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This document contains the 510(k) summary for the Tina-Quant HbA1c assay Gen 3, submitted by Roche Diagnostics Corporation. It provides details for determining substantial equivalence for the device

How to fill out 510k summary - accessdata

How to fill out 510(k) Summary

1. Identify the device that requires a 510(k) submission.
2. Collect all necessary information regarding the device's intended use, specifications, and performance data.
3. Determine the appropriate predicate device to demonstrate substantial equivalence.
4. Prepare a summary of the device including description, indications for use, technological characteristics, and comparisons to the predicate device.
5. Include safety and effectiveness information, along with any relevant clinical data or scientific literature.
6. Format the summary according to FDA guidelines, ensuring all required sections are included.
7. Submit the 510(k) Summary through the FDA's electronic submission gateway.

Who needs 510(k) Summary?

1. Manufacturers of medical devices intended for commercial distribution in the U.S.
2. Companies seeking to market devices that are not exempt from 510(k) requirements.
3. Entities developing new devices that are similar to currently marketed devices.

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 and its intended use, demonstrating that it is substantially equivalent to a device already legally marketed.

Who is required to file 510(k) Summary?

Manufacturers of medical devices that are not exempt and intend to market a new device must file a 510(k) Summary with the FDA.

How to fill out 510(k) Summary?

To fill out a 510(k) Summary, include the device's name, description, intended use, substantial equivalence comparison, labeling, and any performance data required to demonstrate safety and effectiveness.

What is the purpose of 510(k) Summary?

The purpose of the 510(k) Summary is to inform the FDA and the public about the safety and effectiveness of a new medical device and to establish that it is substantially equivalent to a device already on the market.

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

The information required includes the manufacturer's name, device name, a description of the device, intended use, technological characteristics, comparison to predicate devices, and any clinical or non-clinical data supporting the submission.