Get the free 510(k) Summary for ARCHITECT Cortisol Assay - accessdata fda
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This document provides a summary of safety and effectiveness information regarding the ARCHITECT Cortisol assay, intended for the quantitative determination of cortisol in human samples as an aid
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How to fill out 510k summary for architect
How to fill out 510(k) Summary for ARCHITECT Cortisol Assay
01
Gather basic information about the ARCHITECT Cortisol Assay, including its intended use and classification.
02
Provide a description of the device, including its components, design, and function.
03
Outline the proposed indications for use.
04
Include information on performance testing, including both analytical and clinical performance data.
05
Describe the comparison with any predicate device that has been previously cleared.
06
Summarize the safety and effectiveness of the device based on your data.
07
Compile a bibliography of references and relevant studies that support the submission.
08
Ensure the summary is clear, concise, and follows the FDA's specific formatting requirements.
Who needs 510(k) Summary for ARCHITECT Cortisol Assay?
01
Manufacturers of the ARCHITECT Cortisol Assay who wish to market the device in the United States.
02
Regulatory affairs professionals working for companies that develop or sell diagnostic assays.
03
Healthcare providers and labs intending to utilize the ARCHITECT Cortisol Assay may also benefit from understanding the 510(k) process.
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What is 510(k) Summary for ARCHITECT Cortisol Assay?
The 510(k) Summary for ARCHITECT Cortisol Assay is a document submitted to the Food and Drug Administration (FDA) that provides evidence that the device is as safe and effective as a legally marketed predicate device. It includes a description of the assay, its intended use, and data supporting its performance.
Who is required to file 510(k) Summary for ARCHITECT Cortisol Assay?
The manufacturer or sponsor of the ARCHITECT Cortisol Assay is required to file the 510(k) Summary with the FDA to obtain clearance to market the device in the United States.
How to fill out 510(k) Summary for ARCHITECT Cortisol Assay?
To fill out the 510(k) Summary for the ARCHITECT Cortisol Assay, the submitter must provide detailed information including device description, intended use, performance testing results, and labeling information, following the FDA guidelines outlined in their 510(k) submission process.
What is the purpose of 510(k) Summary for ARCHITECT Cortisol Assay?
The purpose of the 510(k) Summary for ARCHITECT Cortisol Assay is to demonstrate to the FDA that the assay is safe for its intended use, effectively identifies cortisol levels, and is comparable to an existing, legally marketed device.
What information must be reported on 510(k) Summary for ARCHITECT Cortisol Assay?
The 510(k) Summary must include information such as the device's name, classification, intended use, description of the technology, performance data (including clinical and analytical validation), labeling, and comparison with predicate devices.
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