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The X100/X100HT with Full Field Peripheral Blood Smear Application is intended to locate and display images of white cells, red cells, and platelets acquired from fixed and stained peripheral blood smears and assists a qualified technologist in conducting a WBC differential, RBC morphology evaluation, and platelet estimate using those images. For in-vitro diagnostic use only. For professional use only.

The X100 / X100HT with Full Field Peripheral Blood Smear (PBS) Application ("Full Field PBS") is a digital cell morphology solution, presenting high resolution digital images of fixed and stained microscopy Peripheral Blood Smears. The Full Field PBS was previously cleared by the Agency on October 2, 2020, throughout the review of K201301 and on May 3, 2022, throughout the review of K220013. The system automatically locates and presents images of peripheral blood cells and streamlines the PBS analysis process with a review workflow composed of four steps: (1) full field review, (2) white blood cells (WBC) review (DSS for WBC Pre-Classification is available), (3) red blood cells (RBC) review and (4) platelet review (DSS for platelet estimation is available). Under the proposed modification, subject of this 510(k) submission, additional DSS component is added to the RBC and Platelet review steps. Concerning RBC analysis, system-suggested RBC morphological pre-gradings are added as proposed DSS to the user by means of a dotted line around a suggested grading selection box. Notably, the user is still required to review the slide and actively mark the final grading, exactly as performed in the cleared workflow review. The same approach is used with regard to the update to the platelet review step; A system-suggested platelet clump indication is presented to the user by means of a dotted line around a selection box. Notably, the user is still required to manually mark whether platelet clumps were detected, exactly as currently performed in the cleared workflow review. The changes under discussion do not affect the cleared indications for use or intended use; the user's workflow of scanning and analyzing peripheral blood smears using the Full Field PBS Application remains otherwise unchanged as well.

The X100 with the Full Field Bone Marrow Aspirate (BMA) Application is an automated cell locating device, intended for in vitro use only. The Full Field BMA application automatically locates and presents images of hematopoietic cells to trained operators for visual evaluation of Romanowsky stained bone marrow aspirate (BMA) smears. The Full Field BMA application assists trained operators to perform bone marrow smear quality assessment, blast cell, plasma cell, and M:E ratio estimation. A qualified operator must review, confirm or modify classification of each cell according to type, and verify results before finalizing and releasing the report. The X100 with the Full Field Bone Marrow Aspirate (BMA) application presents images of Prussian Blue stained BMA smear. X100HT with Full Field BMA Application: The X100HT with the Full Field Bone Marrow Aspirate (Full Field BMA) Application is an automated cell locating device. intended for in vitro use only. The Full Field BMA application automatically locates and presents images of hematopoietic cells to trained operators for visual evaluation of Romanowsky stained bone marrow aspirate (BMA) smears. The Full Field BMA application assists trained operators to perform bone marrow smear quality assessment, blast cell, plasma cell, and M:E ratio estimation. A qualified operator must review, confirm or modify classification of each cell according to type, and verify results before finalizing and releasing the report. The X100HT with the Full Field Bone Marrow Aspirate (BMA) application presents images of Prussian Blue stained BMA smear.

The X100 and X100HT instruments include a digital scanner and processing unit (computer) capable of acquiring high-resolution digital images from Romanowsky or Prussian Blue stained BMA slides with software application (Full Field Bone Marrow Aspirate (BMA) Application) for evaluation of acquired images. The X100 allows for three slides while X100HT comes with an additional component, a slide loader, a mechanical loading mechanism that holds up to 30 slides in three 10-slide cassettes and performs cover slipping and slide loading into the X100 scanner. The Full Field BMA application contains two scan modes - Romanowsky stain and Prussian Blue stain.

The X100HT with Full Field Peripheral Blood Smear (PBS) Application is intended to locate and display images of white cells, red cells, and platelets acquired from fixed and stained peripheral blood smears and assists a qualified technologist in conducting a WBC differential, RBC morphology evaluation, and platelet estimate using those images. For in vitro diagnostic use only. For professional use only.

X100HT with Full Field Peripheral Blood Smear (PBS) Application automatically locates and presents high resolution digital images from fixed and stained peripheral blood smears. The user browses through the imaged smear to gain high-level general impressions of the sample. In conducting white blood cells (WBC) differential, the user reviews the X100HT with Full Field PBS suggested classification of each automatically detected WBC and may manually change the suggested classification of any cell. In conducting red blood cells (RBC) morphology evaluation, the user can characterize RBC morphology on observed images. In conducting platelets estimation, the user reviews each automatically detected platelet and the suggested platelets estimation and may manually change the detections or the estimation. The X100HT with Full Field PBS enables efficient slide loading by providing three cassettes, each can be loaded with up to ten peripheral blood smear slides. The slide loader automatically adds mounting media and coverslips to the slides and loads them into the X100 for scanning and analysis. The X100HT with Full Field PBS is intended to be used by skilled users, trained in the use of the device and in the identification of blood cells.

The X100 with Field Peripheral Blood Smear Application is intended to locate and display images of white cells, red cells, and platelets acquired from fixed and stained peripheral blood smears and assists a qualified technologist in conducting a WBC differential, RBC morphology evaluation, and platelet estimate using those images. For in vitro diagnostic use only. For professional use only.

X100 with Full Field Peripheral Blood Smear Application (Scopio's Full Field PBS) automatically locates and presents high resolution digital images from fixed and stained peripheral blood smears. The user browses through the imaged smear to gain high-level general impressions of the sample. In conducting white blood cells (WBC) differential, the user reviews the suggested classification of each automatically detected WBC, and may manually change the suggested classification of any cell. In conducting red blood cells (RBC) morphology evaluation, the user can characterize RBC morphology on observed images. In conducting platelets estimation, the user reviews each automatically detected platelet and the suggested platelet estimation, and may manually change the detections or the estimation. The X100 with Full Field Peripheral Blood Smear Application is intended to be used by skilled users, trained in the use of the device and in the identification of blood cells.