Clay Adams QBC Centrifugal Hemotology

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K813033 ↗

FDA Product Code

GKG

Device Class

Class II

Regulation

21 CFR Part 864.6400

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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• What clinical applications does the Clay Adams QBC Centrifugal Hemotology support in a lab setting?

  The Clay Adams QBC Centrifugal Hemotology is designed specifically for hematology applications, particularly to process blood samples by centrifuging them in tubes. This separation of cellular components from plasma enables accurate measurement of key hematological parameters, such as hematocrit levels, red blood cell count, and hemoglobin concentration. It is intended for use in clinical laboratories to assist in these diagnostic evaluations.

• Is the Clay Adams QBC Centrifugal Hemotology a single-use or reusable device, and what model variations are available?

  The Clay Adams QBC Centrifugal Hemotology is a reusable instrument, not intended for single-use. It comes with multiple model references, including 3006697110, 3017065670, and several others like 3008717264 and 3000203293, which may correspond to different configurations or capacities for laboratory use.

• How is the Clay Adams QBC Centrifugal Hemotology regulated, and what does its FDA clearance status indicate?

  The Clay Adams QBC Centrifugal Hemotology received FDA 510(k) clearance under the classification of Class II medical devices, indicating it has been determined to be substantially equivalent to a legally marketed device. This clearance is specific to its intended use in hematology, particularly for centrifuging blood samples to measure hematocrit and related parameters. The device is regulated under FDA regulation number 864.6400.

• What storage or handling considerations should be noted for the Clay Adams QBC Centrifugal Hemotology?

  Since the Clay Adams QBC Centrifugal Hemotology is a reusable instrument, proper cleaning and maintenance are essential to ensure its performance and longevity. While the data does not specify storage conditions, standard practices for reusable medical devices—such as keeping it in a clean, dry environment and following manufacturer guidelines—should be followed. There is no indication of sterility, so it is not intended for sterile procedures.

• What is the intended regulatory route for this device, and how does it relate to its classification?

  The Clay Adams QBC Centrifugal Hemotology was cleared through the traditional 510(k) pathway, reviewed by the Hematology (HE) advisory committee. This process confirms its substantial equivalence to a predicate device and classifies it as a Class II medical device under FDA regulation 864.6400. The product code (GKG) and advisory committee review reflect its specialized role in hematology diagnostics.