This story originally ran on Feb. 27.
AB Sciex said this week that it has achieved ISO 13485 certification for its quality management system, a key step in obtaining European regulatory clearance for clinical use of its liquid chromatography and mass spectrometry instruments.
The company's LC-MS systems are currently for research use only, but, AB Sciex president Rainer Blair said in a statement, the company "is taking the necessary steps to be compliant with regulatory requirements that govern entry into clinical diagnostics."
"Achieving the ISO 13485 certification is an important measure toward realizing the vision of our LC/MS/MS systems to be cleared for use in clinics," he said. "The potential impact of mass spectrometry technologies on clinical diagnostics is significant."
The certification covers AB Sciex's manufacturing facility in Singapore and its R&D facility in Toronto.
The company is not alone in prepping its instruments for the clinical space. Last month, Agilent registered its Infinity Series 1200 liquid chromatography systems and 6000 Series mass spectrometry systems as Class I medical devices with the US Food and Drug Administration, making it the second mass spec vendor – following Waters – to register certain of its mass specs with FDA.
In an interview with ProteoMonitor following the registration, Gustavo Salem, vice president and general manager of Agilent's Biological Systems Division, said it stemmed from an acknowledgment that these systems were currently being used in clinical settings and a recognition of mass spec's growing usefulness as a clinical tool (PM 12/20/2012).
"We know that many of these systems today are being used in a CLIA setting," Salem said. "We're seeing more and more of our business focused on the clinical laboratory," he added. "It's an important market. It's a strategically critical opportunity for us to continue to participate with the customers in these [clinical] laboratories, and we just think that there will continue to be more and more adoption of mass spectrometry in the clinical setting."
In June 2011, FDA issued a draft guidance on research-use-only and investigational-use-only in vitro diagnostic products in which it said that device manufacturers like mass spec vendors "should not sell such products to laboratories that they know use the product for clinical diagnostic use."
Agilent obtained ISO 13485 certification for the manufacture of its LC-MS systems in September of 2011 (GWDN 9/7/2011).