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Thermo Fisher Achieves ISO 13485 Certification as Vendors Continue Prepping LC-MS for the Clinic


Thermo Fisher Scientific said this week that two of its facilities have achieved ISO 13485 certification, moving the company forward in its efforts to develop liquid chromatography-mass spectrometry systems for clinical use.

The facilities in San Jose, Calif., and Franklin, Mass., are the first liquid chromatography and mass spec sites of Thermo Fisher to receive such certification, a standard of quality management for the design and manufacture of medical devices, it said. With the certification, the firm's TLX multiplexed HPLC platforms and a number of its mass specs will be designed and manufactured under this standard, setting the stage for the platforms to potentially receive CE-IVD device registration in Europe and Class-1 medical device listing in the US, Thermo Fisher said.

"This is a critical step in our ongoing initiative to develop LC-MS-based devices for the clinical market," Dan Shine, president of Thermo Fisher's chromatography and mass spec business, said in a statement. "The medical community is expressing great interest in utilizing LC-MS technology, and we're aggressively developing tools to address this growing demand."

The moves are the latest sign of mass spec vendors' interest in prepping their instruments for the move into the clinic.

Last month, for instance, AB Sciex released two new LC-MS/MS systems – the AB Sciex API 3200MD and 3200MD QTRAP – that it has registered with the US Food and Drug Administration as Class I exempt medical devices and is marketing for use as in vitro diagnostic devices (PM 2/15/2013).

"Clinical diagnostics is the new frontier for mass spectrometry," AB Sciex president Rainer Blair said in a statement following release of the new devices. "The introduction of the 3200MD series is a major milestone for AB Sciex itself in response to the demand in clinical settings for mass spectrometers as medical devices that meet regulatory requirements."

And, last year, Agilent registered its Infinity Series 1200 liquid chromatography systems and 6000 Series mass spectrometry systems with FDA as Class I medical devices (PM 1/20/2012).

Waters has also registered certain of its mass spec instruments as Class I devices.