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This document is a 510(k) premarket notification summary for the IMMULITE® 2000 Syphilis Screen, detailing its intended use, device description, substantial equivalence to another assay, and regulatory

How to fill out 510k summary as required

How to fill out 510(k) Summary as Required by 21 CFR 807.92

1. Identify the device and its intended use.
2. Provide a description of the device, including operation and design features.
3. Summarize the technological characteristics of the device.
4. Explain how the device is similar to or different from a legally marketed device (predicate).
5. Include nonclinical and clinical data, if applicable, to support the safety and effectiveness.
6. Describe the conclusions drawn from the performance testing.
7. List any labeling information for the device.
8. Provide details on the manufacturing process and quality control measures.

Who needs 510(k) Summary as Required by 21 CFR 807.92?

1. Manufacturers of medical devices that are seeking to market their products in the U.S.
2. Companies that need to demonstrate that their device is substantially equivalent to an already marketed device.
3. Businesses looking to obtain FDA clearance for a new or modified medical device.

People Also Ask about

What does FDA 510k cleared mean?

The 510(k) clearance process involves a comprehensive review of safety and performance data for the device, which may include scientific, non-clinical, and clinical data, as appropriate, to determine if a new device is substantially equivalent to a device that is already on the market (that is, a predicate device).

What is required for 510k submission?

Device classes & premarket requirements that determine 510k vs PMA Class I: These devices are simple, with minimal risk to the user. Class II: Devices in this class pose a moderate level of risk to the user, and all of them require a premarket notification (510k submission) before they can be legally marketed.

What does FDA granted 510 K clearance mean?

The documentation must include drawings, schematics, and a description of the device's intended use and performance. Selection of the most appropriate predicate device — The 510(k) submission must include a comparison of the device under consideration to a predicate device already on the market.

What is FDA 510k certification?

A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval. Learn more Search Database. Help Download Files. 510K

What is the 510k summary?

The 510(k) clearance process involves a comprehensive review of safety and performance data for the device, which may include scientific, non-clinical, and clinical data, as appropriate, to determine if a new device is substantially equivalent to a device that is already on the market (that is, a predicate device).

What happens after 510k approval?

Once a device receives clearance, a company has 30 days to register the device with the FDA. If the company is new and has no devices on the market, it must also register as an establishment with the FDA, which incurs an annual fee. Some firms are surprised to learn that additional fees are involved in this process.

What is the difference between FDA and FDA 510k?

The Function Of FDA And FDA 510k? The FDA develops rules and criteria for certifying items such as medical devices, medicines, and biological substances to assure their safety for the general population. The FDA 510k must be implemented for healthcare products designated as class 2 or certain class 1 technologies.

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What is 510(k) Summary as Required by 21 CFR 807.92?

The 510(k) Summary is a document submitted to the Food and Drug Administration (FDA) that provides an overview of a medical device's safety and effectiveness, demonstrating that the device is substantially equivalent to a legally marketed device.

Who is required to file 510(k) Summary as Required by 21 CFR 807.92?

Manufacturers of medical devices that are not exempt from the premarket notification requirements are required to file a 510(k) Summary. This typically includes companies seeking to market a device in the U.S. that has not previously been cleared or approved.

How to fill out 510(k) Summary as Required by 21 CFR 807.92?

To fill out a 510(k) Summary, the manufacturer must provide specific information such as identification of the device, intended use, description of the device, comparison to predicates, data demonstrating substantial equivalence, and labeling details. The summary should be concise and comprehensible.

What is the purpose of 510(k) Summary as Required by 21 CFR 807.92?

The purpose of the 510(k) Summary is to provide the FDA and the public with information about the device's intended use, design, and substantial equivalence to existing devices in order to ensure safety and effectiveness prior to marketing.

What information must be reported on 510(k) Summary as Required by 21 CFR 807.92?

The 510(k) Summary must include the name and address of the submitter, device identification information, intended use, description of the device, assessment of the device's predicates, summary of non-clinical and clinical studies, and labeling information.