RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM550

{0} 1 # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k092052 B. Purpose for Submission: Clearance of a new device C. Measurand: Whole blood glucose D. Type of Test: Quantitative amperometric assay (Glucose Oxidase) E. Applicant: Bionime Corporation F. Proprietary and Established Names: Rightest Blood Glucose Monitoring System, Model GM550 G. Regulatory Information: 1. Regulation section: 21 CFR § 862.1345 Glucose Test System 21 CFR 862.1660, Quality Control Material (assayed and unassayed) 2. Classification: Class II (assay) and Class I, reserved (controls) 3. Product code: NBW, Blood Glucose Test System, Over-the-Counter CGA, Glucose Oxidase JJX, Single (specified) analyte controls (assayed and unassayed) 4. Panel: 75 (Clinical Chemistry) H. Intended Use: 1. Intended use(s): See indication(s) for use below 2. Indication(s) for use: {1} The Rightest Blood Glucose Monitoring System, Model GM550 is intended for the quantitative measurement of glucose in capillary whole blood from the fingertip, palm and forearm by professional healthcare personnel in clinical settings or diabetics at home to measure the glucose concentration for aiding diabetes management. This device is not intended for testing neonate blood samples and is not intended for the diagnosis of or screening for diabetes mellitus. Rightest Blood Glucose Test Strips GS550 are intended for use with the Rightest GM550 Blood Glucose meter in the quantitative measurement of glucose in capillary whole blood from the fingertip, palm and forearm. Rightest Control Solutions are intended for use with the Rightest Blood Glucose Monitoring System, Model GM550 to check that both the glucose meters and test strips are working properly. These solutions contain a known range of glucose, as indicated on the bottles. 3. Special conditions for use statement(s): - Provides plasma equivalent results - For In Vitro diagnostic use only - Not for use with neonates - Not intended for the screening or diagnosis of diabetes mellitus - Not for use on critically ill patients, patients in shock, dehydrated patients or hyperosmolar patients 4. Special instrument requirements: Rightest Blood Glucose Meter, Model GM550 I. Device Description: The Rightest Blood Glucose Monitoring System, Model GM550 is comprised of the Rightest Blood Glucose Meter, Model GM550, Rightest Blood Glucose Test Strips GS550, Rightest Control Solutions (2 levels) and a lancing device with lancets. J. Substantial Equivalence Information: 1. Predicate device name(s): Bionime Rightest Blood Glucose Monitoring System 2. Predicate 510(k) number(s): k062567 3. Comparison with predicate: The proposed device and its intended use and indications for use are the same as the predicate as cleared in k062567. The table below lists the differences between this device and the predicate. {2} | Differences | | | | --- | --- | --- | | Item | Device | Predicate | | Sample Volume | 1.0 ul | 1.4 ul | | Test Time | 5 seconds | 8 seconds | | Interference | Uric acid > 10 mg/dL | Uric acid > 9 mg/dL | | Hematocrit | 30 - 60% | 30 – 55% | | Strip Reagent | 1. Glucose Oxidase 14.8% 2. Potassium ferricyanide 39.5% 3. Non-reactive ingredients 45.7% | 1. Glucose Oxidase 8.5% 2. Potassium ferricyanide 48.5% 3. Non-reactive ingredients 43% | | Control Solution (Normal level) | 1. Water 84% 2. d-Glucose 0.3% 3. Viscosity enhancing agent 29.5% 4. Inorganic salts/Buffers 1% 5. Dye 0.08% 6. Preservative 0.03% | 1. Water 83% 2. d-Glucose 0.1% 3. Viscosity enhancing agent 15% 4. Inorganic salts/Buffers 1.4% 5. Dye 0.005% 6. Preservative 0.03% | | Control Solution (High level) | 1. Water 69% 2. d-Glucose 0.3% 3. Viscosity enhancing agent 15% 4. Inorganic salts/Buffers 1% 5. Dye 0.08% 6. Preservative 0.03% | 1. Water 83% 2. d-Glucose 0.3% 3. Viscosity enhancing agent 15% 4. Inorganic salts/Buffers 1.4% 5. Dye 0.005% 6. Preservative 0.03% | | Coding | Auto code | Code key | | Memory Capacity | 500 tests; 1, 7, 14, 30, 90 day averages | 300 tests; 1, 7, 14, 30 day averages | | Power Supply | Two CR20032 batteries | Two 1.5V(AAA) batteries | | Meter Dimension | 90.6 mm x 46 mm x 16.5 mm | 85.0 mm x 58.0 mm x 22.0 mm | | Meter Weight | 53.0 +/- 5 g with batteries | 85.0 g with batteries | {3} 4 K. Standard/Guidance Document Referenced (if applicable): - EN 60601-1-2: (2001): Medical electrical equipment Part 1-2: General requirements for safety Collateral standard: Electromagnetic compatibility Requirements and tests-Edition 2.1; Edition 2:2001 consolidated with amendment 1:2004 - ISO 15197:2003, In Vitro Diagnostic Test Systems—Requirements for Blood Glucose Test Systems for Self Managing Diabetes Mellitus - ISO 14971:2007, Medical devices – Application of risk management to medical devices - CLSI EP5-A, Evaluation of Precision Performance of Clinical Chemistry Devices; Approved Guideline - CLSI EP9-A2, Method Comparison and Bias estimation using patient samples L. Test Principle: The Rightest Blood Glucose Monitoring System, Model GM550 uses electrochemical methodologies. The system quantitatively measures blood glucose levels using an amperometric method, which involves detecting the current produced from glucose oxidation. The electrons generated during this reaction are transferred from the blood to the electrodes. The magnitude of the resultant current is proportional to the concentration of glucose in the specimen and the signal is converted into a readout displayed on the meter. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: The within-run precision was tested using venous blood samples spiked to three different glucose concentrations. Each sample was tested in ten replicates with two test strip lots and five glucose meters, for a total of 50 measurements per meter, per level. Results are summarized in the following tables: Within run: | Level 1 | Meter #1 | Meter #2 | Meter #3 | Meter #4 | Meter #5 | | --- | --- | --- | --- | --- | --- | | N | 50 | 50 | 50 | 50 | 50 | | Mean (mg/dL) | 99.9 | 100.7 | 100.6 | 100 | 100.4 | | SD (mg/dL) | 1.29 | 0.48 | 1.17 | 1.15 | 1.26 | | CV (%) | 1.3 | 0.5 | 1.2 | 1.2 | 1.3 | | Level 2 | Meter #1 | Meter #2 | Meter #3 | Meter #4 | Meter #5 | | --- | --- | --- | --- | --- | --- | | N | 50 | 50 | 50 | 50 | 50 | | Mean (mg/dL) | 209.4 | 208.4 | 207.4 | 207 | 206.7 | | SD (mg/dL) | 4.2 | 1.9 | 3.31 | 2.67 | 2.41 | | CV (%) | 2.0 | 0.9 | 1.6 | 1.3 | 1.2 | {4} Five levels of control materials over the claimed assay range were used to establish the between-day precision. Each sample was analyzed in duplicate on five Rightest Blood Glucose Monitoring System, Model GM550 glucose meters by one operator over 20 consecutive days using two lots of test strips, for a total of 80 measurements per meter per level. Results are summarized in the following tables: Between day: | Control P-01 | YSI | Meter #1 | Meter #2 | Meter #3 | Meter #4 | Meter #5 | | --- | --- | --- | --- | --- | --- | --- | | N | 80 | 80 | 80 | 80 | 80 | 80 | | Mean glucose (mg/dL) | 47.5 | 40.9 | 40.8 | 40.8 | 41.3 | 41.1 | | Std Dev | 1.2 | 1.3 | 1.3 | 1.5 | 1.4 | 1.3 | | % CV | 2.6% | 3.1% | 3.2% | 3.6% | 3.3% | 3.2% | | Control P-02 | YSI | Meter #1 | Meter #2 | Meter #3 | Meter #4 | Meter #5 | | --- | --- | --- | --- | --- | --- | --- | | N | 80 | 80 | 80 | 80 | 80 | 80 | | Mean glucose (mg/dL) | 98.3 | 104.4 | 104.1 | 103.7 | 103.8 | 104.8 | | Std Dev | 1.9 | 3 | 2.8 | 2.5 | 2.4 | 2.6 | | % CV | 1.9% | 2.8% | 2.7% | 2.4% | 2.3% | 2.4% | | Control P-03 | YSI | Meter #1 | Meter #2 | Meter #3 | Meter #4 | Meter #5 | | --- | --- | --- | --- | --- | --- | --- | | N | 80 | 80 | 80 | 80 | 80 | 80 | | Mean glucose (mg/dL) | 137.1 | 137.9 | 137.9 | 140.8 | 141.7 | 141.5 | | Std Dev | 2.5 | 2.6 | 3.4 | 3.3 | 3.0 | 2.9 | | % CV | 1.8% | 1.9% | 2.4% | 2.3% | 2.1% | 2.1% | | Control P-04 | YSI | Meter #1 | Meter #2 | Meter #3 | Meter #4 | Meter #5 | | --- | --- | --- | --- | --- | --- | --- | | N | 80 | 80 | 80 | 80 | 80 | 80 | | Mean glucose (mg/dL) | 207.9 | 210.0 | 208.03 | 210.7 | 209.3 | 210.7 | | Std Dev | 3.7 | 4.0 | 3.7 | 4.0 | 3.8 | 4.3 | | % CV | 1.8% | 1.9% | 1.8% | 1.9% | 1.8% | 2.0% | | Control P-05 | YSI | Meter #1 | Meter #2 | Meter #3 | Meter #4 | Meter #5 | | --- | --- | --- | --- | --- | --- | --- | | N | 80 | 80 | 80 | 80 | 80 | 80 | | Mean glucose (mg/dL) | 382.2 | 381.3 | 381.6 | 382.7 | 380.1 | 380.6 | | SD | 7.59 | 8.13 | 9.65 | 7.45 | 9.61 | 9.31 | | CV | 1.99% | 2.10% | 2.52% | 1.95% | 2.53% | 2.45% | {5} b. Linearity/assay reportable range: To determine the linearity of the candidate device, venous blood samples with fourteen different blood glucose levels, including samples below and above measuring range, with the hematocrit between 35% and 50%, were tested with two lots of test strips (lot #1 and lot #2), on the Rightest Blood Glucose Monitoring System, Model GM550 glucose meter in replicates of four. The YSI 2300 glucose analyzer was used as the reference method. The measuring range of the device is 20 to 600 mg/dL. Linear Regression Analysis: Lot 1: y = 1.0036x - 1.2669, r² = 0.9993 Lot 2: y = 1.0044x - 1.6563, r² = 0.9992 c. Traceability, Stability, Expected values (controls, calibrators, or methods): The method comparison was performed using the proposed device and a laboratory analyzer. The stability of the Rightest GS550 blood glucose test strips was demonstrated by real-time stability studies. The YSI 2300 was used as a reference method. The unopened shelf life, currently in progress, is 12 months and the open-vial stability is 6 months at the recommended storage temperatures of 39°F to 86°F. Value assignment for use of the control solutions with the Rightest GS550 blood glucose test strips is based on measurements using the YSI 2300 reference method after calibration with YSI 2747 calibrator solution (NIST SRM #917b Clinical Dextrose). The values for the Control Solutions are assigned by repeat analysis using three different lots of GS550 test strips and ten Rightest Blood Glucose Monitoring Systems, Model GM550 meters. The mean and standard deviation are used to establish the acceptable range for the strips. The range for each control solution is provided in the labeling. Stability characteristics of the Rightest Control Solutions were determined using real-time studies. The unopened shelf-life is 24 months and the open vial stability is 90 days at the recommended storage of 39°F to 86°F. d. Detection limit: The measuring range of the system is 20 to 600 mg/dL. This range was verified by the linearity study above. For values below 20 mg/dL the meter reads 'LO'. For values above 600 mg/dL the meter reads 'HI'. e. Analytical specificity: A blood sample was collected from a volunteer and separated into aliquots. The glucose levels were adjusted to low, normal and high concentrations by supplementing each sample with a glucose solution. Each potential interfering substance was added to aliquots of the low, normal and high glucose blood samples and {6} compared to the same sample without the potential interfering substance (control). The following substances were evaluated: a) exogenous: acetaminophen, ascorbic acid, dopamine, ibuprofen, L-dopa, methyldopa, salicylic acid, tetracycline, tolbutamide; b) endogenous: bilirubin-conjugated, cholesterol, creatinine HCl, triglycerides, uric acid; c) saccharide: maltose, xylose, galactose, lactose. All these compounds at the maximum concentrations specified below did not significantly interfere with the measurements (bias less than $\pm 10\%$ ). | Endogenous Substance tested | Endogenous substance: Maximum Concentration | Number of Replicates | | --- | --- | --- | | Bilirubin | 25 mg/dL | 5 | | Cholesterol | 500 mg/dL | 5 | | Creatinine | 6.61 mg/dL | 5 | | Triglycerides | 1500 mg/dL | 5 | | Uric acid | 9 mg/dL | 5 | | Exogenous Substance tested | Exogenous substance: Maximum Concentration | Number of Replicates | | --- | --- | --- | | Acetaminophen | 26 mg/dL | 5 | | Ascorbic Acid | 6 mg/dL | 5 | | Dopamine HCl | 3 mg/dL | 5 | | Ibuprofen | 50 mg/dL | 5 | | L-Dopa | 4 mg/dL | 5 | | Methyldopa | 1.5 mg/dL | 5 | | Salicylic Acid | 20 mg/dL | 5 | | Tetracycline | 1.5 mg/dL | 5 | | Tolbutamide | 65 mg/dL | 5 | | Saccharide | Maximum Concentration tested | Number of Replicates | | --- | --- | --- | | Maltose | 50 mg/dL | 5 | | Xylose | 100 mg/dL | 5 | | Galactose | 50 mg/dL | 5 | | Lactose | 50 mg/dL | 5 | However, Uric acid (10 mg/dL, 14 mg/dL and 16 mg/dL) at normal glucose levels significantly interfered (&gt;10% bias) with the measurements. The sponsor included the {7} following warning in the label: "Uric acid at $10 / \mathrm{mg} / \mathrm{dL}$ and above may result in inaccurate blood glucose reading." f. Assay cut-off: Not applicable # 2. Comparison studies: a. Method comparison with predicate device: # Method Comparison: A consumer study was performed with 114 lay-users and a technician to see if glucose readings from the forearm, palm and fingertip were comparable to a laboratory glucose method (Olympus 2700). The lay user population ranged in age, education, and was about equally divided between males and females. The blood samples with glucose concentrations ranging from 40 to $491\mathrm{mg / dL}$ were tested on two Rightest Blood Glucose Monitoring Systems, Model GM550 glucose meters (the proposed device). Five percent of the samples below $50\mathrm{mg / mL}$ were glycolyzed by allowing samples to stay at room temperature and then tested. These measurements were compared to the measurements obtained with the laboratory analyzer method. Distribution of blood glucose concentration across the samples tested was in accordance with the ISO15197. The studies met the ISO 15197 accuracy criteria where ninety-five percent $(95\%)$ of the individual glucose results shall fall within $\pm 15\mathrm{mg / dL}$ of the results at glucose concentrations $&lt; 75\mathrm{mg / dL}$ and within $\pm 20\%$ at glucose concentrations $\geq 75\mathrm{mg / dL}$ . Results are summarized in the following tables: | Patient | Fingerstick vs. Laboratory Analyzer | Palmstick vs. Laboratory Analyzer | Armstick vs Laboratory Analyzer. | | --- | --- | --- | --- | | n = | 114 | 114 | 114 | | Regression | y = 0.96x - 0.29 | y = 0.96x + 0.08 | y = 0.95x + 0.20 | | r value | 0.989 | 0.991 | 0.988 | | System Accuracy | | | | | Samples < 75 mg/dL within ±15 mg/dL | 19/19 (100%) | 19/19 (100%) | 18/19 (94.7%) | | Samples ≥ 75 mg/dL within ± 20% | 92/95 (96.8%) | 92/95 (96.8%) | 93/95 (97.9%) | | Technician | Fingerstick vs. Laboratory Analyzer | Palmstick vs. Laboratory Analyzer | Armstick vs. Laboratory Analyzer | | --- | --- | --- | --- | | n = | 114 | 114 | 114 | | Regression | y = 0.96x - 2.32 | Y = 0.96x - 2.47 | y = 0.96x - 4.36 | | r value | 0.989 | 0.989 | 0.987 | {8} 9 | System Accuracy | | | | | --- | --- | --- | --- | | Samples < 75 mg/dL within ±15 mg/dL | 19/19 (100%) | 18/19 (94.7%) | 18/19 (94.7%) | | Samples ≥ 75 mg/dL within ±20% | 93/95 (97.9%) | 91/95 (95.8%) | 91/95 (95.8%) | b. Matrix comparison: This system is for use with fingerstick, palm, and forearm capillary samples. The meter’s software adjusts the whole-blood glucose reading to a plasma-equivalent reading. 3. Clinical studies: a. Clinical Sensitivity: Not Applicable. b. Clinical specificity: Not Applicable. c. Other clinical supportive data (when a. and b. are not applicable): 4. Clinical cut-off: Not Applicable. 5. Expected values/Reference range: The normal fasting adult glucose range for a non-diabetic is 70 – 99 mg/dL (referenced from Diabetes Information – American Association for Clinical Chemistry (AACC), retrieved June 15, 2010. N. Instrument Name: Rightest Blood Glucose Meter, Model GM550 O. System Descriptions: 1. Modes of Operation: Each test strip is single use and must be replaced with a new strip for additional readings. Does the applicant’s device transmit data to a computer, webserver, or mobile device? Yes ☐ or No ☑ Does the applicant’s device transmit data to a computer, webserver or mobile device using wireless transmission? Yes ☐ or No ☑ {9} 10 2. Software: FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes ☐ x _____ or No _____ 3. Specimen Identification: There is no sample identification function with this device. Samples are applied directly to the test strip as they are collected. 4. Specimen Sampling and Handling: This device is intended to be used with capillary whole blood from the finger, palm, and forearm. Since the whole blood sample is applied directly to the test strip there are no special handling or storage issues. 5. Calibration: A single calibration code is programmed into the meters (software) at the time of manufacturing and no user input is required for calibration. 6. Quality Control: The sponsor has two levels of controls available for this meter and the labeling provides recommendations on when to test, such as before using the meter, when an new vial of strips are opened, if the meter is dropped, damaged or exposed to liquids, when the results are suspected to be inaccurate. An acceptable range for each control level is printed in the control labeling. The user is referred to the troubleshooting section of the User’s Manual if control results fall outside these ranges. Customer service is available from Monday through Friday 8:00 AM to 5:00 PM PST. Toll free phone number is 1-888-481-8485 for customer support. The user is instructed to contact the Customer service line during the operational times or a healthcare provider outside the operational times if the control results fall outside these ranges. P. Other Supportive Instrument Performance Characteristics Data Not Covered In The “Performance Characteristics” Section above: Altitude study: An altitude study was performed to evaluate the altitude effect on venous blood samples. The venous blood samples containing low, medium and high glucose concentration (30-50 mg/mL, 80-120 mg/mL and 240-360 mg/mL) were tested at 0, 1000, 2000 and 3000m. The YSI 2300 was used as a reference. Results of these studies are summarized below: | | Bias | | --- | --- | | Venous blood - low glucose (30-50 mg/mL) | - 5.5% - 6.2% | | Venous blood - medium glucose (80-120 mg/mL) | -3.1% - 3.2% | | Venous blood - high glucose (240-360 mg/mL) | -5.7% - 4.4% | {10} The sponsor included the following warning in the label: “Incorrect test results may be obtained at high altitude more than about 3048 meters (10000 feet) above sea level.” **Hematocrit study**: To study the effect of hematocrit, venous blood samples at three glucose concentrations (40-70 mg/dL, 110-200 mg/dL and 300-450 mg/dL) and hematocrit adjusted to 20, 25, 30, 40, 50, 55, 60, and 70 were evaluated on the Rightest Blood Glucose Monitoring System, Model GM550 and compared to the YSI values obtained on the YSI 2300D STAT glucose analyzer. The sponsor included the following warning in the label: “Hematocrits below 30% may cause higher results, and hematocrits above 60% may cause lower results.” **Temperature and humidity study**: Studies were performed to demonstrate that this device can be used at temperatures from 10 to 40 °C and at relative humidity ranging from 10 to 90 %. Glucose control solutions with two glucose concentrations (approximately 100 and 300 mg/dL) were used for the studies. The YSI 2300 was used as a reference method. The results were reviewed and found to be acceptable (bias less than ±10%). **A usability study** was performed to assess the readability of the labeling. Flesch-Kincaid readability assessment was conducted and the sponsor concluded that the 8th grader would be able to read the entire labeling material. **Lay user questionnaire**: 114 lay users evaluated the ease of use of the device and the presentation of the labeling. All users thought that the device was easy to use and most answer good and very good that the user manual was written to make it easy to use. **A time function** study was performed to confirm that the performance of the Rightest Blood Glucose Monitoring System, Model GM550 occurs within 5 seconds. **A specimen volume study** was performed to demonstrate that the 1μl volume provides accurate reading. **Electromagnetic Compatibility (EMC)** testing was performed/passed and a certificate to Bionime was provided. **Q. Proposed Labeling**: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. **R. Conclusion**: The submitted information in this premarket notification is complete and supports a substantial equivalence decision.