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For In Vitro Diagnostic Use Intelligent Medical Imaging, Inc.'s MICRO21® with Urine Sediment Analysis is a laboratory instrument for locating, digitally storing and displaying microscopic fields of view from urine sediments in a urine slide for examination by a qualified individual for use in reporting a urine microscopic result.

The MICRO21 with Urine Sediment Analysis, is an automated microscopic system that locates formed elements of wine sediment, digital stores images of the constituents and displays the images in an organized manner to aid technologists in performing an Urine Sediment Analysis procedure. The MICRO21 process is substantially equivalent to the manual microscopic process.

For In Vitro Diagnostic Use Intelligent Medical Imaging, Inc.'s MICRO21 with WBC Estimate is a laboratory instrument for locating, digitally storing and displaying white blood cells to aid the technologist in performing the WBC Estimate. Examination and determination of the results must be performed by qualified individuals.

The MICRO21 with WBC Estimate is a new intended use that follows the same process as the currently approved MICRO21 with White Blood Cell (WBC) Differential (Diff). The MICRO21 with WBC Diff, Ref. No. K925670/A, is an automated microscopic system that locates WBCs, stores digital images of the cells and displays the images in an organized manner to aid technologists in performing the WBC Diff procedure. The MICRO21 process is substantially equivalent to the manual microscopic process. The MICRO21 with WBC Estimate is an automated microscopic procedure that calculates an estimate of WBCs/uL using the information collected during the MICRO2/ with WBC Differential. Upon completion of the review process by a technologist, an algorithm calculates the WBC Estimate by using the number of classified WBCs and the number for low-power (200x magnification) fields visited. An estimated range for the WBCs/uL is calculated and reported.

Intelligent Medical Imaging, Inc.'s MICRO21™ with Cerebrospinal Fluid (CSF) is a laboratory instrument used to perform cytological analysis by locating, digitally storing and displaying nucleated cells in human cerebrospinal fluid preparations. Examination of cellular morphology and classification must be performed by qualified individuals.

The MICRO21™ with Cerebrospinal Fluid is a new procedure for the MICRUZ/ with the tollowing in vitro diagnostic intended use: Intelligent Medical Imaging, Inc.'s MICRO21™ with Cerebrospinal Fluid (CSF) is a laboratory instrument used to perform cytological analysis by locating, digitally storing and displaying nucleated cells in human cerebrospinal fluid preparations. Examination of cellular morphology and classification must be performed by qualified individuals. A summary of the MICRO21 with Cerebrospinal Fluid process is as follows: - Patient CSF samples are prepared using the cytocentrifugation method for specimen concentration 1. using the Cytospin® centrifuge. . . - Each slide has a black mask over the non-frosted portion with a hole in the mask for specimen 2. placement. - 3. The slide is stained using Wright's stain. - The slides are barcoded and placed into a frame holder, and the frame is placed on the MICRO21 for 4. processing. - ડ. The MICRO21 locates nucleated cells. - The nucleated cell images are stored by the instrument and displayed on a color monitor for review by 6. a technologist. - The technologist reviews the images and confirms each cell type. 7. - 8. A report of the CSF result for each patient is printed.

The MICRO21 with nDNA is a new MICRO21 intended use that follows the same process as the MICRO21 with WBC Diff, but instead locates, digitally stores and displays nDNA Images to aid the technologist in performing a nDNA Screen for Positive or Negative results. A nDNA Screen is a microscopic exam of a patient serum sample that has been set-up using an indirect enzyme antibody test for the semi-quantitative detection of nDNA which is an aid in the detection of systemic rheumatic disease.

The MICRO21 with nDNA is a new MICRO21 intended use that follows the same process as the MICRO21 with WBC Diff, but instead locates, digitally stores and displays nDNA Images to aid the technologist in performing a nDNA Screen for Positive or Negative results. A nDNA Screen is a microscopic exam of a patient serum sample that has been set-up using an indirect enzyme antibody test for the semi-quantitative detection of nDNA which is an aid in the detection of systemic rheumatic disease. The nDNA Test System used on the MICRO21 is Immuno Concepts® Colorzyme® nDNA Test System. A summary of the MICRO21 with nDNA process is as follow: 1. Patient serum samples are prepared following the Color zyme Test Procedure and then placed in designated wells on the nDNA slide. 2. Each slide has three control wells and nine patient wells. 3. Barcode the slides, place the slides into a frame holder, and insert the slides on the MICRO21 for processing. 4. The MICRO21 locates the central area of each well on the slide and captures four images from each well. 5. The nDNA images are stored by the instrument and displayed on a color monitor for review by a technologist. 6. The technologist reviews the images and confirms a positive determination by selecting the appropriate result. 7. A report of the nDNA screening result for each patient well is printed.

The MICRO21 with ANA is a new MICRO21 intended use that follows the same process as the MICRO21 with WBC Diff, but instead locates, digitally stores and displays ANA Images to aid the technologist in performing an ANA Screen for Positive or Negative results. An ANA Screen is a microscopic exam of a patient serum sample that has been set-up using an indirect enzyme antibody test for the semi-quantitative detection of antinuclear antibody (ANA) which is an aid in the detection of systemic thematic disease.

The MICRO21™ with WBC Diff (White Blood Cell Differential) Ref. No. K925670/A is an automated microscopic system that locates WBCs, stores digital images of the cells and displays the images in an organized manner to aid technologists in performing the WBC Diff procedure. The MICRO21 process is substantially equivalent to the manual microscopic process. The MICRO21 with ANA is a new MICRO21 intended use that follows the same process as the MICRO21 with WBC Diff, but instead locates, digitally stores and displays ANA Images to aid the technologist in performing an ANA Screen for Positive or Negative results.

The MICRO21 with Retic is a new MICRO21 intended use that follows the same process as the MICRO21 with WBC Diff, but instead locates, digitally stores and displays reticulated red blood cells (retics) to aid the technologist in performing the Reticulocyte Count procedure.

The MICRO21 with Retic is an automated microscopic system that locates reticulated red blood cells (retics), stores digital images of the cells and displays the images in an organized manner to aid technologists in performing the Reticulocyte Count procedure. The process involves preparing a blood wedge smear stained with a supravital stain, affixing a bar code to each slide, placing the slides into a frame holder and inserting the frame into the MICRO21. The instrument locates 1000 RBCs. The reticulated RBCs are stored as high magnification color images (1000x magnification). The images of retics stored by the instrument are displayed on a color monitor for review by a technologist. The technologist confirms that each reticulated RBC image displayed contains retic markings. If the image does not contain retic markings, the image is eliminated by the technologist and consequently not included in the retic count. A report of the percent of retics per 1000 RBCs is printed.