This story originally ran on Jan. 17.
SAN DIEGO – Agilent said this week that it has 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.
The move stems from an acknowledgment that these systems are currently being used in clinical settings and a recognition of mass spec's growing usefulness as a clinical tool, Gustavo Salem, vice president and general manager of Agilent's Biological Systems Division, told ProteoMonitor this week at the Mass Spectrometry: Applications to the Clinical Laboratory annual meeting here.
"We know that many of these systems today are being used in a CLIA setting," Salem said, adding that, given recent FDA pronouncements, Agilent believes that having these systems registered as Class I medical devices "will be of importance in the marketplace."
Specifically, in June 2011 FDA issued a draft guidance on research-use-only and investigational-use-only in vitro diagnostic products in which it said that device manufacturers like mass spec vendors "should not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."
Whether the agency will follow this draft guidance with any sort of binding regulation remains to be seen, Salem said, "but our knowledge is that [our] customers are using [LC and mass spec] products that are today basically considered general-purpose instruments in a clinical setting, so we felt that it was appropriate that we acknowledge that these are Class I medical devices."
Registration is also an "acknowledgment that we're seeing more and more of our business focused on the clinical laboratory," he said. "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."
Mass spec-based proteomics has yet to make it into the clinic in a significant way, but Agilent has been one of the more active mass spec vendors in terms of researching and refining clinical proteomics workflows. Last week, for instance, the company announced it had entered into a strategic partnership with diagnostics firm Integrated Diagnostics to help move protein-based tests for lung cancer and Alzheimer's into the clinic. (PM 1/13/2012). It also has an ongoing collaboration with proteomics researcher Leigh Anderson to optimize workflows for his stable isotope standards and capture by anti-peptide antibodies, or SISCAPA, assay.
Agilent's registration efforts will focus initially on its 1260 Infinity LC and its 6430 and 6460 triple quadrupole machines, "which are the primary products we get called for today in the clinical laboratory," Salem said. He added that Agilent may in the future pursue registration for additional machines such as its 6490 triple quad or some of its time-of-flight instruments.
Although the Class I registration process is much less demanding than, for instance, a 510(k) approval, it does involve "significant incremental responsibility," Salem said.
"Once [an instrument] is registered as a [Class I exempt] device, we are now open to inspection by the FDA, and we are now responsible for the ability to track certain characteristics of the product and product development," he said. "The evolution of the product's design control features; acknowledging corrective action systems and quality management system components – all of that is now a standard that is expected of us both by customers and regulators."
In a 2011 interview with ProteoMonitor, Mya Thomae, CEO of IVD regulatory consulting firm Myraqa noted that these requirements, while not particularly onerous, could constrain vendors' ability to upgrade their instrumentation.
“If you’re not under the quality systems regulation, you have a lot more flexibility in terms of upgrading your instrument, changing things around, and not needing the same level of documentation,” she said. “So, particularly for technologies that are moving quickly, the [research-use-only] environment allows [firms] a lot more flexibility.”
Registration "does change some elements of our business model," Salem said, noting that such factors were the primary driver of Agilent's decision to start with older platforms like the 6430 and 6460 as opposed to the newer 6490.
With the announcement, Agilent joins Waters as the two vendors that have registered certain of their mass spec instruments with FDA as Class I exempt devices.
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