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This document summarizes the 510(k) safety and effectiveness information for the ADVIA Chemistry Glucose Hexokinase_3 reagent, detailing its intended use, device description, and comparison to predicate

How to fill out 510k summary - accessdata

How to fill out 510(k) Summary

1. Identify the device and its intended use.
2. Determine if your device is substantially equivalent to a predicate device.
3. Collect information on the device design and performance.
4. Prepare a summary that includes the device description, intended use, technological characteristics, and performance data.
5. Include labeling information that describes indications for use, directions for use, and any warnings or precautions.
6. Review the 510(k) guidance documents to ensure compliance with FDA regulations.
7. Compile the necessary documentation and submit the 510(k) Summary to the FDA.

Who needs 510(k) Summary?

1. Manufacturers of medical devices that are seeking to market a new device that is substantially equivalent to an already marketed device.
2. Companies looking to modify an existing device and require FDA clearance for the changes.
3. Startups and established businesses wanting to enter the medical device market.

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 premarket notification submitted to the FDA to demonstrate that a medical device is safe and effective and is substantially equivalent to a predicate device.

Who is required to file 510(k) Summary?

Manufacturers of medical devices that are intending to market devices that are not exempt from premarket notification requirements are required to file a 510(k) Summary.

How to fill out 510(k) Summary?

To fill out a 510(k) Summary, one must include detailed information about the device, including its intended use, description, comparisons to predicate devices, testing results, and labeling.

What is the purpose of 510(k) Summary?

The purpose of the 510(k) Summary is to provide the FDA with information about a new medical device to determine if it can be marketed based on its similarity to an existing device.

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

The information that must be reported includes the device name, manufacturer details, descriptions of the device, intended use, comparison to predicate devices, and results from nonclinical and clinical tests.