DTG-GL5PLUS Insert - Clarity Diagnostics
Contents
1. Blood Glucose Test Strips Package Insert JW PRINCIPLE AND INTENDED USE The Clarity Plus Blood Glucose Test Strips are thin strips with a chemical reagent system They work with the Clarity Plus Blood Glucose 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 The reaction takes place in the reaction cell 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 Clarity Plus meters are calibrated to display plasma equivalent results For in vitro diagnostic use Test strips are only to be used outside the body for testing purposes For the quantitative measurement of glucose in capillary whole blood from the finger forearm and palm by people with diabetes at home and by healthcare professionals as an aid in monitoring the effectiveness of diabetes control programs COMPOSITION Each Clarity Plus test strip contains the following reactive chemicals Glucose oxidase from Aspergillus niger lt 25 IU Mediator lt 300 ug Buffer lt 500 ug Non reactive Ingredient lt 1 mg Each test strip vial contains a drying agent STORAGE AND HANDLING e Test strips should be stored in their protective vial The vial s cap must be tightly closed This is2. testing purposes e 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 Only apply the sample to the tip of the test strip Do not apply blood or control solution to the top of the test strip This may result in an inaccurate reading e Check the code chip before running a blood glucose test Make sure to use the code chip that is contained with that vial of strips Insert the code chip into the code chip slot The code chip slot is located on the right side of the meter e Discard the vial and any unused test strips 3 months after you first open it Constant exposure to air may destroy chemicals in the test strip This damage can cause incorrect readings e Keep the test strip vial away from children and animals e Consult your healthcare professional before making any changes in your treatment plan MATERIALS PROVIDED e Test Strips e Code Chip e Package Insert MATERIALS REQUIRED BUT NOT PROVIDED e Meter e Sterile Lancets e Lancing Device e Control Solution INSTRUCTIONS FOR USE See your User s Manual for complete instructions for blood sample collection before use 1 Open the cap of the test strip vial Remove a test strip for testing Replace the cap immediately This is to protect the remaining test strips from moisture in the air 2 Run the blood gluco
3. he Clarity Plus Blood Glucose Monitoring System This study showed that the patient can run the test as accurately as the trained technician Clarity Plus tests Linear regression of Participant y versus YSI Reference value and Linear regression of Technician y versus YSI Reference value StripLot__ TestedBy Slope Intercept R Please refer to your meter s User s Manual for complete instructions For help with any additional questions or issues please contact Clarity Diagnostics Technical Customer Support at 1 877 485 787 REFERENCES 1 ADA Clinical Practice Recommendations 2003 N Clarity Diagnostics LLC Boca Raton Florida 33487 Tech Support 1 877 485 7877 www claritydiagnostics com DIAGNOSTICS Number 1150489602 Printed in China Effective Date 2014 xx xx
4. s Clarity Plus vs YSI Reference x Sample Site Slope Intercept R N Strip Lot 1 Strip Lot 2 Strip Lot 3 0 9972 4 6130 0 9924 0 9702 2 8354 0 9821 0 9419 5 5952 0 9778 Fingertip samples were used for YSI reference measurement The sample range was 43 to 473 mg dL for Clarity Plus Blood Glucose Meter testing with blood sampled from fingertip sites The sample range was 47 to 399 mg dL for Clarity Plus Blood Glucose Meter testing with blood sampled from palm and forearm sites Fingertip Site System Accuracy Results for Glucose Concentration gt 75mg dL Within 5 Within 10 Within 15 Within 20 97 208 46 6 159 208 76 4 194 208 93 3 208 208 100 Fingertip Site System Accuracy Results for Glucose Concentration lt 75mg dL Within 5 mg dL Within 10 mg dL Within 15 mg dL 11 36 30 6 29 36 80 6 36 36 100 Palm Site System Accuracy Results for Glucose Concentration gt 75mg dL Within 5 Within 10 Within 15 Within 20 88 198 44 4 144 198 72 7 187 198 94 4 197 198 99 5 Palm Site System Accuracy Results for Glucose Concentration lt 75mg dL Within 5 mg dL Within 10 mg dL Within 15 mg dL 10 16 62 5 16 16 100 0 16 16 100 0 Forearm Site System Accuracy Results for Glucose Concentration gt 75mg dL 14 16 87 5 16 16 100 0 16 16 100 0 Consumer Study A consumer study was performed by testing three test strip lots Participants and a trained technician used t
5. se test following the User Manual s instructions 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 Clarity Plus Blood Glucose Monitoring System allows alternative site 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 e 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 e 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 e 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 Expec
6. ted blood glucose levels for people without diabetes Range mg dL Range mmol L Fasting and Before Meals 70 100 3 9 5 6 2 Hours After Meal Less than 140 Less than 7 8 CHECKING THE SYSTEM Handle your blood glucose meter 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 Two ranges CTRL Low and CTRL High are shown on the test strip vial label Contact Clarity Diagnostics Customer Technical support at 1 877 485 7877 for information on purchasing the control solution For confirmation of results Low Control tests should fall within the CTRL Low range and High Control tests should fall within the CTRL High range When testing with Low Control make sure you are matching the results to the CTRL Low 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 This may be a sign that the system is not working properly If you cannot correct the problem contact Clarity Diagnostics Technical Support for help LIMITATIONS e The Clarity Plus meter test strips and other components have been designed tested and proven to work together effectively to provide accurate blood glucose measurements Do not use components from o
7. terials Follow proper precautions when disposing of materials PERFORMANCE CHARACTERISTICS Reproducibility Precision Ten replicate assays were each run on ten Clarity Plus 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 MEAN 46 mg dL 79 mg dL 149 mg dL 244 mg dL 380 mg dL Standard Deviation mg dL or 6 o Coefficient of Variation CV 2 5 mg dL 3 3 3 0 3 1 2 4 Intermediate Precision Ten replicate assays drawn from three strip lots were run on ten Clarity Plus 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 intermediate precision estimates Standard Deviation mg dL or Coefficient of Variation CV 3 7 CV 3 3 CV 2 2 mg dL 3 7 CV 3 8 CV 39 mg dL 1 9 mg dL 131 mg dL 4 3 CV System Accuracy The capillary blood glucose measurements from 107 participants were taken by a trained technician using the Clarity Plus Blood Glucose Meter y Capillary blood samples were obtained from fingertip palm and forearm sampling sites for the Clarity Plus Blood Glucose Meter testing Fingertip samples from the same subjects were also analyzed with YSI Model 2300 STAT PLUS Glucose Analyzer x The results were compared Linear Regression Result
8. ther brands e Use only with whole blood Do not use with serum or plasma samples e Do not use for testing newborns e Do not use the meter in any manner not specified by Clarity Diagnostics Otherwise the protection provided by the meter may be impaired e Very high above 55 and very low below 30 hematocrit levels can cause false results Talk to your healthcare professional to find out your hematocrit level e Abnormally high levels of vitamin C Acetaminophen Uric Acid L Dopa Tolazamide or other reducing substances will produce false high blood glucose measurements e The system is tested to accurately read the measurement of glucose in whole blood within the range of 1 1 33 3 mmol L 20 to 600 mg dL e Fatty substances triglycerides up to 3 000 mg dL or cholesterol up to 500 mg dL have no major effect on blood glucose test results e The Clarity Plus Blood Glucose Monitoring System has shown to be properly working at properly in studies at altitudes up to 8 516ft 2 595 meters e Severely ill persons should not run the glucose test with the Clarity Plus Blood Glucose Monitoring System e 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 Clarity Plus Blood Glucose Monitoring System e Dispose of blood samples and materials carefully Treat all blood samples as if they are infectious ma
9. to keep the test strips in good working condition e Store test strips in a cool dry place at room temperature 15 30 C 59 86 F Store them away from heat and direct sunlight Do not freeze or refrigerate Use the test strips at room temperature This is to ensure accurate results Do not store the test strips outside of their protective vial Test strips must be stored in their original vial The cap must be tightly closed 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 bleach or cleaners that contain bleach Do not transfer the test strips to a new vial or any other container Replace the vial cap immediately after removing a test strip Use the test strip immediately after removing it from the vial Do not use your test strips past the unopened expiration date The expiration date is 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 format 2010 01 means January 2010 e A new vial of test strips may be used for 3 months after first being opened The opened vial expiration date is 3 months after the date the vial was first opened Write the opened vial expiration date on the vial label after opening PRECAUTIONS e For in vitro diagnostic use The test strips are to be used only outside the body The test strips are to be used only for
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