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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY AND INSTRUMENT COMBINATION TEMPLATE. 510(k) Number:
K173505
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:
02
Start by obtaining the necessary FDA forms.
03
Fill out the information required in the forms, including product details, device description, and intended use.
04
Provide information on the predicate device that the new device is being compared to.
05
Include any test data or clinical studies that support the substantial equivalence claim.
06
Submit the completed forms and supporting documents to the FDA for review.
07
Work closely with the FDA during the review process, providing any additional information or clarifications as requested.
08
Once the FDA determines substantial equivalence, you can proceed with the necessary clearance or approval processes.
Who needs 510k substantial equivalence determination?
01
Anyone who intends to market a medical device in the United States and wants to establish substantial equivalence to a legally marketed device should complete a 510k substantial equivalence determination.
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What is 510k substantial equivalence determination?
510k substantial equivalence determination is a premarket submission made to the FDA to demonstrate that a new medical device is substantially equivalent to a predicate device that is legally marketed.
Who is required to file 510k substantial equivalence determination?
Any manufacturer who intends to market a new medical device in the United States is required to file a 510k substantial equivalence determination.
How to fill out 510k substantial equivalence determination?
The process involves providing detailed information about the new medical device, comparing it to a predicate device, and submitting the application to the FDA for review.
What is the purpose of 510k substantial equivalence determination?
The purpose is to demonstrate that the new medical device is as safe and effective as a legally marketed device, thereby allowing it to be marketed in the US.
What information must be reported on 510k substantial equivalence determination?
Information such as device description, performance data, labeling, and a comparison to a predicate device must be included in the submission.
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