On Call Sure Sync

Blood Glucose Test Strips: Each test strip has reactive and non-reactive chemicals. These chemicals are: FAD-dependent Glucose Dehydrogenase <25 IU, Mediator <300 μg, Buffer, and Non-reactive Ingredient.
Each test strip vial contains a drying agent.
Glucose Control Solution: Control Solution 0 contains less than 0.1% glucose (active ingredient), Control Solution 1 contains less than 0.2% glucose (active ingredient) and Control Solution 2 contains less than 0.4% glucose (active ingredient), all with preservatives in an aqueous based mixture.

Performance Characteristics: Blood Glucose Test Strips: The On Call Sure and On Call Sure Sync Blood Glucose Monitoring System and On Call GU Dual Blood Glucose & Uric Acid Monitoring System comply with the requirements of EN ISO 15197:2015/ISO 15197:2013 (In vitro diagnostic test systems - requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus). The On Call Sure meter, On Call Sure Sync meter and On Call GU Dual Blood Glucose & Uric Acid Meter are calibrated by using YSI (Model 2300 STAT PLUS) Glucose Analyzer reference instrument, which is traceable to NIST reference standard.
Repeatability Precision: Ten replicate assays were each run on ten On Call Sure Sync Blood Glucose Meters. Heparinized venous blood samples at five concentration levels were used in the testing. The results provided the following estimates for reproducibility, precision. (See Table 1.)

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Intermediate Precision: Ten replicate assays drawn from three strip lots were run on ten On Call Sure Sync Blood Glucose Meters. These tests were run each day for a total of ten days. Control solutions at three concentration levels were used in the testing. The results provided the following precision estimates. (See Table 2.)

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System Accuracy: A trained technician tested the capillary blood using the On Call Sure Sync Blood Glucose Meter (y). The blood samples were from more than 100 participants. Capillary blood samples were taken from fingertip, palm and forearm. Fingertip samples from the same subjects were also analyzed with YSI Model 2300 STAT PLUS Glucose Analyzer (x). The results were compared. (See Table 3.)

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Fingertip samples were used for YSI reference measurement.
The sample range was 1.1 to 29.6 mmol/L (19.6 to 534 mg/dL) for On Call Sure Sync Blood Glucose Meter testing with blood sampled from fingertip sites. The sample range was 3.2 to 21.3 mmol/L (57 to 384 mg/dL) for On Call Sure Sync Blood Glucose Meter testing with blood sampled from palm and forearm sites. (See Table 4.)

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System accuracy according to EN ISO 15197:2015/ISO 15197:2013, >99% of measured glucose values fall within the minimum acceptable performance criteria.
Consumer Study: A consumer study was performed by testing one test strip lot. Participants used the On Call Sure Sync Blood Glucose Monitoring System. This study showed that the patient can run the test properly. (See Table 5.)

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The study evaluating glucose values from fingertip capillary blood samples obtained by 100 lay persons showed the following results: 100% within ±0.83 mmol/L (±15 mg/dL) of the medical laboratory values at glucose concentrations below 5.55 mmol/L (100 mg/dL), and 100% within ±15% of the medical laboratory values at glucose concentrations at or above 5.55 mmol/L (100 mg/dL).
Venous Study: The venous blood glucose measurements from more than 103 participants were taken by a trained technician using the On Call Sure Sync Blood Glucose Meter (y). The venous blood sample from the same subjects were also analyzed with YSI Model 2300 STAT PLUS Glucose Analyzer (x). The results were compared in the table as follows. (See Table 6.)

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Neonatal Study: The neonatal blood glucose measurements from 59 participants were taken by a trained technician using the On Call Sure Sync Blood Glucose Meter (y). The neonatal blood samples from the same subjects were also analyzed with YSI Model 2300 STAT PLUS Glucose Analyzer (x). The results were compared in the table as follows. (See Table 7.)

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For complete instructions, refer to the On Call Sure or On Call Sure Sync Blood Glucose Monitoring System or On Call GU Dual Blood Glucose & Uric Acid Monitoring System User's manual. For additional questions or issues with this product, contact the dealer for help.

Blood Glucose Test Strips: The On Call Sure Blood Glucose Test Strips are thin strips with a chemical reagent system. They work with the On Call Sure Blood Glucose Meter, On Call Sure Sync Blood Glucose Meter and On Call GU Dual Blood Glucose & Uric Acid Meter to measure the glucose concentration in whole blood. Blood is applied to the end tip of the test strip. The blood is then automatically absorbed into the reaction cell where the reaction takes place. A transient electrical current is formed during the reaction which is detected by the meter. The blood glucose concentration is then calculated based on the electrical current. The result is then shown on the meter display. The meters are calibrated to display plasma equivalent results per the recommendation of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC).
For in vitro diagnostic use. Test strips are to be used only outside the body for testing purposes.
For self-testing and professional use. On Call Sure Test Strips are used by people with diabetes at home and by healthcare professionals for the quantitative measurement of glucose in capillary whole blood from the finger, forearm, and palm. It is also used as an aid in monitoring the effectiveness of diabetes control programs. Professionals may also test neonatal, arterial and venous blood samples.
Glucose Control Solution: The On Call Sure Control Solution contains a known concentration of glucose. It is used to confirm that the On Call Sure Test Strips are working properly when used with On Call Sure Blood Glucose Meter, On Call Sure Sync Blood Glucose Meter or On Call GU Dual Blood Glucose & Uric Acid Meter and to confirm that the patient is performing the test correctly.
The patient should perform a quality control test: Before the first use of the meter to familiarize with its operation.
Before using a new vial of test strips.
When the patient suspects that the meter or test strips are not working properly.
When the patient suspects that the test results are inaccurate, or if they are inconsistent with how the they feel.
If the patient suspects that the meter is damaged.
At least once a week.
After cleaning the meter.
Three levels of control solution are available labeled Control Solution 0, Control Solution 1 and Control Solution 2. Control Solution 1 is sufficient for most all self-testing needs. If the patient thinks that the meter or strips may not be working correctly, the patient may also want to do Control Solution 0 or Control Solution 2 tests.

Blood Glucose Test Strips: For in vitro diagnostic use. The test strips are to be used only outside the body for testing purposes.
Do not use test strips after the expiration date that is shown on the vial. Expired test strips may give incorrect blood glucose readings.
Do not use test strips that are torn, bent, or damaged in any way.
Do not reuse test strips.
The sample must only be applied to the tip of the test strip. Do not apply blood or control solution to the top of the test strip as this may result in an inaccurate reading.
Discard the vial and any unused strips 18 months after the patient first opens it. Constant exposure to air may destroy chemicals in the test strip. This damage can cause incorrect readings.
Keep the test strip vial away from children and animals.
Consult a healthcare professional before making any changes in the treatment plan.
Dispose of blood samples and materials carefully. Treat all blood samples as if they are infectious materials. Follow proper precautions when disposing of materials.
Limitations: The On Call Sure meters, On Call Sure Sync meters, On Call GU Dual Blood Glucose & Uric Acid meters, On Call Sure test strips and other components of the On Call Sure and On Call Sure Sync Blood Glucose Monitoring System and On Call GU Dual Blood Glucose & Uric Acid Monitoring System have been designed, tested and proven to work together effectively to provide accurate blood glucose measurements. Do not use components from other brands.
The On Call Sure Test Strips are for testing fresh capillary, venous, arterial or neonatal whole blood. Do not use with serum or plasma samples.
The venous, arterial and neonatal blood must be obtained and tested by healthcare professionals.
Blood glucose measurement with venous or arterial whole blood samples must be performed within 15 minutes of sample collection.
Anticoagulant preservatives such as heparin or EDTA are recommended for best results in using venous or arterial whole blood samples. Use of anticoagulants such as iodoacetate, sodium citrate, or those containing fluoride is not advised.
Very high (above 70%) and very low (below 10%) hematocrit levels can cause false results. Talk to a healthcare professional to find out the hematocrit level.
Abnormally high levels of Vitamin C or other reducing substances will produce false high blood glucose measurements.
Do not use during or soon after xylose absorption testing. Xylose in the blood will cause an interference.
The system is tested to accurately read the measurement of glucose in whole blood within the range of 0.6-33.3 mmol/L (10 to 600 mg/dL).
Fats (Triglycerides up to 3,000 mg/dL or Cholesterol up to 500 mg/dL) have no major effect on blood glucose test results.
The On Call Sure and On Call Sure Sync Blood Glucose Monitoring System and On Call GU Dual Blood Glucose & Uric Acid Monitoring System shows to work properly in studies at altitudes up to 10,000 ft (3,048 meters).
Severely ill persons should not run the glucose test with the On Call Sure and On Call Sure Sync Blood Glucose Monitoring System and On Call GU Dual Blood Glucose & Uric Acid Monitoring System.
Blood samples from patients in shock, or with severe dehydration or from patients in a hyperosmolar state (with or without ketosis) have not been tested and are not recommended for testing with On Call Sure and On Call Sure Sync Blood Glucose Monitoring System and On Call GU Dual Blood Glucose & Uric Acid Monitoring System.
Glucose Control Solution: For in vitro diagnostic use. The control solution is for testing only outside the body. Do not swallow or inject. For self-testing and professional use.
Shake well before using.
Control solution tests are specified to be accurate only when tested between 10 and 40°C (50-104°F).
The control ranges shown on the test strip vial are not a recommended range for the blood glucose level. The personal blood glucose target ranges should be determined by a diabetes healthcare professional.
Do not touch the end of the test strip to the control solution bottle. This could cause contaminants to enter the control solution bottle.
Use only On Call Sure brand control solution with the On Call Sure meter, On Call Sure Sync meter or On Call GU Dual Blood Glucose & Uric Acid Meter and On Call Sure Test Strips.

Storage and Handling: Blood Glucose Test Strips: Test strips should be stored in their protective vial. The vial's cap must be tightly closed to keep the test strips in good working condition.
Store test strips in a cool, dry place at room temperature, 2-35°C (36-95°F). Store them away from heat and direct sunlight.
Do not freeze or refrigerate.
To ensure accurate results, use the test strips at room temperature.
Keep the text side up and blank side down when inserting the strip contact bars into the strip port.
Do not store or use the test strips in a humid place such as a bathroom.
Do not store the meter, the test strips or control solution near bleaches or cleaners that contain bleaches.
Do not transfer the test strips to a new vial or any other container.
Repeated insertion and removal of a test strip into the meter strip port may result in reading errors.
Replace the vial cap immediately after removing a test strip.
Use the test strip immediately after removing it from the vial.
Do not use the test strips past the unopened expiration date printed on the vial. Using test strips past the expiration date may produce incorrect test results.
Note: All expiration dates are printed in Year-Month-Date format.
A new vial of test strips may be used for 18 months after first being opened. Write the opened vial expiration date on the vial label after opening.
Glucose Control Solution: Store the control solution at room temperature, 2-35°C (36-95 °F).
Do not refrigerate or freeze.
If the control solution is cold, do not use until it has warmed to room temperature.
Use before the unopened expiration date that is shown on the bottle.
Note: All expiration dates are printed in Year-Month-Date format.
Each bottle of control solution can be used for 6 months after the patient first opens it. Record this opened expiration date on the bottle label.

Instructions for Use: Blood Glucose Test Strips: See your User's Manual for complete instructions for blood sample collection before use.
1. Open the cap of the test strip vial only to remove a test strip for testing. Replace the cap immediately to protect the remaining test strips from moisture in the air.
2. Run the blood glucose test following the instructions contained in your User's Manual.
3. The blood glucose test result will be shown on the meter display window. This result should fall within the target range. Your healthcare professional should recommend your target range. If your blood glucose test results are higher or lower, ask your healthcare professional what to do. Always consult your healthcare professional before making any changes to your treatment plan.
IMPORTANT: On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System and On Call GU Dual Blood Glucose & Uric Acid Monitoring System allow alternative sites testing for forearm and palm testing in additional to fingertip testing. There are important differences between forearm, palm and fingertip samples that you should know.
Important information about forearm and palm glucose testing: When blood levels are changing rapidly such as after a meal, insulin dose or exercise, blood from the fingertips may show these changes more rapidly than blood from other areas.
Fingertips should be used if testing is within 2 hours of a meal, insulin dose or exercise and any time you feel glucose levels are changing rapidly.
You should test with the fingertips anytime there is a concern for hypoglycemia or you suffer from hypoglycemia unawareness.
Range of Expected Values: Blood glucose monitoring requires the help of a healthcare professional. Together you can set your own range of expected blood glucose values, arrange your testing times, and discuss the meaning of your blood glucose results.
Expected blood glucose levels for people without diabetes: See Table 8.
OnCallSureSyncT8_TH_v1
Checking the System: Your blood glucose meter must be handled carefully. See your User's Manual for detailed instructions for meter care. The quality control test should be used to check that the meter and test strips are working together properly. Follow the test procedure in your User's Manual to run a quality control test. Three ranges CTRL 0, CTRL 1 and CTRL 2 are shown on the test strip vial label. Control Solution 1 is sufficient for most all self-testing needs. If you think your meter or strips may not be working correctly, you may also want to do a Control Solution 0 or Control Solution 2 test. Contact your dealer for information on purchasing control solution.
For confirmation of results, Control Solution 0 tests should fall within the CTRL 0 range, Control Solution 1 tests should fall within the CTRL 1 range and Control Solution 2 tests should fall within the CTRL 2 range. When testing with Control Solution 1, make sure you are matching the results to the CTRL 1 range on the vial label.
CAUTION: If your quality control test result falls outside the control range shown on the test strip vial, DO NOT use the system to test your blood, as the system may not be working properly. If you cannot correct the problem, contact your distributor for help.
Glucose Control Solution: 1. Insert a new test strip to turn on the meter. Refer to your meter's User's Manual details on how to record the result as a quality control test and for further details on operating the meter.
2. Shake the control solution bottle thoroughly.
3. Squeeze the control solution bottle gently and discard the first drop. If the tip clogs, tap the tip gently on a clean, hard surface, shake again, and then use.
4. Squeeze out a second small drop on a clean nonabsorbent surface. Touch the sample tip of the test strip to the control solution drop and ensure the strip get sufficient sample.
Notes: Do not apply control solution to the test strip directly from the bottle.
If you applied the control solution sample but do not see the starting of the count down, you may reapply a second drop within 3 seconds.
5. Read the result from the meter display.
Expected Results: Control solution test results should be within the control range. The ranges for CTRL 0, CTRL 1 and CTRL 2 are displayed on the test strip vial (or on the foil pouch). For confirmation of results, Control Solution 0 tests should fall within the CTRL 0 range, Control Solution 1 tests should fall within the CTRL 1 range, and Control Solution 2 tests should fall within the CTRL 2 range. If the test results with control solution fall within the specified control range, it indicates your Blood Glucose Monitoring System is working properly and you are performing the procedure correctly.
If the control solution test results do not fall within the respective ranges: Check the expiration date of the test strip and control solution. Discard any expired test strips or control solution.
Confirm the temperature in which you are testing is between 10 and 40°C (50-104°F).
Make sure that the test strip vial and the control solution bottle have been tightly capped.
Confirm that you are using On Call Sure brand control solution.
Make sure that you followed the test procedure correctly.
After checking all of the conditions listed previously, repeat the control solution test with a new test strip. If your results still fall outside the range indicated on the test strip vial label or on the foil pouch, your meter may not be working properly. DO NOT use the system to test blood. Contact your dealer for help. For complete instructions, refer to the User's Manual included with your meter. For additional questions or issues with this product, contact your dealer for help.

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MEDICAL DEVICE - Healthcare Device