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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY AND INSTRUMENT COMBINATION TEMPLATE. 510(k) Number:
k173345
B. Purpose for Submission:
Addition of ketone detection functionality
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What is 510k substantial equivalence determination?
510k substantial equivalence determination is a premarket submission made to FDA to demonstrate that a new medical device is substantially equivalent to a predicate device already on the market.
Who is required to file 510k substantial equivalence determination?
Manufacturers of medical devices looking to bring a new device to market are required to file a 510k substantial equivalence determination.
How to fill out 510k substantial equivalence determination?
To fill out a 510k submission, manufacturers must provide detailed information about the new device, demonstrate its similarities to a predicate device, and provide data supporting its safety and effectiveness.
What is the purpose of 510k substantial equivalence determination?
The purpose of a 510k submission is to demonstrate that a new medical device is as safe and effective as a legally marketed predicate device.
What information must be reported on 510k substantial equivalence determination?
Information such as device description, labeling, intended use, technological characteristics, performance data, and clinical studies must be reported on a 510k submission.
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