The Babson Sample Preparation Device is a class I exempt device that falls within 21 CFR 862.2050, General purpose laboratory equipment labeled or promoted for a specific medical use, in accordance with FDA regulations. It serves as a sample preparation device used to automate the mixing, centrifugation, and refrigeration of capillary blood samples for chemistry and hematology testing. The Babson Sample Preparation Device is not an analyzer and does not produce test results.The Babson Sample Preparation Device is intended for use only with the Becton, Dickinson, and Company’s BD MiniDraw ™ H&H ™ Capillary Blood Collection Tube and BD MiniDraw ™ SST ™ Capillary Blood Collection Tube, which are used to collect capillary blood from the customer’s fingertip; the H&H will be mixed, and the SST will be mixed and centrifuged by the Babson Sample Preparation Device. The device is intended to be able to process up to 60 tubes per day across multiple customers.
An electrically-powered device intended to be used to separate the components of multiple types and various volumes of clinical suspensions using centrifugal force. It is a self-contained unit with an electric motor, a vertical shaft, and a horizontal rotor attached to the upper end. It is typically used to centrifuge various types of clinical specimens, either alone or after addition of reagents or other additives, for subsequent in vitro diagnostic analysis. It may additionally have refrigeration capabilities to perform temperature-sensitive procedures.