Get the free 510(k) Premarket Notification: FOI Glucose Control for Aviva Plus - accessdata fda

This document provides the 510(k) summary and details regarding the FDI Glucose Control Solution designed for use with Accu-Chek Aviva blood glucose meter, including its intended use, device characteristics,

How to fill out 510k premarket notification foi

How to fill out 510(k) Premarket Notification: FOI Glucose Control for Aviva Plus

1. Identify the device classification and determine if the 510(k) submission is required.
2. Collect data on the Aviva Plus's glucose control system, including performance data and testing methodologies.
3. Prepare a device description that outlines how the Aviva Plus operates and its intended use.
4. Compile labeling information, including instructions for use and advertising materials.
5. Conduct safety and effectiveness testing to establish the device's performance relative to predicate devices.
6. Complete the 510(k) submission form, ensuring all required sections are filled out accurately.
7. Include a comparison with a predicate device, demonstrating substantial equivalence.
8. Submit the completed 510(k) to the FDA along with the required fees.
9. Respond to any queries or additional information requests from the FDA during the review process.
10. Await FDA clearance before commercializing the device.

Who needs 510(k) Premarket Notification: FOI Glucose Control for Aviva Plus?

1. Manufacturers of glucose control systems that wish to market the Aviva Plus device in the United States.
2. Companies developing new versions of existing glucose monitoring devices.
3. Medical device firms seeking FDA approval for devices claiming equivalence to the Aviva Plus.

People Also Ask about

How to use Accu-Chek Aviva Control Solution?

Place the meter on a flat surface. Apply the control solution you want to test, using either Level 1 or Level 2 control solution. When you see the flashing blood drop appear on the display, squeeze the bottle until a tiny drop forms at the tip of the bottle. Touch the drop to the yellow edge of the test strip.

Is Accu-Chek Aviva Plus discontinued?

The Accu-Chek Aviva Plus meter itself has been discontinued, but the Accu-Chek Aviva Plus test strips are still available for purchase. This means that if you already own an Accu-Chek Aviva Plus meter, you can continue to use it with the corresponding test strips.

Is Accu-Chek Aviva Plus being discontinued?

The Accu-Chek Aviva Plus meter itself has been discontinued, but the Accu-Chek Aviva Plus test strips are still available for purchase. This means that if you already own an Accu-Chek Aviva Plus meter, you can continue to use it with the corresponding test strips.

What is the Accu Chek Aviva Plus meter used for?

The Roche Accu-Chek Aviva Plus is an automatic blood glucose meter. Its blood glucose measurement technology has been proven to be accurate, with a 3-star Medaval rating. Blood glucose measurements are normally taken from the finger but alternative site testing is allowed.

What is Accu-Chek Aviva Plus?

About this item Get accurate blood glucose results quickly and easily. The Aviva Plus meter stores 500 blood glucose test results plus 20 control records. The Aviva meter will soon be discontinued, though Accu-Chek Aviva Plus test strips and control solution (sold separately) will continue to be available.

Which is the best glucometer to buy in India?

List Of Best Glucometers in India BeatO CURV Glucometer FREE Strips & Lancets Type-C USB Connector Android Only. BeatO SMART Glucometer - Blood Sugar Testing Machine iOS Only With Strips & Lancets. RGB Sinocare Safe Accu 2 Blood Glucose Monitor. Dr. AccuSure Sensor Glucometer Machine with 25 Test Strips & 10 Lancets.

For pdfFiller’s FAQs

What is 510(k) Premarket Notification: FOI Glucose Control for Aviva Plus?

The 510(k) Premarket Notification for FOI Glucose Control for Aviva Plus is a submission made to the FDA to demonstrate that the Aviva Plus glucose control solution is safe and effective for its intended use, in comparison to a legally marketed predicate device.

Who is required to file 510(k) Premarket Notification: FOI Glucose Control for Aviva Plus?

Manufacturers or importers of medical devices, such as the glucose control solution intended for use with the Aviva Plus blood glucose monitoring system, are required to file a 510(k) Premarket Notification with the FDA before marketing the device.

How to fill out 510(k) Premarket Notification: FOI Glucose Control for Aviva Plus?

To fill out the 510(k) Premarket Notification for FOI Glucose Control for Aviva Plus, the applicant must complete the FDA's 510(k) form and submit necessary information including device description, intended use, labeling, and performance testing data, demonstrating safety and effectiveness.

What is the purpose of 510(k) Premarket Notification: FOI Glucose Control for Aviva Plus?

The purpose of the 510(k) Premarket Notification for FOI Glucose Control for Aviva Plus is to obtain FDA clearance to market the device by proving it is substantially equivalent to an already legally marketed device, ensuring safety and efficacy for consumers.

What information must be reported on 510(k) Premarket Notification: FOI Glucose Control for Aviva Plus?

The information that must be reported in the 510(k) Premarket Notification includes device name, intended use, device description, labeling, substantial equivalence to a predicate device, performance testing results, and any adverse event history if applicable.