Get 510(k) Substantial Equivalence Determination Decision Memorandum Assay And Instrument Combination

Filling out the 510(k) substantial equivalence determination decision memorandum assay and instrument combination online can be a straightforward process if you follow the correct steps. This guide provides clear, user-friendly instructions to assist you in completing the form accurately.

Follow the steps to successfully complete your submission.

1. Click ‘Get Form’ button to access the form and open it in your editing software.
2. In the '510(k) Number' section, enter the appropriate identification number, such as 'k182593', for your device.
3. Provide the 'Purpose for Submission' by indicating whether it is for a new device.
4. Fill in the 'Measurand' field by stating the substance being tested, for example, 'β-Ketone, as beta-hydroxybutyrate, in fingertip capillary whole blood'.
5. Specify the 'Type of Test' to be conducted, which is 'Quantitative amperometry' in this case.
6. Enter the information for 'Applicant', including the name of the organization, for instance, 'Apex Biotechnology Corp.'.
7. Complete the 'Proprietary and Established Names' section with the product name, such as 'KET-1 Blood Ketone Monitoring System'.
8. In the 'Regulatory Information' section, accurately fill in regulation details including section number, classification, and product code.
9. Describe the 'Intended Use' and 'Indication(s) for Use', ensuring clarity that it is for self-testing for people with diabetes at home.
10. List any special conditions for use, referencing any limitations or precautions users must be aware of.
11. Detail the 'Device Description' comprehensively, including components of the device and any necessary specifications.
12. In 'Substantial Equivalence Information', outline the predicate device and its comparison to establish substantial equivalence.
13. Review and summarize all additional supportive information and performance characteristics required by the form.
14. Once all fields are filled in, ensure that all information is accurate and complete before proceeding.
15. Finally, save your changes, download the form, print it out, or share it as necessary for submission.

Start filling out your 510(k) substantial equivalence determination decision memorandum online today for a smooth submission process.