GAL-1C BLOOD GLUCOSE MONITORING SYSTEM, GAL-1C TEST STRIPS

{0} 1 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k102816 B. Purpose for Submission: New device C. Measurand: Whole blood glucose D. Type of Test: Quantitative, amperometric, glucose oxidase E. Applicant: Apex Biotechnology Corporation F. Proprietary and Established Names: GAL-1C Blood Glucose Monitoring System GAL-1C Glucose Test Strips Contrex Plus III Glucose Control Solutions G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345 Glucose Test System 21 CFR 862.1660 Quality Control Material 2. Classification: Class II {1} Class I, reserved 3. Product code: NBW - Blood glucose test system, over the counter CGA - Glucose oxidase, glucose test system JJX - Single (specified) analyte controls 4. Panel: 75-Clinical Chemistry H. Intended Use: 1. Intended use(s): Refer to indications for use below. 2. Indication(s) for use: The GAL-1C Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (in vitro diagnostic use). It is indicated for lay use by people with diabetes, as an aid to monitoring levels in Diabetes Mellitus and should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use. The GAL-1C Blood Glucose Test Strips are to be used with the GAL-1C Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). They are not indicated for the diagnosis or screening of diabetes or for neonatal use. The purpose of the Contrex Plus III Glucose Control Solutions is to validate the performance of the blood glucose monitoring system using a testing solution with a known range of glucose. A control test that falls within the acceptable range indicates the user's technique is appropriate and the test strip and meter are functioning properly. 3. Special conditions for use statement(s): - Alternative site testing (palm and forearm) can be used only during steady-state blood glucose conditions. {2} - AST should not be used to calibrate CGMs or used in insulin dosing calculations - Not for use on critically ill patients, patients in shock, dehydrated patients, hypotensive patients or hyperosmolar patients. 4. Special instrument requirements: Apex Biotechnology Corporation, GAL-1C Blood Glucose Meter I. Device Description: The GAL-1C blood glucose meter and GAL-1C test strips are used for testing of blood glucose by self-testers at home with Contrex Plus III Glucose Control Solutions for quality control testing. The GAL-1C Blood Glucose Monitoring System consists of a blood glucose meter, blood glucose test strips, lancing device, user guide, and logbook. Three levels of glucose control solutions are sold separately and can be obtained using the contact phone number provided in the user guide. The GAL-1C allows the palm and forearm to be used as an alternative testing site. J. Substantial Equivalence Information: 1. Predicate device name(s): GlucoSure STAR Blood Glucose Monitoring System Contrex Plus Glucose Control Solution 2. Predicate 510(k) number(s): k073648 k100747 3. Comparison with predicate: | Comparison Table: Blood Glucose Monitoring System | | | | --- | --- | --- | | Item | Device (k102816) | Predicate (k073648) | | Indications for Use | For the quantitative measurement of glucose in fresh capillary whole blood. | same | | Intended Users | Lay users | Lay users and healthcare professionals | | Testing Site | fingertips AST: palm, forearm, | same | | Detection method | Amperometry | same | | Enzyme | Glucose Oxidase (Aspergillus niger) | same | | Plasma-calibrated | Yes | same | | Measurement range | 20-600 mg/dL | same | {3} | Comparison Table: Blood Glucose Monitoring System | | | | --- | --- | --- | | Item | Device (k102816) | Predicate (k073648) | | Sample volume | 0.8 uL | 1.0 uL | | Reaction time | 6 seconds | same | | Meter dimensions | 56(L) x 63(W) x 13(H) | 90(L) x 53(W) x 20(H) | | Meter weight | 39g | 80g | | Hematocrit | 30-55% | 30-55% | | Operating conditions | 10-40°C, <85% R.H. | same | | Coding | Autocoding | Manual coding required | | Memory feature | 300 measurements | same | | Day average | 7-, 14-, 30-days | same | | Auto Shut Off | 1.5 minutes | 2 minutes | | Battery Type | 2 Alkaline AAA | 1 CR2032 3V Lithium | | Test Strips Stability | Unopened Store at 4-30°C until expiration date Opened 4-30°C for 3 months | same | | Comparison Table: Control Solutions | | | | --- | --- | --- | | Item | Device (k102816) | Predicate (k100747) | | Intended Use | Validate the performance of the Blood Glucose Monitoring System using a testing solution with a known range of glucose | same | | Number of Levels | 3 | 2 | | Color Dye | Red | none | | Fill Volume | 3.0 mL | 3.6 mL | | Matrix | Aqueous solution containing D-glucose | same | | Control Stability | Store at 15-30°C until expiration date | Store at room temperature until expiration date | # K. Standard/Guidance Document Referenced (if applicable): 1. ISO 15197. In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. 2. CLSI EP6-A. Evaluation of the Linearity of Quantitative Measurement Procedures; Approved Guideline. 3. IEC 60601-1-2:2001. Medical electrical equipment, Part 1-2. General requirements for basic safety and essential performance. Electromagnetic Compatibility. 4. IEC 61000-3-2:2005. Electromagnetic Compatibility, Part 3-2. Limits-Limits for harmonic current emissions. {4} 5. EN 61000-3-3:2008. Electromagnetic Compatibility, Part 3-3. Limits-Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems, for equipment with rated current $\leq 16\mathrm{A}$ per phase and not subject to conditional connection. 6. IEC 61326-1:2006. Electrical equipment for measurement, control, and laboratory use. EMC Requirements. General requirements. 7. IEC 61326-2-6:2005. Electrical equipment for measurement, control, and laboratory use. EMC Requirements. General requirements, Part 2-6. Particular requirements-In Vitro diagnostic medical equipment. 8. EN 61010-1:2010. Safety requirements for electrical equipment for measurement, control, and laboratory use, Part 1. General requirements. 9. IEC 61010-2-101:2002. Safety requirements for electrical equipment for measurement, control, and laboratory use, Part 2-101. Particular requirements for in vitro diagnostic (IVD) medical equipment. 10. IEC 60601-1. Medical electrical equipment, Part 1. General requirements for safety. 11. EN 55011:2007. Industrial, scientific and medical (ISM) radio-frequency equipment. Electromagnetic disturbance characteristics. Limits and method of measurement. # L. Test Principle: The meter and test strips use amperometric biosensor technology. The test strips contain glucose oxidase which reacts to glucose present in blood, releasing electrons. The meter applies a small electrical current to the test strip and measures changes in the current caused by the reaction of glucose in the blood sample to the enzyme in the test strip. The meter converts the measured current into a blood glucose reading that is displayed on the meter's liquid crystal display. Test strips are plasma calibrated. # M. Performance Characteristics (if/when applicable): # 1. Analytical performance: # a. Precision/Reproducibility: Within-run, between run, and overall precision for the device were determined for a duration of 20 days using venous whole blood samples (HCT $43 \pm 2\%$ ) spiked with glucose or allowed to undergo glycolysis to achieve a glucose range of 50 to 440 mg/dL. Testing was completed using ten GAL-1C meters and three different test strips lots. In addition, precision studies included two levels of control solution. The mean, standard deviation (SD), and coefficients of variation (CV) were determined for each sample as summarized below: | Precision Data Summary: Venous Blood Samples | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | Strip Lot | Mean (mg/dL) | Within-Run | | Between Run | | Overall | | | | | SD | CV (%) | SD | CV (%) | SD | CV (%) | | 1 | 50 | 2.9 | 5.8 | 0.9 | 1.8 | 3.0 | 6.0 | | 2 | 50 | 2.9 | 5.8 | 0.9 | 1.8 | 3.0 | 6.0 | | 3 | 50 | 2.9 | 5.8 | 0.9 | 1.8 | 3.0 | 6.0 | {5} | Precision Data Summary: Control Solutions | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | Strip Lot | Mean (mg/dL) | Within-Run | | Between Run | | Overall | | | | | SD | CV (%) | SD | CV (%) | SD | CV (%) | | 1 | 110 | 2.4 | 2.2 | 1.6 | 2.2 | 2.9 | 2.2 | | | 212 | 6.1 | 2.9 | 1.6 | 0.7 | 5.2 | 2.5 | | 2 | 111 | 3.6 | 3.2 | 1.5 | 2.2 | 3.6 | 2.2 | | | 211 | 5.3 | 2.6 | 2.2 | 1.0 | 5.5 | 2.6 | | 3 | 110 | 3.8 | 3.4 | 1.1 | 2.2 | 3.3 | 2.2 | | | 208 | 9.3 | 4.4 | 1.7 | 0.8 | 5.2 | 2.5 | # b. Linearity/assay reportable range: Linearity for the device was evaluated using venous blood samples at eight different glucose concentrations ranging from 16 to $602\mathrm{mg / dL}$ (HCT $43\pm 2\%$ ). Forty measurements for each glucose level $(N = 320)$ were conducted on one meter and three strip lots. Regression analysis showed a linear relationship between the GAL-1C glucose monitoring system and glucose concentrations determined with the YSI-2300 reference method. Linear regression analysis data for each test strip lot is shown below: | Strip Lot | Slope (95% CI) | Y-intercept (95% CI) | R2value | | --- | --- | --- | --- | | 1 | 1.014 (1.010 to 1.019) | -2.372 (-3.714 to -1.031) | 0.9984 | | 2 | 1.016 (1.010 to 1.022) | -2.115 (-3.787 to -0.445) | 0.9975 | | 3 | 1.016 (1.012 to 1.020) | -2.046 (-3.210 to -0.883) | 0.9988 | The reportable range of the GAL-1C glucose monitoring system was confirmed to be 20 to $600\mathrm{mg / dL}$ . If a sample is less than $20\mathrm{mg / dL}$ , the result is flagged by the meter as LO. If a sample result exceeds $600\mathrm{mg / dL}$ , the result is flagged by the meter as HI. {6} c. Traceability, Stability, Expected values (controls, calibrators, or methods): Qualification of glucose controls was performed by repeat analyses using three lots of control solutions at each level on the YSI-2300 reference method after calibration using NERL standards traceable to NIST. Pre-determined acceptance criteria for glucose recovery must be met for each control lot. Expected values and acceptable ranges for the controls are determined using ten GAL-1C glucose meters and one lot of GAL-1C test strips, eight strips per meter. Glucose control value ranges are lot dependent and are listed in the test strip vial label for each lot and level. Stability testing protocols and acceptance criteria for the glucose control solutions were reviewed and found to be acceptable. The manufacturer claims a shelf life stability of 18 months and an open-vial stability of 3 months at the recommended storage temperatures of 15°C to 30°C. d. Detection limit: The measuring range of the GAL-1C glucose monitoring system is 20 to 600 mg/dL. This range was verified by the linearity study (see section M.1.b of this decision summary). e. Analytical specificity: Interferences Study: To evaluate interference in glucose measurements by the device, a number of endogenous/exogenous substances at two or more levels (normal/therapeutic and high) were added to whole blood samples (HCT 43±2%) containing three different glucose levels (70-90, 110-130, and 300-330 mg/dL). Glucose measurements obtained from samples containing each potential interfering substance were evaluated and compared against measurements with a control group using the GAL-1C glucose monitoring system. Test and control samples were tested using ten GAL-1C test strips on ten GAL-1C glucose meters. The table below shows the levels with no interference (&lt; 10%) when testing for glucose with the GAL-1C glucose monitoring system: | Substance | No Interference at Listed Level | | --- | --- | | Endogenous Substance | | | Hemoglobin | 200 mg/dL | | Creatinine | 5.0 mg/dL | | Uric Acid | 15 mg/dL | | Cholesterol | 400 mg/dL | {7} | Bilirubin-unconjugated | 15 mg/dL | | --- | --- | | Bilirubin-conjugated | 25 mg/dL | | Triglycerides | 2000 mg/dL | | Exogenous Substance | | | Acetaminophen | 20 mg/dL | | L-Dopa | 1.5 mg/dL | | Tolbutamide | 64 mg/dL | | Dopamine | 0.1 mg/dL | | Ibuprofen | 40 mg/dL | | Salicylic Acid | 65 mg/dL | | Methyl-Dopa | 1.5 mg/dL | | Tetracycline | 1.5 mg/dL | | Ephedrine | 0.05 mg/dL | | Mannitol | 30 mg/dL | | Mannose | 4.0 mg/dL | | Sorbitol | 0.2 mg/dL | | Tolazamide | 60 mg/dL | | Ascorbic Acid | 5.0 mg/dL | | Maltose | 50 mg/dL | | Lactose | 25 mg/dL | | Matotriose | 240 mg/dL | | Maltotetraose | 120 mg/dL | | Xylitol | 0.1 mg/dL | | Xylose | 25 mg/dL | | Fructose | 15 mg/dL | | Galactose | 15 mg/dL | The sponsor included the following limitation statements in the label: - Triglyceride levels up to 2000 mg/dL have no significant effect on test results. Levels above 2000 mg/dL may give falsely low test results (normal range: 30-300 mg/dL). - L-dopa levels above 1.5 mg/dL may cause falsely high test results. People taking this drug should consult their medical professional if they are taking high doses of L-dopa. - Ibuprofen levels above 40 mg/dL may give falsely high test results (therapeutic range: 1-7 mg/dL). - Tolazamide levels above 60 mg/dL may give falsely low test results (therapeutic level: 23 mg/dL). - Ascorbic Acid levels above 5 mg/dL may give falsely high test results (therapeutic range: 0.4-2 mg/dL). - Fructose levels above 15 mg/dL may give falsely high test results (endogenous range: 1-6 mg/dL). - Uric Acid levels above 15 mg/dL may give falsely high test results (normal range: 2.5-8 mg/dL). {8} - Cholesterol levels above 400 mg/dL may give falsely high test results (reference range: 114-201 mg/dL). - Unconjugated bilirubin levels above 15 mg/dL and conjugated bilirubin levels above 25 mg/dL may give falsely high test results (normal ranges: unconjugated bilirubin: 0.3-1.2 mg/dL; conjugated bilirubin: 0-0.3 mg/dL). - Icodextrin and its metabolites (maltose, maltotriose, and maltotetraose) do not significantly affect test results. - Methyldopa will not affect test results in expected blood concentrations. f. Assay cut-off: Not applicable 2. Comparison studies: a. Method comparison with predicate device: Comparison studies were performed using the YSI 2300 analyzer as the reference method according to the ISO 15197 standard. System Accuracy: To demonstrate system accuracy, glucose measurements with 152 fresh capillary blood samples were made by health care professionals. A total of 7 samples were adjusted to achieve low glucose concentrations below 50 mg/dL to cover the glucose range of 34-519 mg/dL. Measurements obtained with the GAL-1C glucose monitoring system were compared to those obtained with the YSI 2300 reference method. The study was performed using eight GAL-1C glucose meter and three lots of GAL-1C test strips. The accuracy data is summarized in tables below. | Accuracy Study Regression Statistics | | | --- | --- | | Number of samples (N) | 152 | | Range (mg/dL) | 34-519 mg/dL | | Slope | 0.992 | | Intercept | -0.65 | | R square | 0.985 | | Accuracy Study Results | | | | | | --- | --- | --- | --- | --- | | Glucose < 75 mg/dL | | | | | | Within ± 5 mg/dL | | Within ±10 mg/dL | | Within ± 15 mg/dL | | 19/28 (68%) | | 25/28 (89%) | | 28/28 (100%) | | Glucose ≥ 75 mg/dL | | | | | | Within ± 5% | Within ±10% | | Within ± 15% | Within ± 20% | | 69/124 (56%) | 112/124 (90%) | | 123/124 (99%) | 124/124 (100%) | {9} b. Matrix comparison: Not applicable 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): User Performance Evaluation: In the user performance study, blood glucose measurements of 145 subjects were evaluated using samples from the fingertips as well as from the claimed alternative testing sites: palm and forearm. Subjects tested their own capillary whole blood samples from the finger, palm, or forearm using the GAL-1C glucose monitoring system following the instructions for use that were provided. Healthcare professionals then tested these samples using the YSI 2300 reference method. The accuracy data is summarized in tables below. | User Performance Study Regression Statistics | | | | | --- | --- | --- | --- | | | User vs. YSI | | | | Testing Site | Fingertip | Palm | Forearm | | Number of samples (N) | 145 | 145 | 145 | | Range (mg/dL) | 60-519 mg/dL | 60-519 mg/dL | 60-519 mg/dL | | Slope | 0.983 | 1.001 | 0.999 | | Intercept | -0.525 | -2.942 | -2.7507 | | R square | 0.983 | 0.982 | 0.982 | | User Performance Study Results | | | | | | | --- | --- | --- | --- | --- | --- | | Glucose < 75 mg/dL | | | | | | | User vs. YSI | Within ± 5 mg/dL | | Within ±10 mg/dL | | Within ± 15 mg/dL | | Fingertip | 10/21 (48%) | | 18/21 (86%) | | 21/21 (100%) | | Palm | 9/21 (43%) | | 19/21 (91%) | | 21/21 (100%) | | Forearm | 12/21 (57%) | | 19/21 (91%) | | 21/21 (100%) | | | | | | | | | Glucose ≥ 75 mg/dL | | | | | | | | Within ± 5 % | Within ±10 % | | Within ± 15 % | Within ± 20% | | Fingertip | 10/21 (48%) | 18/21 (86%) | | 21/21 (100%) | | | Palm | 9/21 (43%) | 19/21 (91%) | | 21/21 (100%) | | | Forearm | 12/21 (57%) | 19/21 (91%) | | 21/21 (100%) | | {10} | Fingertip | 62/124 (50%) | 106/124 (86%) | 122/124 (98%) | 124/124 (100%) | | --- | --- | --- | --- | --- | | Palm | 58/124(47%) | 103/124 (83%) | 120/124 (97%) | 124/124 (100%) | | Forearm | 56/124 (45%) | 102/124 (82%) | 119/124 (96%) | 123/124 (99%) | 4. Clinical cut-off: Not applicable 5. Expected values/Reference range: Expected blood glucose values for nondiabetic adults are as follows: Before meals 70-100 mg/dL After meals 70-140 mg/dL Reference: American Diabetes Association Position Statement: Standards of Medical Care in Diabetes-2010. Diabetes Care 2010; 33 (Suppl. 1): S11-S61. N. Instrument Name: Apex Biotechnology Corporation, GAL-1C Blood Glucose Monitoring System. 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 contain the ability to 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 ☑ 2. Software: FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes ☑ or No ☐ 3. Specimen Identification: {11} 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 fingertip, palm, and forearm which can be applied directly to the test strip. 5. Calibration: This system has an autocoding system; coding of the meter by the user is not necessary. No further calibration is required. 6. Quality Control: The sponsor has three levels of controls available for use with this meter. These control solutions must be purchased separately using the contact information provided in the user guide. When a test strip is inserted into the meter, each control can be measured by following the instructions for "Control Solution Testing" provided in the user guide for the meter. An acceptable range for each control level is printed on the test strip vial label. The user is instructed to contact Customer Service if the control results fall outside these ranges. P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above: 1. A study was performed to assess the ease of use of the labeling by recruiting 50 lay users (aged approximately 20-70 yrs old) who were provided with the test kit containing labeling for the US market. Participants varied in age and education. The number of male participants was 33 (66%) and females, 17 (34%). These lay users also completed a questionnaire to response to whether the device is easy to use and the Instructions for use were written in a way that makes it easy to use. Responses to all questions had average ratings above the "easy" score. 2. Flesch-Kincaid readability assessment was conducted and the results showed that the labeling (User Guide, test strip package insert and control solution package insert) were written at the 8th grade level. 3. Customer service is available between 8:00 am and 5:00 pm-Central Standard Time Monday through Friday. Users are instructed to contact their healthcare providers if out of Central Time. The toll free US phone number is 1-877-979-5454 for customer support. 4. Hematocrit Study: The blood hematocrit (HCT) effect on the performance of the GAL-1C glucose monitoring system was evaluated using five different glucose concentrations ranging from 40-550 mg/dL. Venous blood samples were tested on ten test strips of each 12 {12} of three different lots. Glucose concentrations at each HCT level (30%, 33%, 35%, 43%, 50%, and 55%) were compared to results obtained with the 43% HCT sample tested with the GAL-1C system and with the YSI reference method. Review of the manufacturer's data confirms acceptable performance of the GAL-1C blood glucose monitoring system at HCT 30-55%. 5. **Altitude Study**: The effect of altitude was evaluated by testing venous blood samples at five different glucose concentrations ranging from 50 to 440 mg/dL on the GAL-1C glucose monitoring system. Ten GAL-1C glucose meters and one lot of GAL-1C tests strips were tested along with to levels of control solutions at sea level and at 10,335 feet above sea level. The YSI 2300 was used as the reference method. Data demonstrates acceptable performance of the device up to the claimed altitude of 10,000 feet. 6. **Temperature and Humidity Studies**: The effect of temperature and humidity on the performance of the GAL-1C glucose monitoring system was evaluated using venous whole blood samples at four different levels (50, 120, 200, and 400 mg/dL). Twenty replicates were tested at each glucose level with ten GAL-1C glucose meters using three lots of strips. Glucose concentrations at the following temperature and humidity conditions were evaluated and compared with results obtained with the YSI-2300 reference method. Temperature: 10, 14, 20, 24, 30, 40 ± 2°C at 45-55% RH. Relative Humidity: 20% ± 5% at 10°C and 40°C 50% ± 5% at 24°C 85% ± 5% at 10°C and 40°C 90% ± 5% at 10°C and 40°C The study results met pre-determined acceptance criteria and support the temperature and humidity claims of 10-40°C and 20-85% RH. 7. A sample volume study was performed to verify the test strip sample volume requirement and the test strip fill error requirement established for the GAL-1C blood glucose monitoring system. Three lots of test strips were tested using venous blood samples, each adjusted to a glucose concentration of 50-70, 100-140, and 310-350 mg/dL. Blood at each concentration was applied to strips at nine target sample volumes of 0.2, 0.3, 0.6, 0.7, 0.8, 0.8, 1.0, 1.1, and 1.5 μL. Protocols and acceptance criteria were provided and found to be acceptable. The sponsor concluded that sample volume of ≥0.8 μL produced accurate results and samples &lt;0.8 μL give an error code. 8. The device is intended for single-patient use only. Dispatch towels with EPA registration # 56392-8 were validated demonstrating complete inactivation of live virus for use with the meter and lancing device. The sponsor also demonstrated that there was no change in performance or in the external materials of the meter and lancing device after 1825 cleaning and disinfection cycles designed to simulate 5 years of device use. 9. EMC testing was evaluated and certified by QuieTek Corporation and a test report was issued to Apex Biotechnology Corp. on September 23, 2010. 13 {13} 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. 14