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This document summarizes the 510(k) safety and effectiveness information for the HE4 EIA Control Replacement, intended for in vitro diagnostic use in monitoring ovarian cancer.

How to fill out premarket notification 510k he4

How to fill out Premarket Notification (510(k)) HE4 EIA Control Replacement

1. Gather the necessary documentation, including the device description and intended use.
2. Review the 510(k) submission guidelines provided by the FDA.
3. Complete the manufacturer's information section accurately.
4. Describe the HE4 EIA Control Replacement and its technological characteristics.
5. Include performance testing data and relevant clinical studies to support safety and effectiveness.
6. Compile a detailed comparison with the predicate device, highlighting similarities and differences.
7. Assemble labeling information and instructions for use, ensuring compliance with FDA regulations.
8. Submit the completed 510(k) form along with the required fees to the FDA.

Who needs Premarket Notification (510(k)) HE4 EIA Control Replacement?

1. Manufacturers of in vitro diagnostic devices that require market clearance for the HE4 EIA Control Replacement.

People Also Ask about

What is a 510 K premarket notification?

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).

How long does it take for the 510 K determination in the case of traditional premarket notification?

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 an exemption from the 510k premarket notification requirements?

Most class I and class II devices are exempt from 510(k) requirements. Devices that may be 510(k) exempt include: Preamendment devices (devices legally marketed in the US prior to May 28, 1976) Class I devices specifically exempted by FDA or classified as class I under section 513 (with certain exceptions)

What is the Section 510 K of the Federal Food, Drug and Cosmetic Act?

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 is premarket notification 510k?

A 510(k) Premarket Notification is required for low to moderate risk medical devices classified as either Class I or Class II and not exempt from 510(k). Companies are unable to market their products to health care providers, patients and other consumers until they are given 510(k) clearance by the FDA.

What is the meaning of premarket approval?

Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.

How do you determine if a medical device would require a 510 K approval instead of PMA?

A 510(k) is a premarket submission made to the FDA. It is called a 510(k) because it refers to that section of the Food, Drug and Cosmetic Act. It is the regulatory pathway mostly utilized for Class II devices that hope to be substantially equivalent to another device which is currently legally marketed.

For pdfFiller’s FAQs

What is Premarket Notification (510(k)) HE4 EIA Control Replacement?

The Premarket Notification (510(k)) HE4 EIA Control Replacement refers to the submission process for a new device that demonstrates that it is substantially equivalent to a legally marketed device. This is specific to the HE4 enzyme immunoassay control replacement in the context of medical devices.

Who is required to file Premarket Notification (510(k)) HE4 EIA Control Replacement?

Manufacturers of medical devices that are new to the market and seek to demonstrate that their device is substantially equivalent to an existing device must file a Premarket Notification (510(k)) HE4 EIA Control Replacement.

How to fill out Premarket Notification (510(k)) HE4 EIA Control Replacement?

Filling out a Premarket Notification (510(k)) HE4 EIA Control Replacement involves completing the FDA's 510(k) submission form, providing a description of the device, indicating its intended use, including labeling information, and providing data that supports the claim of substantial equivalence to a predicate device.

What is the purpose of Premarket Notification (510(k)) HE4 EIA Control Replacement?

The purpose of the Premarket Notification (510(k)) HE4 EIA Control Replacement is to ensure that new medical devices are safe and effective for their intended use by requiring manufacturers to provide evidence of substantial equivalence to existing devices.

What information must be reported on Premarket Notification (510(k)) HE4 EIA Control Replacement?

Information that must be reported includes the device's name, intended use, detailed description, substantial equivalence justification, safety and effectiveness data, labeling, and any prior submissions related to the device.