What is In Vitro Diagnostic (IVD) eSTAR for 510k Submission?

In Vitro Diagnostic (IVD) eSTAR is a standardized electronic Submission Template And Resource designed to streamline the submission process for in vitro diagnostic devices to the U.S. FDA (Food and Drug Administration). This template provides a structured format for submitting necessary information, which helps ensure that the Submission is comprehensive, organized, and compliant with regulatory requirements.

Example of IVD eSTAR

Suppose a company has developed a new diagnostic test kit for detecting a specific virus, such as SARS-CoV-2 (the virus responsible for COVID-19). The company must obtain U.S. FDA clearance to market this test kit in the United States. The submission process involves providing detailed information about the test kit, including its design, manufacturing, and clinical data demonstrating its accuracy and reliability.

Using the IVD eSTAR template, the company would:

1. Product Description: Provide a detailed description of the diagnostic test kit, including its intended use, the biological marker it detects, and the technological principles behind the test.
2. Analytical Performance: Submit data from analytical performance tests, such as sensitivity, specificity, accuracy, precision, and detection limit. This ensures the test kit can reliably detect the virus.
3. Clinical Performance: Include clinical performance data demonstrating how well the test kit performs in real-world settings. This might involve clinical studies comparing the test kit to a gold standard or other established diagnostic methods.
4. Reagents and Materials: Provide detailed information about the reagents and materials used in the test kit, including their sources, quality control measures, and stability data.
5. Labeling: Include copies of the device labeling, such as instructions for use, warnings, contraindications, and other relevant information for users.
6. Quality System Information: Submit information about the manufacturing process, quality control measures, and compliance with relevant standards, such as Good Manufacturing Practices (GMP).
7. Software Documentation: If the test kit includes software (e.g., for analyzing test results), provide documentation and testing data to demonstrate that the software is reliable and performs correctly.

The IVD eSTAR template organizes these sections in a standardized format, making it easier for both the submitter and the FDA to review and process the Submission efficiently.

In summary, the IVD eSTAR is a supportive tool that ensures that regulatory submissions, such as 510k submissions for in vitro diagnostic devices, are comprehensive, organized, and compliant with FDA requirements. This support facilitates the review process and reassures companies of the timely approval of new diagnostic technologies.