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This document provides a summary of Roche Diagnostics Corporation's 510(k) submission to market the Calcium Generation 2 assay, detailing device features, intended use, and substantial equivalence
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How to fill out 510(k) Summary - Calcium Generation 2 Assay
01
Gather all necessary data related to the Calcium Generation 2 Assay, including intended use, device description, and labeling.
02
Identify and summarize the predicate devices you are comparing your assay with.
03
Describe the technological characteristics of the Calcium Generation 2 Assay and how it compares to predicate devices.
04
Compile performance data, including clinical and non-clinical studies supporting the safety and effectiveness of your assay.
05
Include a summary of any adverse events, if applicable.
06
Ensure that your summary includes a declaration of compliance with relevant standards and regulations.
07
Review the draft of the summary for clarity, accuracy, and completeness before final submission.
Who needs 510(k) Summary - Calcium Generation 2 Assay?
01
Manufacturers of in vitro diagnostic devices that are utilizing the Calcium Generation 2 Assay for the assessment of calcium levels in clinical specimens.
02
Companies seeking FDA clearance to market their Calcium Generation 2 Assay.
03
Research institutions or laboratories that intend to use the Calcium Generation 2 Assay and require regulatory compliance.
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What is 510(k) Summary - Calcium Generation 2 Assay?
The 510(k) Summary - Calcium Generation 2 Assay is a document submitted to the FDA that outlines the details of a medical device's performance and its equivalence to other legally marketed devices, specifically for the measurement of calcium levels in the body.
Who is required to file 510(k) Summary - Calcium Generation 2 Assay?
Manufacturers of medical devices that are seeking marketing clearance for the Calcium Generation 2 Assay must file a 510(k) Summary with the FDA.
How to fill out 510(k) Summary - Calcium Generation 2 Assay?
To fill out the 510(k) Summary for the Calcium Generation 2 Assay, manufacturers should provide detailed information about the device, including its intended use, technological characteristics, a description of the testing conducted, and evidence of substantial equivalence to predicate devices.
What is the purpose of 510(k) Summary - Calcium Generation 2 Assay?
The purpose of the 510(k) Summary for the Calcium Generation 2 Assay is to demonstrate to the FDA that the device is safe and effective for its intended use, and that it is substantially equivalent to other existing devices on the market.
What information must be reported on 510(k) Summary - Calcium Generation 2 Assay?
The information that must be reported includes the device's name, classification, intended use, description of the device, comparisons to predicate devices, performance testing results, labeling, and any other relevant documentation that supports the substantial equivalence claim.
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