On Call Sure Sync Mechanism of Action

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.