“We got an official FDA review letter just
before Christmas. That letter did not contain
a single question on Software and
Instrumentation. We asked the FDA reviewer
if there would be any more questions
regarding the submission. The reviewer said
that this was the complete review. So Code
Refinery many kudos to you!”
— Global Project Management
bioMérieux Inc , Durham, NC
bioMérieux Inc , Durham, NC
Case Study
FDA 510(k) clearance received for the NucliSens EasyQ Enterovirus System.
CHALLENGE
Develop FDA 510(k) documentation for the Software and Instrumentation sections of a submission package for a diagnostic system used for Enterovirus testing.
RESULTS DELIVERED
Code Refinery assessed current documentation to
determine if any gaps existed for the FDA 510(k)
submission and recommended and implemented action
plan in order to meet requirements for a FDA 510(k)
device submission.
CONFIDENTIAL: The information presented is considered the property of Code Refinery, LLC and has been prepared on a confidential basis solely for the benefit of selected individuals and institutions.
Code Refinery completely documented Instrumentation and Software sections for FDA 510(k) as well as project and technical oversight. bioMérieux received a FDA 510 (k) for the NucliSens EasyQ Enterovirus submission K063261.
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