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This document provides a summary of safety and effectiveness information supporting the marketing of the Gentian Cystatin C Immunoassay device, which is used for the quantitative determination of

How to fill out 510k summary for gentian

How to fill out 510(k) Summary for Gentian Cystatin C Immunoassay

1. Begin with the Title: Clearly label the document as '510(k) Summary'.
2. Identify the Submitter: Provide the name and address of the manufacturer.
3. Describe the Device: Summarize the Gentian Cystatin C Immunoassay including its intended use and technological characteristics.
4. Comparison with Predicate Devices: Identify legally marketed predicate devices and describe how your device is similar or different.
5. Performance Testing: Summarize any performance tests conducted, including analytic performance and clinical performance data.
6. Safety and Effectiveness: Provide evidence of safety and effectiveness, referencing relevant studies or data.
7. Supporting Documents: Include any relevant labeling, instructions for use, and standards met.
8. Conclusion: Summarize the compatibility of the Gentian Cystatin C Immunoassay with regulatory requirements.

Who needs 510(k) Summary for Gentian Cystatin C Immunoassay?

1. Manufacturers of the Gentian Cystatin C Immunoassay need a 510(k) Summary to demonstrate that their device is safe and effective for its intended use.
2. Healthcare professionals may refer to the summary to understand the device's safety and effectiveness.
3. Regulatory agencies, such as the FDA, require this summary for the evaluation of the device before it can be marketed.

People Also Ask about

What is the cystatin C reagent?

With the kidney not functioning properly, the cystatin level increases. With this test, the clinician can find GFR (Glomerular Filtration Rate). The Cystatin C test measures the level of cystatin C in the blood with the serum/plasma in 10 minutes.

What is Section 501 of the Food, Drug and Cosmetic Act?

Section 501(a)(2)(B) of the FD&C Act stipulates that a drug is considered adulterated (poorer in quality by adding another substance) if “the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with

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

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).

What does FDA 510 K clearance 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 Food, Drug and Cosmetic Act Section 510 K?

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 does it mean to be 510 K exempt?

A device may be exempt from 510(k) requirements if the FDA determines that a 510(k) is not required to provide reasonable assurance of safety and effectiveness for the device (see sections 510(l) and 510(m) of the Federal Food, Drug, and Cosmetic (FD&C) Act).

For pdfFiller’s FAQs

What is 510(k) Summary for Gentian Cystatin C Immunoassay?

The 510(k) Summary for Gentian Cystatin C Immunoassay is a document submitted to the FDA that outlines the device's intended use, technological characteristics, and clinical performance, demonstrating that it is substantially equivalent to a legally marketed device.

Who is required to file 510(k) Summary for Gentian Cystatin C Immunoassay?

The manufacturer or the representative of the manufacturer of the Gentian Cystatin C Immunoassay is required to file the 510(k) Summary with the FDA.

How to fill out 510(k) Summary for Gentian Cystatin C Immunoassay?

To fill out the 510(k) Summary, the applicant should include the device's trade name, common name, classification, intended use, labeling, descriptions of the device, performance data, substantial equivalence comparisons, and any additional information requested by the FDA.

What is the purpose of 510(k) Summary for Gentian Cystatin C Immunoassay?

The purpose of the 510(k) Summary is to provide the FDA with the necessary information to determine whether the Gentian Cystatin C Immunoassay is safe and effective for its intended use, and to establish its substantial equivalence to existing devices.

What information must be reported on 510(k) Summary for Gentian Cystatin C Immunoassay?

Information that must be reported includes the device's identification, description, labeling, summary of safety and effectiveness, details of substantial equivalence, any relevant clinical and non-clinical data, and a statement of compliance with applicable regulations.