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C.f.a.s. (Calibrator for automated systems) HbA1c is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet.

C.f.a.s. HbA1c is single-level lyophilized calibrator based on hemolyzed sheep blood and human blood. The concentrations of the calibrator components have been adjusted to ensure optimal calibration of the appropriate Roche methods on clinical chemistry analyzers. During use, calibrator dilutions are prepared automatically on-board the analyzer resulting in six levels.

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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The tHb Cal Standard is intended for use in calibrating the total hemoglobin channel of the IL CO-Oximeters and Oximeters.

The product encompassed by this 510(k) submission is a Class II (81KRZ) In Vitro Diagnostic Solution manufactured by ALKO Diagnostic Corporation. The tHb Cal Standard is intended to serve as direct replacement to like named product manufactured by Instrumentation Laboratory Company. ALKO Product A331-50 (tHb Cal Standard) is equivalent to Instrumentation Laboratory product 33150-50 (Cal Dye and Reference Standard). ALKO uses a similar composition, description and packaging design as that used by Instrumentation Laboratory Company in its products.