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Thermo Fisher Registers HPLC as FDA Class I Medical Device; Inks Reseller Deal with Prosolia

NEW YORK (GenomeWeb) – Thermo Fisher Scientific today said that has listed its Prelude LX-4 MD HPLC as a Class I medical device with the US Food and Drug Administration for general clinical use. 

The firm also said it inked a reseller agreement with Prosolia for that firm's automated sample handling and ionization source for mass spectrometry. 

The Prelude LX-4 MD HPLC features four parallel channels to deliver up to four different separations to a mass spec in order to enhance sample throughput. Thermo said that the channels can run identical or different methods simultaneously. 

Class I classification is for devices that pose the least risk to patients, and Class I devices are the least regulated under FDA's three classifications. 

In a statement, Thermo Fisher President of Chromatography and Mass Spectrometry Dan Shine said that the company is committed to bringing LC-MS to the clinical market, "and this product is part of a larger initiative to make mass spectrometry more useful and accessible to the clinician." 

Last June, Thermo Fisher registered its San Jose, Calif. facility with FDA as a medical device establishment, allowing the firm to design and manufacture devices for analyzing samples from patients for in vitro diagnostic purposes.

Separately today, the company said it has reached a reseller deal with Prosolia to sell the Prosolia Velox 360 device with Thermo Fisher's mass spec instruments. The agreement provides a single point of contact for purchasing, installation, and service. 

The Velox 360 is an automated sample handling and ionization source for mass spec. It features paper spray technology, which combines paper substrates with electrospray ionization for simple sample preparation and the acceleration of mass spec analysis of biological fluids. 

The Velox 360 can be coupled with Thermo Fisher's Q Exactive Series mass spec instruments and the firm's triple quadrupole and ion trap instruments.