Hematology Calibrator

No FDA recalls on record, checked 22 Oct 2026.

Full name

Hemotology Calibrator

510(k) Number

K813530 ↗

FDA Product Code

KSA

Device Class

Class II

Regulation

21 CFR Part 864.8185

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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• What is the primary purpose of the Hematology Calibrator from American Dade in a clinical hematology lab?

  The Hematology Calibrator ensures the accuracy and reliability of hematology analyzers by providing standardized reference values for calibrating instruments that measure red blood cell and white blood cell counts. This helps maintain precision in diagnostic testing, which is critical for accurate patient care.

• Is the Hematology Calibrator available in single-use or reusable options, and how should I determine which version to purchase?

  The Hematology Calibrator is supplied as either single-use or reusable, depending on the specific model. To determine which version to purchase, check the product documentation or consult with American Dade’s technical support, as the choice depends on your lab’s workflow, cost considerations, and compliance with sterility or reprocessing protocols.

• What regulatory pathway does the Hematology Calibrator follow, and what does this mean for my lab’s compliance?

  The Hematology Calibrator is cleared by the FDA under the 510(k) pathway (K813530) and classified under product code KSA as a Class II device with special controls. This means it has undergone FDA review to demonstrate substantial equivalence to a predicate device, ensuring it meets established safety and performance standards for use in clinical hematology labs.

• Are there multiple models of the Hematology Calibrator, and if so, how can I identify which one aligns with my lab’s hematology analyzers?

  Yes, the Hematology Calibrator comes in multiple models, as indicated by the various FEI numbers (e.g., 3002808301, 3007603826) and registration numbers listed. To identify the correct model for your lab’s analyzers, refer to the manufacturer’s compatibility guidelines or contact American Dade directly, as specific calibrators may be designed for particular analyzer systems.