pathology System performs routine urinalysis, including urine chemistry, specific gravity, and sediment microscopic examination.

The 900UDx Urine Pathology System provides automatic sample handling for automated intelligent microscopy and improved data presentation and management. Specimens are aspirated by an autosampler rather than poured manually. Microscopic examination results are displayed on an independent ViewStation computer with higher image resolution, and operators can confirm and release reports off-line for enhanced convenience. Chemistry results from the external Boehringer Mannheim Hitachi CHEMSTRIP® Super UA Urine AnalyzerTM are automatically consolidated by the ViewStation for display and reporting.