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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY AND INSTRUMENT COMBINATION TEMPLATE. 510(k) Number:
k170241
B. Purpose for Submission:
New device
C. Measured:
Capillary whole blood
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How to fill out 510k substantial equivalence determination
How to fill out 510k substantial equivalence determination
01
To fill out 510k substantial equivalence determination, follow these steps:
1. Gather all necessary information and documentation about the medical device you are seeking approval for.
2. Identify the predicate device that you believe your device is substantially equivalent to.
3. Conduct a thorough comparison between your device and the predicate device, focusing on technological characteristics, intended use, and performance.
4. Prepare a detailed written summary of the comparison, highlighting the similarities and differences between your device and the predicate device.
5. Complete the necessary forms and paperwork required by the FDA, including the 510k application form.
6. Submit the completed application, along with all supporting documentation, to the FDA for review.
7. Cooperate and provide any additional information or clarifications requested by the FDA during the review process.
8. Await the FDA's determination of substantial equivalence for your device.
02
Who needs 510k substantial equivalence determination?
01
Any medical device manufacturer or distributor who wishes to market a new medical device in the United States needs to go through the 510k substantial equivalence determination process. This applies to both domestic and foreign manufacturers who want to sell their devices in the U.S. market.
02
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What is 510k substantial equivalence determination?
A 510k substantial equivalence determination is a premarket submission made to FDA to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.
Who is required to file 510k substantial equivalence determination?
Manufacturers of medical devices intending to market a new device in the United States are required to file a 510k substantial equivalence determination.
How to fill out 510k substantial equivalence determination?
To fill out a 510k substantial equivalence determination, manufacturers must provide detailed information about the new device, including its intended use, design, materials, and clinical testing data.
What is the purpose of 510k substantial equivalence determination?
The purpose of 510k substantial equivalence determination is to demonstrate that a new device is as safe and effective as a predicate device that is already legally marketed.
What information must be reported on 510k substantial equivalence determination?
Manufacturers must report information such as device description, intended use, labeling, technological characteristics, and performance testing results on a 510k substantial equivalence determination.
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