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This document outlines the safety and effectiveness of the ADVIA Centaur® Calibrator 80 according to FDA regulations, including its intended use as an in vitro diagnostic calibrator for allergen

How to fill out 510k summary of safety

How to fill out 510(k) Summary of Safety and Effectiveness for the ADVIA Centaur® Calibrator 80

1. Begin by gathering all relevant data regarding the ADVIA Centaur® Calibrator 80.
2. Assemble information on the device description detailing its intended use and specifications.
3. Compile the summary of safety, outlining the risk assessment and management strategies.
4. Document the evidence of effectiveness, including clinical data or performance testing results.
5. Read through the FDA guidelines on 510(k) submissions to ensure compliance with required formats.
6. Fill out the specified form, ensuring all sections are complete and accurate.
7. Include any additional supporting documentation or references that strengthen your submission.
8. Review the entire 510(k) summary for clarity and completeness before final submission.
9. Submit the 510(k) summary electronically via the FDA's submission portal.

Who needs 510(k) Summary of Safety and Effectiveness for the ADVIA Centaur® Calibrator 80?

1. Manufacturers of the ADVIA Centaur® Calibrator 80 who are seeking FDA clearance for market entry.
2. Quality assurance and regulatory personnel involved in compliance and documentation.
3. Healthcare professionals who will utilize the calibrator and need to understand its safety and effectiveness.

For pdfFiller’s FAQs

What is 510(k) Summary of Safety and Effectiveness for the ADVIA Centaur® Calibrator 80?

The 510(k) Summary of Safety and Effectiveness for the ADVIA Centaur® Calibrator 80 is a document submitted to the FDA that outlines the product's safety and effectiveness, demonstrating that it is substantially equivalent to a legally marketed device. It includes information about the device's intended use, technological characteristics, and any performance testing results.

Who is required to file 510(k) Summary of Safety and Effectiveness for the ADVIA Centaur® Calibrator 80?

Manufacturers or importers of the ADVIA Centaur® Calibrator 80 are required to file the 510(k) Summary of Safety and Effectiveness, especially if they are seeking marketing clearance for a device that is not exempt from premarket notification requirements.

How to fill out 510(k) Summary of Safety and Effectiveness for the ADVIA Centaur® Calibrator 80?

To fill out the 510(k) Summary of Safety and Effectiveness for the ADVIA Centaur® Calibrator 80, one must provide details including the device's name, manufacturer information, intended use, technological characteristics, performance data, labels, and any other relevant information that supports the claims of safety and effectiveness.

What is the purpose of 510(k) Summary of Safety and Effectiveness for the ADVIA Centaur® Calibrator 80?

The purpose of the 510(k) Summary of Safety and Effectiveness for the ADVIA Centaur® Calibrator 80 is to inform the FDA and the public about the device's safety and effectiveness, facilitate regulatory review, and ensure that potentially harmful devices are not marketed without proper evaluation.

What information must be reported on 510(k) Summary of Safety and Effectiveness for the ADVIA Centaur® Calibrator 80?

The 510(k) Summary of Safety and Effectiveness for the ADVIA Centaur® Calibrator 80 must report information such as device identification, manufacturer details, comparisons to predicate devices, intended use, technological features, performance data including clinical and non-clinical testing results, and labeling information.