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This document provides essential details regarding the substantial equivalence determination for ELITech Clinical Systems URINE TOTAL PROTEIN Standard 100 mg/dL and URINE CONTROL BI-LEVEL devices.

How to fill out 510k summary - accessdata

How to fill out 510(k) Summary

1. Identify the device you are submitting for 510(k) clearance.
2. Determine the appropriate predicate device for comparison.
3. Gather all relevant data about the device's design, components, and intended use.
4. Provide a summary of the device, including its indications for use, technological characteristics, and performance testing results.
5. Prepare a comparison table detailing how the new device is similar to the predicate device.
6. Include a discussion of any differences and how they do not raise new safety or effectiveness concerns.
7. Compile labeling information, including instructions for use and promotional materials.
8. Submit the 510(k) Summary along with the required fee to the FDA.

Who needs 510(k) Summary?

1. Manufacturers of medical devices who intend to market their products in the United States.
2. Companies seeking to make modifications to previously cleared devices.
3. Entities looking to demonstrate that their devices are substantially equivalent to an existing, legally marketed device.

People Also Ask about

What are the three types of 510k?

There are three types of 510(k) submissions: Traditional, Abbreviated, and Special. Each type has its own requirements and may be appropriate for different types of medical devices. Traditional, Special, and Abbreviated 510(k)s require the same user fee.

What is the difference between 510k de novo and PMA?

PMA submissions are intended for high-risk devices, whereas De Novo and 510(k) are suitable for lower-risk devices with suitable predicates. Choosing the right submission pathway depends on various factors, including your device's risk level, the availability of predicates, and the resources you have available.

What are the different types of 510k s?

Types of 510(k)s. If your medical device is eligible under premarket notification criteria, there are three types of 510(k)s: Traditional, Abbreviated, and Special. The FDA offers separate checklists for the Traditional, Abbreviated, and Special 510(k)s in its Refuse to Accept Policy for 510(k)s guidance document.

What are class 1, class 2, and class 3 devices?

Class I (low to moderate risk): general controls. Class II (moderate to high risk): general controls and Special Controls. Class III (high risk): general controls and Premarket Approval (PMA)

What is the 510k pathway?

Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k).

What is the purpose of a 510 K to determine?

The focus of the 510(k) process is to prove something called 'substantial equivalence'. In other words, the aim of the game is to prove to the FDA that the medical device you want to bring to market is broadly similar to another device that's already on the market, known as a predicate device.

How long does 501k approval take?

Generally, 510(k) applicants can expect submission acceptance review decisions within 15 calendar days; substantive review decisions within 60 days; and final decisions within 90 days. Applicants with outstanding review issues will be notified within 100 days.

What is the difference between 510k cleared and approved?

When a medical device is cleared, this means it has undergone a 510(k) submission, which FDA has reviewed and provided clearance. Approval: For Class III medical devices to be legally marketed they must undergo a rigorous review and approval process.

For pdfFiller’s FAQs

What is 510(k) Summary?

A 510(k) Summary is a document submitted to the FDA that provides information about a medical device's intended use and how it is substantially equivalent to a legally marketed device.

Who is required to file 510(k) Summary?

Manufacturers of medical devices that are not exempt and are seeking to market a device that is substantially equivalent to another device must file a 510(k) Summary.

How to fill out 510(k) Summary?

To fill out a 510(k) Summary, a manufacturer must provide details about the device, including its name, intended use, description, comparisons to predicate devices, performance testing, and labeling.

What is the purpose of 510(k) Summary?

The purpose of the 510(k) Summary is to demonstrate that a new medical device is as safe and effective as an existing device already approved for the market, ensuring compliance with FDA regulations.

What information must be reported on 510(k) Summary?

The 510(k) Summary must report device details such as the device name, intended use, technological characteristics, comparisons with predicate devices, and any relevant clinical and non-clinical data.