Get the free 510(k) Summary

This document provides a comprehensive summary of the FOCUS Blood Glucose Monitoring System and FOCUS Pro Blood Glucose Monitoring System, intended for measuring glucose levels in fresh capillary whole blood and venous or arterial blood. It details the device\'s intended use for self-testing and professional use, product codes, FDA regulation information, and technological characteristics. It confirms the systems\' equivalency to a predicate device and outlines operational features, including...

How to fill out 510k summary

How to fill out 510k summary

1. Identify the device and its intended use.
2. Gather information on the device design, components, and materials.
3. Conduct a risk analysis and document any potential hazards.
4. Provide performance testing and clinical data supporting safety and efficacy.
5. Compare the device to a predicate device, highlighting similarities and differences.
6. Include labeling information and intended user instructions.
7. Ensure that all necessary forms and fees are completed.
8. Review the summary for completeness and accuracy before submission.

Who needs 510k summary?

1. Manufacturers of medical devices seeking market approval in the US.
2. Companies developing new devices that are substantially equivalent to existing ones.
3. Importers of medical devices that need to demonstrate compliance with FDA regulations.

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What is 510k summary?

The 510(k) summary is a document that provides information about a medical device that is submitted to the FDA to demonstrate that the device is safe and effective for its intended use.

Who is required to file 510k summary?

Manufacturers of medical devices that intend to market their products in the United States are required to file a 510(k) summary if their device is not significantly different from a legally marketed device.

How to fill out 510k summary?

To fill out a 510(k) summary, manufacturers must prepare a document that includes device description, intended use, comparison to predicate devices, and performance data, among other required information.

What is the purpose of 510k summary?

The purpose of the 510(k) summary is to provide the FDA with sufficient information to assess whether the medical device is safe and effective, and to ensure that it meets the regulatory requirements before it is marketed.

What information must be reported on 510k summary?

The 510(k) summary must report information such as device identification, intended use, technological characteristics, comparison to predicate devices, and summary of safety and effectiveness.