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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY AND INSTRUMENT COMBINATION TEMPLATE510(k) Number:
k162281
B. Purpose for Submission:
New Device
C. Measured:
Whole blood hemoglobin
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How to fill out 510k substantial equivalence determination
How to fill out 510k substantial equivalence determination
01
To fill out a 510k substantial equivalence determination, follow these steps:
02
Gather all the necessary documentation and information about the device you are seeking substantial equivalence for.
03
Start by completing the FDA Form 3734 - Substantial Equivalence Determination.
04
Provide the necessary details about the device, including its intended use, indications for use, and technological characteristics.
05
Describe the predicate device(s) to which you are claiming substantial equivalence and provide evidence to support your claim.
06
Include any supporting documents or test data to demonstrate and justify the substantial equivalence of your device.
07
Complete any additional sections or forms required by the FDA, such as Form FDA 3474 - Device Identifier Request.
08
Ensure that all information provided is accurate and up-to-date.
09
Submit the completed form and supporting documents to the FDA for review.
10
Await feedback and further instructions from the FDA regarding your substantial equivalence determination.
11
If requested, provide any additional information or clarification as needed during the review process.
12
Upon receiving a substantial equivalence determination from the FDA, promptly comply with any further requirements or actions specified.
13
Keep copies of all documentation and correspondence related to the 510k substantial equivalence determination for future reference.
Who needs 510k substantial equivalence determination?
01
Medical device manufacturers who intend to introduce a new device to the U.S. market that is not exempt from premarket notification requirements need to obtain a 510k substantial equivalence determination.
02
Also, manufacturers who plan to make significant modifications to an already marketed device that may affect its safety or effectiveness may also require a substantial equivalence determination.
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