ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEM

{0} 1 # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k124021 B. Purpose for Submission: Device Modification (Test strip’s electrode print pattern, capillary gate size, upper logo layers and outer shape have been modified) C. Measurand: Capillary whole blood glucose D. Type of Test: Quantitative amperometric assay (glucose oxidase) E. Applicant: ARKRAY Factory USA, Inc F. Proprietary and Established Names: ARKRAY GLUCOCARD™ 01 Blood Glucose Monitoring System ReliOn Confirm Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345, Glucose Test System 2. Classification: Class II 3. Product code: CGA, NBW 4. Panel: 75(Clinical Chemistry) {1} H. Intended Use: 1. Intended use(s): See indications for use below. 2. Indication(s) for use: GLUCOCARD 01 Blood Glucose Monitoring System: The GLUCOCARD 01 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home by persons with diabetes as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. It is intended for single patient use and should not be shared with other individuals. The GLUCOCARD 01 SENSOR PLUS Blood Glucose Test Strips are intended to be used with the GLUCOCARD 01 Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm. ReliOn Confirm Blood Glucose Monitoring System: The ReliOn Confirm Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home by persons with diabetes as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. It is intended for single patient use and should not be shared with other individuals. The ReliOn Confirm Plus Blood Glucose Test Strips are intended to be used with the ReliOn Confirm Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm. 3. Special conditions for use statement(s): - For over the counter use. - Not for neonatal use - Not for screening or diagnosis of diabetes mellitus - Patients undergoing oxygen therapy may yield false results. - Not for patients who are dehydrated, in shock, critically ill, or in a hyperosmolar state - Palm testing (AST) should not be used to calibrate continuous glucose monitors (CGMs) or for insulin dose calculations. 2 {2} - For single-patient use only. 4. Special instrument requirements: GLUCOCARD™ 01 Blood Glucose Meter ReliOn Confirm Blood Glucose Meter I. Device Description: The GLUCOCARD 01 Blood Glucose Monitoring System is available as either a System Kit consisting of the meter, lancing device, test strips, and control solution (Normal (L2) Control); or as a Meter Kit containing just the meter. The GLUCOCARD 01 SENSOR PLUS blood glucose test strip has been modified from the GLUCOCARD 01 SENSOR blood glucose test strip. The new test strip uses the same chemistry and is identical in length and width to the current test strip. The ReliOn Confirm Blood Glucose Monitoring System consists of the meter and lancing device. Test strips and controls are sold separately. The ReliOn Confirm Plus blood glucose test strip has been modified from the ReliOn Confirm blood glucose test strip. The new test strip uses the same chemistry and is identical in length and width to the current test strip. The GLUCOCARD01 Control and ReliOn Confirm/Micro Controls were previously cleared in k073416 and the three levels have been renamed from L, N, and H to L1, L2 and L3. J. Substantial Equivalence Information: 1. Predicate device name(s): GLUCOCARD 01 Blood Glucose Monitoring System 2. Predicate 510(k) number(s): K073416 3. Comparison with predicate: | Similarities | | | | --- | --- | --- | | Item | GLUCOCARD™ 01 Blood Glucose Monitoring System, ReliOn Confirm Blood Glucose Monitoring System k124021 | Predicate GLUCOCARD 01 Blood Glucose Monitoring System k073416 | | Intended use | The GLUCOCARD 01 and ReliOn Confirm | Same | {3} | Similarities | | | | --- | --- | --- | | Item | GLUCOCARD™ 01 Blood Glucose Monitoring System, ReliOn Confirm Blood Glucose Monitoring System k124021 | Predicate GLUCOCARD 01 Blood Glucose Monitoring System k073416 | | | Blood Glucose Monitoring Systems are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm. They are indicated for use at home by persons with diabetes as an aid to monitor the effectiveness of diabetes control. | | | Strip Chemistry | Glucose oxidase (Aspergillus niger sourced) and hexaammineruthenium (III) chloride | Same | | Calibration | Plasma referenced | Same | | Sample Type | Fresh capillary whole blood drawn from the fingertip or palm | Same | | Calibration | Automatic coded calibration | Same | | Sample Size | 0.3μL | Same | | Test Time | 7 seconds | Same | | Glucose Range (mg/dL) | 20-600 | Same | | Test Strip Open Use Life | 6 months after opening | Same | | Controls Solution(s) | Three levels available | Same | | Control Solution Open Use Life | 90 days after opening | Same | | System Operating Range – Temperature | 50°F to 104°F (10°C to 40°C) | Same | | System Operating Range - Humidity | 20-80% | Same | | Maximum Altitude | 10,000 feet above sea level | Same | {4} | Differences | | | | --- | --- | --- | | Item | GLUCOCARD™ 01 Blood Glucose Monitoring System, ReliOn Confirm Blood Glucose Monitoring System k124021 | Predicate GLUCOCARD 01 Blood Glucose Monitoring System k073416 | | Hematocrit | 30-55% | 30-54% | | Validated cleaning and disinfection instructions | Yes | No | ## K. Standard/Guidance Document Referenced (if applicable): - ISO 15197:2003, In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus - CLSI EP6-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline - CLSI EP7-A2, Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition ## L. Test Principle: The sample (whole blood) is drawn into the tip of the test strip by capillary action. Glucose in the sample reacts with glucose oxidase and hexaamineruthenium (III) chloride in the test strip. This produces hexaamineruthenium (II) chloride. Hexaamineruthenium (II) chloride is produced in proportion to the glucose concentration of the blood sample. Oxidation of the hexaamineruthenium (II) chloride produces an electric current. The meter converts the current to the glucose concentration and displays it as the test result. $$ \beta\text{-D-glucose} + \text{Hexamineruthenium (III) chloride} \xrightarrow{\text{GOD}} $$ $$ \text{D-Glucono-}\delta\text{-Lactone} + \text{Hexamineruthenium (II) chloride} $$ $$ \text{Hexamineruthenium (II) chloride} \rightarrow \text{Hexamineruthenium (III) chloride} + \text{e}^- $$ ## M. Performance Characteristics (if/when applicable): The ReliOn Confirm blood glucose test system is identical to the GLUCOCARD 01 blood glucose test system and was used interchangeably throughout the testing. 1. Analytical performance: a. Precision/Reproducibility: The within-day precision study was performed using venous whole blood collected {5} in sodium heparin sample tubes. The pooled sample was glycolyzed overnight, oxygenated to 60 - 80 mmHg pO2 and adjusted to a hematocrit of 41-44%. The whole blood pool was divided into aliquots and spiked with concentrated glucose solution to achieve five different glucose concentrations, 30-50, 51-110, 111-150, 151-250, and 251-400 mg/dL. Ten replicates of each sample pool were measured with five ReliOn Confirm and five GLUCOCARD 01 meters using three lots of test strips. Reference glucose concentrations were determined with a YSI Model 2300. The results are summarized below: | Glucose Level, mg/dL | Lot | N | YSI (mg/dL) | Meter (mg/dL) | SD (mg/dL) | %CV | | --- | --- | --- | --- | --- | --- | --- | | 30-50 | 1 | 100 | 43.5 | 39.6 | 1.7 | 4.2 | | | 2 | 100 | 48.7 | 43.8 | 2.2 | 5.0 | | | 3 | 100 | 48.7 | 43.6 | 2.2 | 5.1 | | | Mean | | | | 2.0 | 4.8 | | 51-110 | 1 | 100 | 84.3 | 83.5 | 3.2 | 3.8 | | | 2 | 100 | 83.2 | 78.9 | 2.9 | 3.7 | | | 3 | 100 | 83.2 | 79.0 | 3.3 | 4.2 | | | Mean | | | | 3.2 | 3.9 | | 111-150 | 1 | 100 | 131 | 131 | 4.3 | 3.3 | | | 2 | 100 | 132 | 128 | 4.1 | 3.2 | | | 3 | 100 | 132 | 128 | 4.5 | 3.5 | | | Mean | | | | 4.3 | 3.3 | | 151-250 | 1 | 100 | 227 | 222 | 6.6 | 3.0 | | | 2 | 100 | 239 | 229 | 8.7 | 3.8 | | | 3 | 100 | 239 | 228 | 8.5 | 3.7 | | | Mean | | | | 7.9 | 3.5 | | 251-400 | 1 | 100 | 350 | 349 | 7.3 | 2.1 | | | 2 | 100 | 357 | 349 | 9.2 | 2.6 | | | 3 | 100 | 357 | 345 | 9.4 | 2.7 | | | Mean | | | | 8.6 | 2.5 | Between-day precision studies were performed using three levels of control solutions. Each sample was tested on ten days with three different glucose control levels, low, mid, and high. The glucose levels were verified daily with the YSI 2300 analyzer. Each sample was tested on ten meters using three lots of test strips. A different individual conducted the testing each day using five ReliOn Confirm and five GLUCOCARD 01 meters. The results are summarized below: | Glucose Level | Lot | N | Mean (mg/dL) | SD (mg/dL) | %CV | | --- | --- | --- | --- | --- | --- | | 1 | 1 | 100 | 46.6 | 1.7 | 3.6 | | | 2 | 100 | 46.0 | 1.2 | 2.7 | | | 3 | 100 | 46.2 | 1.3 | 2.9 | | | Combined | | 46.3 | 1.4 | 3.1 | | | 1 | 100 | 145 | 4.9 | 3.3 | | | 2 | 100 | 144 | 6.1 | 4.2 | {6} 7 | 2 | 3 | 100 | 145 | 3.2 | 2.4 | | --- | --- | --- | --- | --- | --- | | | Combined | | 145 | 4.9 | 3.4 | | 3 | 1 | 100 | 406 | 13.1 | 3.2 | | | 2 | 100 | 400 | 16.2 | 4.1 | | | 3 | 100 | 403 | 13.3 | 3.3 | | | Combined | | 403 | 14.1 | 3.5 | The pre-defined acceptance criteria for within-day and between-day precision were met. b. Linearity/assay reportable range: Linearity performance of the GLUCOCARD 01 with the new GLUCOCARD 01 SENSOR PLUS test strip was evaluated according to CLSI EP6-A. Venous whole blood was collected in sodium heparin tubes. The blood was pooled and hematocrit was adjusted to 42% ± 1%. Concentrated glucose solution was added to create high (800 mg/dL) and low (10 mg/dL) pools. The high and low pools were mixed in various ratios to produce 15 test samples with glucose concentrations ranging from 10 – 750 mg/dL (13, 23, 43, 75, 95, 123, 204, 263, 333, 406, 500, 520, 567, 685 and 764 mg/dL). The pO2 of each test sample was adjusted to 60-80 mm Hg. The glucose concentration of each test sample was determined with ten GLUCOCARD 01 meters using three lots of the new GLUCOCARD 01 SENSOR PLUS test strips. Reference plasma glucose concentrations of the test samples were determined with a YSI Model 2300 STAT Plus. For this experiment, the 10, 570, 700 and 750 mg/dL samples were determined using test systems configured to allow the reporting of results outside the 'LO' and 'HI' limits in the commercial GLUCOCARD 01 meter software (i.e. below 20 mg/dL and above 600 mg/dL). The results from regression analysis are summarized below: | Test Strip Lot | Linear Regression | 95% CI Slope | 95% CI Intercept | Correlation Coefficient (r) | N | | --- | --- | --- | --- | --- | --- | | 1 | Y = 1.06x - 5.61 | 1.05 - 1.07 | -9.40 to -1.82 | 0.998 | 150 | | 2 | Y = 1.05x - 7.92 | 1.04 - 1.06 | -12.29 to -3.56 | 0.998 | 150 | | 3 | Y = 1.05x - 8.15 | 1.03 - 1.06 | -12.28 to -4.03 | 0.998 | 150 | | Combined | Y = 1.05x - 7.93 | 1.05 - 1.06 | -9.61 to -4.84 | 0.998 | 450 | The results of the linearity study support the claimed measuring range of 20-600 mg/dL. {7} c. Traceability, Stability, Expected values (controls, calibrators, or methods): **Traceability:** The calibration of the GLUCOCARD 01/ReliOn Confirm is traceable to NIST SRM 917c. The method comparison study was performed using the candidate device and YSI Model 2300 analyzer as the reference method (see Section 2.a.). **Test Strip Stability:** The sponsor provided real-time and accelerated studies to verify the closed- and open- vial stability of the test strips. The stability studies were reviewed and found to be acceptable. The closed-vial claim is 18 months when stored at of 18 months at 1-30 °C (34-86 °F) and 20-80% relative humidity. The open-vial stability claim is 3 months when stored at 1-30 °C (34-86 °F) and 20-80% relative humidity. **Control Solution:** The control solutions were previously cleared and stability and value assignment was previously established in k073416. The names of the control solution levels have been changed from L, N and H to L1, L2 and L3. When stored at 34-86 °F (1-30 °C), unopened controls have an 18-month shelf life and are stable for 3 months after opening. d. Detection limit: See the linearity study in section M.1.b. above. e. Analytical specificity: Interference studies were conducted according to a test protocol based on CLSI EP7-A2. Heparinized venous whole blood was divided into two pools and glucose concentrations were adjusted to 100 mg/dL (± 10 mg/dL) and 300 mg/dL (± 30 mg/dL). The glucose concentrations were verified using YSI 2300 STAT Plus. Stock interferent solutions were prepared and spiked in aliquots of the low and high glucose pools to achieve normal (therapeutic) and high (toxic) levels for each substance. "Untreated" control samples were spiked with the carrier solvent only. The glucose concentration of each test sample was determined using five GLUCOCARD 01 meters. Each interferent was tested with three lots of the new GLUCOCARD 01 SENSOR PLUS test strips. The highest concentration for each substance is tabulated below. With the exception of pO2, all other substances tested did not interfere with glucose measurements based upon the sponsor's definition of significant interferences (bias < ± 10% compared to un-spiked samples of glucose ≥ 75 mg/dL, or ≤ ± 10 mg/dL for samples with glucose concentrations < 75 mg/dL). The sponsor has the following limitations in their labeling: "Patients undergoing oxygen therapy may 8 {8} yield false results". | Substance | Level (mg/dL) | | --- | --- | | Acetaminophen | 20 | | Acetylsalicylic acid | 65 | | Ascorbic acid | 6 | | Bilirubin (conjugated) | 30 | | Bilirubin (unconjugated) | 40 | | Cholesterol | 500 | | Creatinine | 5 | | L-DOPA | 13 | | L-Dopamine | 0.09 | | Ephedrine | 0.5 | | Fructose | 100 | | Galactose | 100 | | Gentisic acid | 10 | | Glutathione | 3 | | Hemoglobin | 735 | | Ibuprofen | 50 | | Lactose | 30 | | Maltose | 450 | | Substance | Level (mg/dL) | | --- | --- | | Maltotetraose | 450 | | Maltotriose | 240 | | Mannitol | 800 | | Mannose | 16 | | Methyl-L-DOPA | 1.5 | | Oxygen (pO2) | 100mm Hg | | Pralidoxime | 2056 | | Salicylic acid | 100 | | Tetracycline | 4.0 | | Tolazamide | 10 | | Tolbutamide | 64 | | Triglyceride | 3000 | | Urea | 600 | | Uric acid | 25 | | Warfarin | 10 | | Xylitol | 0.2 | | Xylose | 200 | f. Assay cut-off: Not applicable. 2. Comparison studies: a. Method comparison with predicate device: A system accuracy evaluation was conducted with the GLUCOCARD 01 and ReliOn Confirm Blood Glucose Monitoring Systems using the new GLUCOCARD 01 {9} SENSOR PLUS test strip on 148 adults with Type 1 or Type 2 diabetes. Each participant was given either a GLUCOCARD 01 or ReliOn Confirm blood glucose meter and the corresponding Instruction Manual and Quick Reference Guide. Professional and lay user results of the same participant were collected from the same meter. Professional users obtained glucose results for the participants' capillary blood from fingertip and alternative site testing (AST) and compared the values to those obtained on YSI Model 2300 Analyzers. Two YSI Model 2300 Analyzers were used to determine the reference glucose values for each participant. The study was conducted over 21 test days. Three lots of the new GLUCOCARD 01 SENSOR PLUS test strips were used in the evaluationTest results were obtained from 148 participants. The fingertip data were included in the analyses. An additional 12 samples $(< 50\mathrm{mg / dL}$ or $>400\mathrm{mg / dL})$ were manipulated to meet the glucose distribution across the range $(20 - 595\mathrm{mg / dL})$ . The meter results relative to YSI are as follows: # Fingertip (with supplemental samples): Glucose results $< 75\mathrm{mg / dL}$ | Within ± 5 mg/dL | Within ± 10 mg/dL | Within± 15 mg/dL | | --- | --- | --- | | 8 / 13 (61.5 %) | 13 / 13 (100 %) | 13 / 13 (100 %) | Glucose results $\geq 75\mathrm{mg / dL}$ | Within ± 5% | Within ± 10% | Within± 15% | Within ± 20% | | --- | --- | --- | --- | | 80 / 147 (54.4 %) | 134 / 147 (91.2 %) | 145 / 147 (98.6 %) | 147 / 147 (100 %) | # AST (palm): Glucose results $< 75\mathrm{mg / dL}$ | Within ± 5 mg/dL | Within ± 10 mg/dL | Within± 15 mg/dL | | --- | --- | --- | | 4 / 7 (57.1 %) | 7 / 7 (100 %) | 7 / 7 (100 %) | Glucose results $\geq 75\mathrm{mg / dL}$ | Within ± 5% | Within ± 10% | Within± 15% | Within ± 20% | | --- | --- | --- | --- | | 77 / 139 (55.4 %) | 110 / 139 (79.1 %) | 129 / 139 (92.8 %) | 137 / 139 (98.6 %) | # b. Matrix comparison: Not applicable. {10} 11 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): To evaluate the accuracy of the GLUCOCARD 01/ReliOn Confirm blood glucose monitoring systems in the hands of the intended user population, the sponsor performed a study with 150 adult lay user participants. Each participant was given either a GLUCOCARD 01 or ReliOn Confirm blood glucose meter and the corresponding Instruction Manual and Quick Reference Guide. Participants were asked to perform a self-test of fresh capillary blood drawn from the fingertip and one alternate site (palm) using the same system. Three lots of GLUCOCARD 01 SENSOR PLUS test strips were used. Test results from two participants were excluded due to out-of-range hematocrit values. The fingertip data were included in the analyses. Results were analyzed by comparing blood glucose results from the GLUCOCARD 01/ReliOn Confirm blood glucose monitoring system obtained by the lay user against the reference value (YSI) obtained by professional users. Two YSI Model 2300 Analyzers were used to determine the reference glucose values for each participant. The results are summarized in the tables below: Fingertip: Glucose results < 75 mg/dL | | Within ± 5 mg/dL | Within ± 10 mg/dL | Within ± 15 mg/dL | | --- | --- | --- | --- | | Lay User | 6 / 7 (85.7 %) | 7 / 7 (100.0 %) | 7 / 7 (100.0 %) | Glucose results ≥ 75 mg/dL | | Within ± 5% | Within ± 10% | Within± 15% | Within ± 20% | | --- | --- | --- | --- | --- | | Lay User | 84/141 (59.6%) | 122/141 (86.5%) | 136/141 (96.5%) | 141/141 (100.0%) | Linear regression fingertip - lay users (all lots) | Line Equation | 95% CI Slope | 95% CI Intercept | Correlation Coefficient (r) | N | | --- | --- | --- | --- | --- | | y = 0.99x + 0.65 | 0.96 to 1.01 | -4.06 to 5.37 | 0.986 | 148 | {11} 12 AST (palm): Glucose results < 75mg/dL | Within ± 5 mg/dL | Within ± 10 mg/dL | Within± 15 mg/dL | | --- | --- | --- | | 5 / 7 (71.4 %) | 7 / 7 (100 %) | 7 / 7 (100 %) | Glucose results ≥75 mg/dL | Within ± 5% | Within ± 10% | Within± 15% | Within ± 20% | | --- | --- | --- | --- | | 70 / 140 (50.0 %) | 118 / 140 (84.3 %) | 130 / 140 (92.9 %) | 133 / 140 (95.0 %) | Linear regression AST - lay users (all lots) | Line Equation | 95% CI Slope | 95% CI Intercept | Correlation Coefficient (r) | N | | --- | --- | --- | --- | --- | | y = 1.03x - 1.34 | 1.00 to 1.07 | -7.19 to 4.51 | 0.981 | 147 | 4. Clinical cut-off: Not applicable. 5. Expected values/Reference range: In the labeling, expected blood glucose levels for people without diabetes (referenced from American Diabetes Association Standards of Care, 2013) are presented as follows: Fasting and before meals <100 mg/dL 1-2 hours after meals <140 mg/dL N. Instrument Name: ARKRAY GLUCOCARD™ 01 Blood Glucose Meter ReliOn Confirm Blood Glucose Meter O. System Descriptions: 1. Modes of Operation: Each test strip is single use and must be replaced with a new strip for each additional reading. Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? {12} 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: 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: The glucose test is intended to be used with capillary whole blood from the finger and palm only. The whole blood sample is applied directly to the test strip by capillary action. 5. Calibration: The system is designed to be non-coding. The test strips are coded with a test strip lot-specific code. When the test strip is inserted into the meter it provides the appropriate calibration code information to the meter, therefore, the user is not required to enter any coding information. 6. Quality Control: The sponsor manufactures three levels of glucose control solution, L1, L2, and L3 to be used with the GLUCOCARD™ 01 Blood Glucose Monitoring System and the ReliOn Confirm Blood Glucose Monitoring System. The L2 Control is included only in the System Kit for the GLUCOCARD™ 01 Blood Glucose Monitoring System. Otherwise, these control solutions must be purchased separately. Instructions for how to purchase the control solution are provided in the user manuals. An acceptable range for each control level is printed on the test strip vial label. If the control values fall outside these ranges, the user is referred to the user manual and customer support for assistance. 13 {13} P. Other Supportive Instrument Performance Characteristics Data Not Covered In the "Performance Characteristics" Section above: 1. Software documentation: The following documentations related to the software were reviewed and found to be acceptable. The firm provided documentation to support the device was designed, developed and is under good software lifecycle processes. - Level of Concern - Software Description - Device Hazard Analysis - (Risk Management Report) - System Requirement - Specification (SRS) - Architecture Design Chart - Software Design - Specification (SDS) - Traceability Analysis - Software Development - Environment Description - Verification and Validation - Documentation - Revision Level History 2. Data transmission: The sponsor stated that the meter allows data transmission to/from a computer via a serial cable. The meter hardware and software has not been modified since k073416. 3. Hematocrit Study: The effect of different hematocrit levels was evaluated with three lot of test strips. Blood samples at eight concentrations ranging from 30.2 to 425.8 mg/dL were analyzed. The glucose samples were prepared from venous blood at eight different hematocrit levels; 20, 30, 35, 42, 45, 50, 55, and 60%. Glucose results for each concentration and hematocrit level were compared to samples tested on the YSI reference method. The biases relative to YSI for 30-55% hematocrit sample met the sponsor's acceptance criteria and supports the sponsor's claim that hematocrit in the range of 30-55% does not significantly interfere with glucose measurements. 4. Altitude Study: An altitude study was conducted to evaluate the effect of altitude up to 10,000 feet on performance of the blood glucose monitoring system. Venous whole blood samples at four glucose concentrations approximately 60, 150, 300, and 450 mg/dL were tested on one lot of test strips. Each sample was also evaluated by the YSI method. The results met the sponsor's acceptance criteria and demonstrated that the performance of the GLUCOCARD 01/ReliOn Confirm System with the new GLUCOCARD 01 SENSOR PLUS is not affected by altitude up to 10,000 feet. 5. Environmental conditions: {14} Studies were performed to verify the operational limitations of the system with glucose concentrations of approximately 67, 134, and 336 mg/dL. Testing was performed at five combined temperature and humidity conditions (10°C/20% RH, 10°C/80% RH, 25°C/50% RH, 40°C/20% RH and 40°C/80% RH) and results compared to the reference YSI. Five measurements were then taken at each glucose level, with three test strip lots, for a total of 45 determinations. The results met the sponsor’s acceptance criteria and demonstrated that the test system can be used at temperatures from 10 -40°C and at a relative humidity from 20-80%. 6. Sample volume study: A sample volume study was performed to establish the minimum sample volume requirement for the GLUCOCARD 01 and ReliOn Confirm meters. Venous blood from donors was collected into sodium heparin tubes. The glucose level was adjusted to approximately 50, 130 and 300 mg/dL. The study evaluated 15 sample volumes ranging from 0.15 μL to 10 μL with twelve GLUCOCARD 01 meters. Six meters were used to collect ‘control’ volume data (1 μL) and six others were used for the ‘test’ sample volumes. For each test volume, blood glucose concentrations were determined using three test strip lots at three glucose levels. Reference measurements were taken at the start and end of each test series using a YSI Model 2300. Sample volumes were tested in random order. All tests of the 0.15 μL volume series yielded “E-7” errors indicating there was insufficient sample volume to perform the test. The meters reported glucose reading for all samples with a volume ≥ 0.2 μL and the bias relative the average YSI reference met the acceptance criteria. The sample volume study supports the minimum sample volume claim of as 0.3 μL. 7. User performance study: During the lay user study described above in Section M.3.c, the participants were asked to complete a questionnaire to evaluate the ease of use of the device and the clarity of the English language labeling. Overall the users indicated that they could successfully perform the test and that the user manual was written clearly. 8. Readability Assessment: The readability of the labeling (user guide and test strip insert) using a Flesch-Kincaid analysis were found to be written at the 8th grade level. 9. EMC Testing: EMC testing was conducted in accordance to EN 60601-1-2, EN 61326, IEC 61326, EN 55011, and EN 61000-6-1 and the certification was provided. 10. Customer Care Service Center is available 24 hours a day, 7 days a week by calling 800-266-8558 for the ARKRAY GLUCOCARD 01 meter, or by calling 855-776-0662 for the ReliOn Confirm meter. 11. Infection Control: ARKRAY GLUCOCARD™ 01 Blood Glucose Monitoring System and ReliOn Confirm Blood Glucose Monitoring System are intended for single-patient use. Disinfection 15 {15} efficacy studies were performed using constituent surface materials of the GLUCOCARD 01 meter and the ReliOn Confirm Blood Glucose Metersby an outside commercial testing lab demonstrating complete inactivation of duck hepatitis B Virus (DHBV) with the chosen disinfectant, Clorox Germicidal Wipes (EPA Reg. No: 67619-12). Robustness studies were also performed by the sponsor demonstrating that there was no change in performance or external materials of the meter after 416 cleaning and disinfection cycles, using Clorox Germicidal Wipes, to simulate 4 years of single-patient use. Labeling has been reviewed for adequate instructions in validated cleaning and disinfection procedures. 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. 16