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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT C O M BIN A TO N TEMPLATE. 510(k) Number: k113314 B. Purpose for Submission: New device C. Measured: Capillary, Venous

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How to fill out 510k substantial equivalence determination

01

To fill out the 510k substantial equivalence determination, follow these steps:

02

Begin by gathering all necessary information, including the product description, intended use, and technical specifications.

03

Identify the predicate device that you believe your product is substantially equivalent to.

04

Conduct research and collect data to support your claim of substantial equivalence.

05

Prepare a written report that includes a detailed comparison of your product and the predicate device, highlighting any similarities and differences.

06

Provide scientific and technical justifications for any differences between your product and the predicate device.

07

Include any test results, clinical data, or other evidence that supports your claim of substantial equivalence.

08

Prepare a summary of your findings and conclusions.

09

Submit the completed 510k substantial equivalence determination to the relevant regulatory authority for review and evaluation.

Who needs 510k substantial equivalence determination?

01

Anyone who is seeking to market a medical device in the United States that does not qualify for an exemption needs to obtain a 510k substantial equivalence determination.

02

Manufacturers, importers, and distributors of medical devices must submit a 510k application for substantial equivalence to demonstrate that their product is safe and effective.

03

This determination is required by the Food and Drug Administration (FDA) as part of the premarket notification process for most Class II medical devices.

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What is 510k substantial equivalence determination?

The 510(k) substantial equivalence determination is a process by which the FDA evaluates whether a new medical device is substantially equivalent to a legally marketed device. If it is, the new device can be marketed without the need for premarket approval.

Who is required to file 510k substantial equivalence determination?

Manufacturers of medical devices that are not exempt from premarket notification requirements and that wish to market a new device in the U.S. are required to file a 510(k) substantial equivalence determination.

How to fill out 510k substantial equivalence determination?

To fill out the 510(k) substantial equivalence determination, manufacturers must complete the 510(k) submission form, providing information about the device, its intended use, labeling, and comparisons with a similar legally marketed device.

What is the purpose of 510k substantial equivalence determination?

The purpose of the 510(k) substantial equivalence determination is to ensure that new medical devices are safe and effective by demonstrating that they are at least as safe and effective as existing devices.

What information must be reported on 510k substantial equivalence determination?

The information that must be reported includes device description, intended use, comparison to predicate devices, performance data, and labeling.

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