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The CDS Hematology Calibrator for red cell, white cell and platelet counting is a device that resembles red cells, white cells and platelets in whole blood specimens and is intended to serve as a calibration standard for automated hematology analyzers, including Beckman Coulter: S-Plus IV-VI series, STKR, JS, JR, ST and JT series, STKS, MAXM, MD, Counto, OnyX, T series and A . T and A . T diff series analyzers; the Abbott Cell-Dyn 1100, Cell-Dyn 1400, 1500, 1600 and 1700 analyzers; and the Danam EXCEL 16 and EXCEL 22 and Coulter Ac T diff analyzers used to count red cells, white cells and platelets. It is a stable suspension of particles whose size, shape, concentration and other characteristics have been precisely and accurately determined.

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This document is a 510(k) premarket notification decision letter from the FDA for the CDS Hematology Calibrator (CDS CAL). It states that the device is substantially equivalent to legally marketed predicate devices, meaning it can be marketed. However, the document does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it include details about performance, sample size, ground truth, or expert qualifications.

Therefore, I cannot provide the requested information based on the provided text. The document focuses on regulatory approval based on "substantial equivalence" rather than detailed performance metrics and studies.

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