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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE. 510(k) Number: k171971 B. Purpose for Submission: New Device C. Measured: Alkaline phosphate
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How to fill out 510k substantial equivalence determination

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Step 1: Gather all the necessary documentation needed for the substantial equivalence determination.
02
Step 2: Fill in the required information in the Form 510k.
03
Step 3: Attach all the supporting documents
04
Step 4: Review and double-check all the information filled in the form.
05
Step 5: Submit the completed Form 510k and supporting documents to the relevant regulatory authority.

Who needs 510k substantial equivalence determination?

01
Medical device manufacturers who intend to market a new device that is similar to an existing device already cleared by the regulatory authority.
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510(k) substantial equivalence determination is a premarket submission made to the FDA (Food and Drug Administration) to demonstrate that a new medical device is substantially equivalent to a predicate device that is already legally marketed.
Manufacturers of new medical devices that are not considered to be exempt from the 510(k) premarket notification requirements are required to file for substantial equivalence determination.
To fill out a 510(k) substantial equivalence determination, manufacturers need to provide detailed information about the new medical device and compare it to a predicate device. This includes information on the device design, materials, intended use, and performance.
The purpose of 510(k) substantial equivalence determination is to demonstrate that a new medical device is as safe and effective as a legally marketed predicate device, without the need to conduct clinical trials if deemed substantially equivalent.
Information such as device description, intended use, technological characteristics, performance data, materials, and labeling must be reported on a 510(k) substantial equivalence determination.
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