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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARYK163569A. 510(k) Number:B. Purpose for Submission: Adding a previously cleared assay on a new instrument platform C. Measured:IGM antibodies

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How to fill out 510k substantial equivalence determination

01

Step 1: Gather all necessary information about the medical device.

02

Step 2: Prepare a comprehensive summary of the device, including its intended use and technological characteristics.

03

Step 3: Identify a predicate device that is currently legally marketed in the United States and is substantially equivalent to your device.

04

Step 4: Compare your device to the predicate device in terms of intended use, technological characteristics, and performance requirements.

05

Step 5: Prepare a summary of the similarities and differences between your device and the predicate device.

06

Step 6: Evaluate and document the scientific evidence supporting the substantial equivalence of your device to the predicate device.

07

Step 7: Submit the 510(k) substantial equivalence determination to the appropriate regulatory authority, along with all required documentation and fees.

08

Step 8: Respond to any requests for additional information or clarification from the regulatory authority.

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Step 9: Await the regulatory authority's decision on the substantial equivalence determination.

Who needs 510k substantial equivalence determination?

01

Manufacturers or distributors of medical devices that are new and do not fall within the exemption criteria specified by the regulatory authority.

02

Manufacturers or distributors of medical devices that have undergone significant changes compared to their legally marketed predicate devices.

03

Manufacturers or distributors seeking to introduce a medical device into the market that has different technological characteristics or intended use than a legally marketed predicate device.

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What is 510k substantial equivalence determination?

The 510(k) substantial equivalence determination is a premarket submission made to FDA to demonstrate that a medical device is substantially equivalent to a legally marketed device.

Who is required to file 510k substantial equivalence determination?

Manufacturers of medical devices are required to file a 510(k) substantial equivalence determination.

How to fill out 510k substantial equivalence determination?

To fill out a 510(k) substantial equivalence determination, manufacturers must provide detailed information about the device, its intended use, and comparisons to similar devices already on the market.

What is the purpose of 510k substantial equivalence determination?

The purpose of a 510(k) substantial equivalence determination is to demonstrate that a new medical device is as safe and effective as a legally marketed device that is already on the market.

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

Information such as device description, intended use, technological characteristics, performance data, and a comparison to a legally marketed device must be reported on a 510(k) substantial equivalence determination.

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