FORA 6 Blood Glucose Test Strips

Warnings

• For in vitro diagnostic use (for use outside of the body only).
• For single use only.
• Healthcare professionals and other users testing multiple patients should handle all items that have come into contact with human blood carefully to prevent transmitting infectious diseases.
• Read this sheet and your FORA 6 Plus / FORA 6 Connect Multi-functional meter and FORA 6 Smart blood glucose meter Owner’s Manual before using the test strips.
• Use only FORA 6 blood glucose test strips with FORA 6 Plus / FORA 6 Connect Multi-functional meter and FORA 6 Smart blood glucose meter for accurate results and warranty coverage.
• Results may be inaccurate for patients with abnormally low blood pressure or those in shock.
• Do not use the FORA 6 Plus / FORA 6 Connect Multi-functional monitoring system and FORA 6 Smart Blood Glucose monitoring system on critically ill patients. In cases of extreme hyperglycemia (over 600 mg/dL or 33.3 mmol/L), capillary blood collection from approved sample sites is not advised if peripheral circulation is impaired, as the physiological blood glucose level may not be a true reflection. This can occur in severe dehydration due to diabetic ketoacidosis or stress hyperglycemia, hyperosmolar non-ketotic coma, shock, decompensated heart failure (NYHA Class IV), or peripheral arterial occlusive disease.
• Keep test strips and lancets away from small children. If swallowed, consult a doctor immediately.

Intended Use

The FORA 6 blood glucose test strip, used with the FORA 6 Plus / FORA 6 Connect Multi-functional meter and FORA 6 Smart blood glucose meter, allows for self-monitoring of blood glucose levels at home or by healthcare professionals. It uses fresh whole blood samples from the fingertip and alternative sites such as the palm, forearm, and upper arm. This system is not intended for the diagnosis or screening of diabetes mellitus.

Professionals may test with capillary and venous blood samples; home use is limited to capillary whole blood testing. Use ONLY heparin for anticoagulation of whole blood samples. Do NOT use EDTA for anticoagulation.

Limitations

• Hematocrit: The hematocrit level is limited to between 0% and 70%. Consult your healthcare professional if you do not know your hematocrit level.
• Neonatal Use: This test strip can be used for testing newborns.
• Altitude Effects: Altitudes up to 3,275 m (10,742 ft) do not affect test results.
• Do not test blood glucose during or soon after a xylose absorption test, as xylose in the blood can produce elevated glucose results.
• Refer to the appendix for a summary of substances and concentrations with interference.

Storage and Handling

• Use each test strip immediately after removing it from the vial. Close the vial immediately after taking out a strip.
• IMPORTANT: Do not use the test strips if they have expired.
• Keep the vial closed at all times.
• Store the test strips in their original vial ONLY. Do not transfer them to a new vial or any other containers.
• Do not touch the test strips with wet hands.
• Do not bend, cut, or alter the test strip.
• Store the test strips in a cool, dry place between 2°C and 30°C (35.6°F and 86°F) and below 85% relative humidity.
• Keep the test strips away from direct sunlight. Do not store the test strips in high humidity.

Testing Your Blood Glucose

PLEASE WASH AND DRY YOUR HANDS BEFORE PERFORMING ANY TESTS.

The used lancet and test strip are potentially biohazardous. Please dispose of them carefully according to your local regulations.

Please refer to your Owner’s Manual for more information.

Reading Your Result

Your blood glucose readings deliver plasma equivalent results and are displayed in mg/dL or mmol/L.

Reference Values

Please consult your doctor to determine a target range that works best for you.

Questionable or Inconsistent Results

If your test results are unusual or inconsistent with how you are feeling:

• Make sure the confirmation window of the test strip is completely filled with blood.
• Check the expiry date of the test strips.
• Check the performance of your meter and test strip with the control solutions.

Please Note: Unusually high or low blood glucose levels may be symptoms of a serious medical condition. If most of your results are unusually high or low, please contact your healthcare professional.

Quality Control Testing

Our control solutions contain a known amount of glucose that reacts with the test strips. You can check the performance of the meter, test strip, and your testing technique by comparing the control solution results with the range printed on the test strip vial label. Regular checks can ensure accurate test results. Please refer to the Owner’s Manual for complete testing instructions.

IMPORTANT: The reference range of the control solutions may vary with each new test strip vial. Make sure you check the range on the label of the vial or individual foil pack of your current test strip.

Chemical Components

• Glucose dehydrogenase (E. coli) 8%
• Enzyme protector 8%
• Electron shuttle 55%
• Non-reactive ingredients 29%

Accuracy

The following tables show the accuracy results of the FORA 6 system compared to reference methods, based on studies conducted according to EN ISO 15197:2015 standards.

Table 1: Accuracy results for glucose concentration < 100 mg/dL (5.55 mmol/L)

Table 2: Accuracy results for glucose concentration ≥ 100 mg/dL (5.55 mmol/L)

Table 3: Accuracy results for glucose concentrations between 40 mg/dL (2.22 mmol/L) to 456 mg/dL (25.3 mmol/L)

Note: According to the accuracy criteria of EN ISO 15197: 2015, 95% of all differences in glucose values should be within ±15 mg/dL (0.83 mmol/L) for glucose concentration < 100 mg/dL (5.55 mmol/L), and within ±15% for glucose concentration ≥ 100 mg/dL (5.55 mmol/L).

Additional Information for Healthcare Professionals

Always wear gloves and follow your facility’s biohazard control policy and procedures when performing tests involving patient blood samples. Use fresh whole blood samples only. Professionals may use test strips to test capillary and venous whole blood.

• Sample Size: 0.5 μL
• Reaction Time: 5 seconds
• System Measurement Range: 10 mg/dL to 600 mg/dL
• Hematocrit Range: 0% to 70%

Symbols and References

The following symbols are used on the product packaging and in this manual:

• In vitro diagnostic medical device (Symbol: A diagnostic device for use outside the body)
• Do not reuse (Symbol: A crossed-out circle with a '2' inside)
• Consult instructions for use (Symbol: A book)
• Temperature limitation (Symbol: A thermometer with temperature range)
• Use by (Symbol: A calendar icon with a date)
• Keep Dry (Symbol: An umbrella with rain drops crossed out)
• Keep away from sunlight (Symbol: A sun with rays crossed out)
• CE mark (Symbol: CE logo)
• Batch code (Symbol: 'LOT' followed by a code)
• Humidity limitation (Symbol: A droplet with a percentage)
• Do not use if package is damaged (Symbol: A package with an exclamation mark)
• Manufacturer (Symbol: Company logo or name)

References:

• [1] McEnroe, J Robert, et al. Interference testing in clinical chemistry; Approved Guideline – 2nd edition. NCCLS : 2005 - EP7-A2.
• [2] EN ISO 15197: 2015 (E): In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus, Second edition.
• [3] Hardman JG, Limbird LE, Molinoff PB, et al. Goodman & Gilman’s the Pharmacological Basis of Therapeutics. 9th ed. New York, NY: McGraw-Hill; 1996.
• [4] Zaloga GP, Macgregor D. The Critical Care Drug Handbook. 2nd ed. St Louis, MO: Mosby-Year Book; 1997.
• [5] Kost GJ, Vu HT, Lee JH, et al. Multicenter study of oxygen-intensive handheld glucose point-of-care testing in critical care/hospital/ambulatory patients in the United States and Canada. Crit Care Med. 1998;26:581-590.
• [6] Institut für Diabetes Technologie. System accuracy evaluation of FORA 6 Connect Multi-functional Monitoring System based on ISO 15197:2013 & EN ISO 15197:2015. Project No.: IDT-1739(2A)-FS; 2018