Keto-Diastix Urine Test Strips

Medical Description

Keto-Diastix® is an in vitro diagnostic medical device intended for the semi-quantitative detection of glucose (glycosuria) and ketone bodies (ketonuria) in urine.

These urine test strips are used as part of diabetes management, particularly in insulin-dependent patients or those with impaired glucose control. They enable rapid identification of the presence of glucose in the urine when blood glucose levels exceed the renal threshold, as well as excessive production of ketone bodies in cases of insulin deficiency.

Diabetes is a chronic metabolic disorder characterized by persistent hyperglycemia. When the body cannot properly use glucose as an energy source, it breaks down fats, leading to the formation of ketone bodies. A significant accumulation can increase the risk of diabetic ketoacidosis, a complication requiring prompt medical attention.

Keto-Diastix® is a complementary self-monitoring tool that enables early detection of a metabolic imbalance.

Directions for Use

1. Collect a fresh urine sample in a clean, dry container or pass the test strip under the urine stream.
2. Briefly immerse the reactive area without touching the colorimetric sections.
3. Drain off any excess urine.
4. Read the results:

• Ketones: 15 seconds after immersion
• Glucose: 30 seconds after immersion

Do not interpret results beyond the recommended time frames.

It is recommended that you record the results to ensure regular monitoring.

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Pharmacist’s Advice

Urine test strips are not a substitute for capillary blood glucose monitoring. They should be used as a supplement to your regular medical care.

The Accu-Chek Guide Wireless blood glucose meter is easy to use and provides accurate results to help you better manage your diabetes.

The use of Keto-Diastix® test strips is particularly recommended:

• In cases of persistent hyperglycemia
• In the presence of infection, fever, or metabolic stress
• In cases of nausea, vomiting, or abdominal pain
• When there is an imbalance in insulin therapy

In cases of moderate or high ketonuria, it is essential to contact a healthcare professional immediately.

Store the test strips between 15°C and 30°C in their tightly sealed bottle. Do not remove the desiccant.

Regulatory Information

• In vitro diagnostic medical device
• CE Mark 2797
• Single-use
• Packaging: box of 50 test strips
• Shelf life after opening: 6 months
• Read the instructions carefully before use

Do not use after the expiration date.

Medical summary of the product

Keto-Diastix® is a medical device for self-monitoring urine to detect glucose and ketones. It helps with the early identification of blood glucose imbalances and the prevention of diabetic ketoacidosis, as a supplement to blood glucose monitoring.

Frequently Asked Questions

What are Keto-Diastix® test strips used for?

They are used to detect the presence of glucose and ketones in urine to monitor for imbalances associated with diabetes.

How long does it take to get a result?

The ketone reading takes 15 seconds, and the glucose reading takes 30 seconds.

Do the test strips replace a blood glucose meter?

No. They complement blood glucose monitoring but do not replace blood glucose testing.

What should you do if ketones are detected?

If the result is moderate or high, it is recommended that you check your blood glucose level and consult a healthcare professional.