SUPERCHECK PLUS BLOOD GLUCOSE MONITORING SYSTEM, SUPER CHECK PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM

{0} 1 # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k141351 B. Purpose for Submission: New device C. Measurand: Capillary whole blood glucose from the fingertip and forearm, and venous whole blood glucose D. Type of Test: Quantitative Amperometric assay (flavin adenine dinucleotide-glucose dehydrogenase (GDH-FAD)) E. Applicant: Biotest Medical Corp. F. Proprietary and Established Names: SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M) G. Regulatory Information: | Product Code | Classification | Regulation Section | Panel | | --- | --- | --- | --- | | LFR | II | 21 CFR 862.1345 - Glucose test system, Glucose dehydrogenase, Glucose | Chemistry (75) | | NBW | II | 21 CFR 862.1345 - System, Test, Blood Glucose, Over the Counter | Chemistry (75) | | JJX | I, reserved | 21 CFR 862.1660 – Quality Control Material (assayed and unassayed) | Chemistry (75) | {1} H. Intended Use: 1. Intended use(s): See Indications for use below. 2. Indication(s) for use: The SuperCheck Plus Blood Glucose Monitoring System The SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or forearm. The SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) is intended to be used by a single person and should not be shared. The SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. The SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly). The SuperCheck Plus Test Strips are for use with the SuperCheck Plus Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips or forearm. The SuperCheck Plus Control Solutions are for use with the SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) as a quality control check to verify that the meter and test strips are working together properly. The SuperCheck Plus Multi Blood Glucose Monitoring System The SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M) is composed of the SuperCheck Plus Multi Test Strips and SuperCheck Plus Multi Blood Glucose Meter and is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from fingertips or forearm, or in venous whole blood. The SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M) is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in a professional healthcare setting as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, auto-disabling lancets. The SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M) should {2} not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly). The SuperCheck Plus Multi Test Strips are for use with the SuperCheck Plus Multi Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood drawn from fingertips or forearm, or in venous whole blood. The SuperCheck Plus Multi Control Solutions are for use with the SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M) as a quality control check to verify that the meter and test strips are working together properly.3. 3. Special conditions for use statement(s): - For in vitro diagnostic use only - The single-patient use system is for single-patient use only and should not be shared - The multiple-patient use system should only be used with single-use, auto-disabling lancing devices - Not for neonatal use - Do not use for diagnosis of or screening for diabetes mellitus - Not for use on critically ill patients, patients in shock, dehydrated patients or hyper-osmolar patients - Alternative site testing (AST) should only be performed during periods of steady-state blood glucose conditions (when glucose is not changing rapidly) - AST measurements should not be used for calibrating Continuous Glucose Monitors (CGM) - AST measurements should not be used in insulin dose calculations 4. Special instrument requirements: SuperCheck Plus Glucose Meter, SuperCheck Plus Multi Glucose Meter I. Device Description: The SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) is for single patient use only and the SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M) is for multiple patient use. Both systems consist of a blood glucose meter, test strips, Level II control solution, and instructions for use (labeling). The SuperCheck Plus Blood Glucose Monitoring System for single patient use includes a lancing device and lancets. The SuperCheck Plus and SuperCheck Plus Multi Control Solutions are for use with the SuperCheck Plus and SuperCheck Plus Multi Blood Glucose Monitoring Systems as a quality control check to verify that the meter and test strips are working together properly. The Level II control is provided with the kit; Levels I and III can be purchased separately. {3} A data download functionality consisting of software and cord is available as an option for users and sold separately. J. Substantial Equivalence Information: 1. Predicate device name(s): ACCU-CHEK Performa System 2. Predicate 510(k) number(s): k070585 3. Comparison with predicate: 4 {4} SuperCheck Plus Blood Glucose Monitoring System(Model 5228-S) (single patient use) | Similarities | | | | --- | --- | --- | | Item | Device | Predicate | | | SuperCheck Plus Blood Glucose Monitoring System(Model 5228-S) (k141351) | ACCU-CHEK Performa System (k070585) | | Enzyme | FAD- glucose dehydrogenase | Glucose dehydrogenase with nitrosoaniline mediator | | Measurement principle | Same | Amperometric method | | Intended use | Same | It is intended for quantitative measurement of glucose in fresh capillary blood by people with diabetes as an aid to monitor the effectiveness of a diabetes control program. | | Sample type | Same | Fresh capillary whole blood Venous whole blood | | Power | Same | Two 1.5V AAA alkaline batteries | | Glucose units | Same | Either mg/dL or mmol/L | | Strip vial open time | Same | 90 days | | Test time | Same | 5 seconds | | Memory | Same | 500 measurements with day and time | | PC link | Same | Yes | 5 {5} | Differences | | | | --- | --- | --- | | Item | Device | Predicate | | | SuperCheck Plus Blood Glucose Monitoring System(Model 5228-S) (k141351) | ACCU-CHEK Performa System (k070585) | | Weight | 72g | 62g | | Dimensions | 100mm(L)x50mm(W)x20mm(H) | 93mm(L)x52mm(W)x22mm(H) | | Test volume | 1.1μL | 0.6μL | | Test Range | 20-600 mg/dL | 10-600 mg/dL | | Operating condition | 10~40°C(50-104°F) 20~80% RH (non-condensing) | 6~44°C(39.2-111.2°F) 10~90% RH | | Strip storage condition | 2~30°C(35.6-86°F), below80% RH | 2~30°C(35.6-86°F) | | Alternate site capability | Forearm | Palm, forearm, upper arm, thigh, and calf | | Hematocrit range | 20-60% | 10-70% | | Coding | No | Yes (A Code Key is provided with each box of test strips to calibrate the meter for that strip lot.) | {6} SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M) (multiple patient use) | Similarities | | | | --- | --- | --- | | Item | Device | Predicate | | | SuperCheck Plus Multi Blood Glucose Monitoring System(Model 5228-S) (k141351) | ACCU-CHEK Performa System (k070585) | | Enzyme | FAD- glucose dehydrogenase | Glucose dehydrogenase with nitrosoaniline mediator | | Measurement principle | Same | Amperometric method | | Intended use | Same | It is intended for quantitative measurement of glucose in fresh capillary blood by people with diabetes as an aid to monitor the effectiveness of a diabetes control program. | | Sample type | Same | Fresh capillary whole blood Venous whole blood | | Power | Same | Two 1.5V AAA alkaline batteries | | Glucose units | Same | Either mg/dL or mmol/L | | Strip vial open time | Same | 90 days | | Test time | Same | 5 seconds | | Memory | Same | 500 measurements with day and time | | PC link | Same | Yes | 7 {7} | Differences | | | | --- | --- | --- | | Item | Device | Predicate | | | SuperCheck Plus Multi Blood Glucose Monitoring System(Model 5228-S) (k141351) | ACCU-CHEK Performa System (k070585) | | Weight | 72g | 62g | | Dimensions | 100mm(L)x50mm(W)x20mm(H) | 93mm(L)x52mm(W)x22mm(H) | | Test volume | 1.1μL | 0.6μL | | Test Range | 20-600 mg/dL | 10-600 mg/dL | | Operating condition | 10~40°C(50-104°F) | 6~44°C(39.2-111.2°F) | | | 20~80% RH (non-condensing) | 10~90% RH | | Strip storage condition | 2~30°C(35.6-86°F), below80% RH | 2~30°C(35.6-86°F) | | Alternate site capability | Forearm | Palm, forearm, upper arm, thigh, and calf | | Hematocrit range | 20-60% | 10-70% | | Coding | No | Yes (A Code Key is provided with each box of test strips to calibrate the meter for that strip lot.) | K. Standard/Guidance Document Referenced (if applicable): - CLSI EP6-A Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline - CLSI EP7-A2: Interference Testing in the Clinical Laboratory; Approved Guideline - IEC 61000-4-2 Electromagnetic compatibility (EMC) – Part 4-2: Testing and measurement techniques - IEC 61000-4-3: Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test - IEC 61000-4-8: Electromagnetic Compatibility (EMC) - Part 4-8: Testing and Measurement Techniques - Power Frequency Magnetic Field Immunity Test - IEC 61010-1: 2001 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements {8} - 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. - IEC 61326-1: 2006 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements - IEC 61326-2-6: 2006 Electrical equipment for measurement, control and laboratory use. EMC requirements. Particular requirements. In vitro diagnostic (IVD) medical equipment - ISO 14971: 2007 Medical devices- Application of risk management to medical devices. - ISO 23640 In vitro diagnostic medical devices -- Evaluation of stability of in vitro diagnostic reagents - CISPR 11 Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement ## L. Test Principle: The test principle for the SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) and SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M) is an amperometric method that uses flavin adenine dinucleotide-glucose dehydrogenase (GDH-FAD) enzyme chemistry. The reaction utilizes the oxidation of glucose by the dehydrogenase enzyme and then yields electrons, which can be used to generate an electric signal that is measured by the meter, and after calculation by the meter, the blood glucose concentration reading is displayed, calibrated to plasma reference. The strength of the current produced by the reaction depends on the amount of glucose in the blood sample. ## M. Performance Characteristics (if/when applicable): ### 1. Analytical performance: All performance characteristics were conducted on the SuperCheck Plus BGMS. Testing performed on the SuperCheck Plus BGMS to characterize the performance of the SuperCheck Plus Multi BGMS is adequate since both the SuperCheck Plus and SuperCheck Plus Multi BGMS are identical with the exception of the names and intended use (i.e. single vs. multiple patient use). #### a. Precision/Reproducibility: Repeatability was performed using 5 venous blood samples drawn in heparin tubes and adjusted to five targeted glucose concentrations by addition of glucose in saline or by glycolysis. Each sample was tested 10 times on three test strips lots, using 30 meters (10 meters per test strip lot). Results are summarized below: {9} | Repeatability precision (whole blood) | | | | | | | --- | --- | --- | --- | --- | --- | | Target Glucose Level (mg/dL) | n | Strip Lot | Mean (mg/dL) | SD (mg/dL) | CV (%) | | 30-50 | 100 | 1 | 46 | 2.13 | 4.63 | | | 100 | 2 | 48 | 2.14 | 4.46 | | | 100 | 3 | 48 | 2.17 | 4.52 | | 51-110 | 100 | 1 | 85 | 2.93 | 3.45 | | | 100 | 2 | 83 | 2.93 | 3.53 | | | 100 | 3 | 86 | 2.93 | 3.41 | | 111-150 | 100 | 1 | 123 | 3.82 | 3.11 | | | 100 | 2 | 124 | 3.93 | 3.17 | | | 100 | 3 | 120 | 3.84 | 3.20 | | 151-250 | 100 | 1 | 245 | 7.15 | 2.92 | | | 100 | 2 | 250 | 6.99 | 2.80 | | | 100 | 3 | 247 | 7.04 | 2.85 | | 251-400 | 100 | 1 | 390 | 9.08 | 2.33 | | | 100 | 2 | 389 | 8.88 | 2.28 | | | 100 | 3 | 385 | 8.92 | 2.32 | Intermediate precision evaluation was performed on control materials at 3 different glucose concentrations (30-50mg/dL, 96-144mg/dL and 280-420mg/dL) with 3 lots of test strips and 10 meters for 10 days. Results are summarized below: | Intermediate precision (whole blood) | | | | | | | --- | --- | --- | --- | --- | --- | | Target Glucose Level (mg/dL) | n | Strip Lot # | Mean (mg/dL) | SD (mg/dL) | CV (%) | | 30-50 | 100 | 1 | 43 | 2.00 | 4.65 | | | | 2 | 44 | 1.90 | 4.32 | | | | 3 | 42 | 1.91 | 4.55 | | 96-144 | 100 | 1 | 123 | 3.86 | 3.14 | | | | 2 | 123 | 3.94 | 3.20 | | | | 3 | 124 | 3.95 | 3.19 | | 280-420 | 100 | 1 | 356 | 8.53 | 2.40 | | | | 2 | 361 | 8.84 | 2.45 | | | | 3 | 358 | 8.87 | 2.48 | # b. Linearity/assay reportable range: The linearity study was performed using adjusted venous whole blood samples with 11 different glucose concentration levels across the measuring range of 20 - 600 mg/dL (21, 81, 140, 191, 248, 306, 361, 420, 476, 531, 592 mg/dL). The study was {10} performed with 3 lots of test strips and 10 meters. Measurements of the same samples by YSI glucose analyzer were used as a reference. Linear regression analysis for each test strip lot compared to the YSI resulted in: | Strip lot | Linear Regression | R² | | --- | --- | --- | | Lot. #1 | y=0.9931x+1.5695 | 0.9994 | | Lot. #2 | y=0.9950x+1.3617 | 0.9997 | | Lot. #3 | y=0.9901x+1.6620 | 0.9997 | | Combined | y=0.9930x+1.5106 | 0.9998 | The study results support the claimed measuring range of 20-600 mg/dL of the SuperCheck Plus (5228-S) and SuperCheck Plus Multi (5228-M) Blood Glucose Monitoring Systems. c. Traceability, Stability, Expected values (controls, calibrators, or methods): ## Traceability The SuperCheck Plus Blood Glucose Monitoring System is traceable to the NIST SRM917A reference material. The reference instrument used is the YSI Model 2300 Glucose Analyzer. ## Test Strip Stability Closed-vial (shelf life) stability and opened-vial (in-use) stability studies were performed to evaluate the stability of test strips. Closed-vial studies were conducted for 5 months shelf-life for the real-time test and are ongoing. Opened-vial was performed for 90 days. Closed-vial and opened-vial stability studies were carried out at 2°C - 30°C and relative humidity of 20% to 80%. The results presented that the test strips are stable when stored at the recommended conditions for 90 days after first opening and have a 5 month shelf life. ## Value Assignment: The control materials are assigned a YSI2300 calibrated to a solution traceable to NIST SRM 917. The control solutions are evaluated by multiple replicates on the YSI2300. Then, five vials per lot of the controls are evaluated on 15 SuperCheck Plus meters. An average of the measurements is used to assign the value of the controls. The protocol and acceptance criteria were reviewed and found to be adequate. d. Detection limit: The reportable range is 20 to 600 mg/dL based on linearity studies (see section M.1.b). {11} # e. Analytical specificity: To assess potential interference venous whole blood samples were adjusted to two glucose concentration intervals of 50 to $100\mathrm{mg / dL}$ and $250 - 350\mathrm{mg / dL}$ (as measured on the YSI 2300 Analyzer). Each of these samples was divided into a test pool and a control pool and each of the potential endogenous and exogenous interfering substances was added to the test pool. Each substance was tested at a minimum of two concentrations, normal/therapeutic and high/toxic concentrations. The $\%$ difference between the test sample and the control sample was calculated. Results are presented in the table below: | Interfering substances | Highest concentration at which no interference is observed | | --- | --- | | Endogenous substances | | | Bilirubin | 20.8 mg/dL | | Cholesterol | 648.1 mg/dL | | Creatinine | 5.95 mg/dL | | Fructose | 30 mg/dL | | Galactose | 60 mg/dL | | Glutathione | 23.5 mg/dL | | Glyceryl Tributyrate | 200 mg/dL | | Hemoglobin | 20 g/dL | | Triglycerides | 3,000 mg/dL | | Uric Acid | 9.5 mg/dL | | Exogenous substances | | | Acetaminophen | 20 mg/dL | | Ascorbic Acid | 4.5 mg/dL | | Dopamine | 1.25 mg/dL | | Gentistic acid | 6.75 mg/dL | | Ibuprofen | 50 mg/dL | | L-Dopa | 1.9 mg/dL | | Maltose | 1000 mg/dL | | Methyl Dopa | 1.5 mg/dL | | Pralidoxime Iodide(PAM) | 62.5 mg/dL | | Salicylate | 115.5 mg/dL | | Tolazamide | 3.8 mg/dL | | Tolbutamide | 64 mg/dL | | Xylose | 6.3 mg/dL | The labeling contains the following limitations regarding interference: Hematocrit in the range of $20\sim 60\%$ does not affect the glucose results. Cholesterol level up to $500\mathrm{mg / dL}$ and Triglycerides up to $3,000\mathrm{mg / dL}$ have been {12} shown not to affect glucose results. Interference was observed for therapeutic levels of Glutathione. Certain substances occurring in the body naturally, such as uric acid, or from normal therapeutic treatments (Ascorbic acid, L-Dopa, Tolazamide and Gentisic acid) will not significantly affect results. However, higher concentrations in blood may cause incorrect results. There is no significant interference in the presence of galactose, maltose or fructose observed in blood glucose test. Do not test blood glucose during or soon after xylose absorption test. Xylose in the blood can give falsely elevated results. f. Assay cut-off: Not applicable. 2. Comparison studies: a. Method comparison with predicate device: System accuracy: To assess system accuracy, fingertip samples and forearm samples were collected from 151 subjects and compared to a reference method, YSI 2300. Trained healthcare professionals at each site performed testing on blood obtained from the finger and forearm from each participant. In order to obtain samples at the lowest and highest glucose concentrations, nine fresh capillary blood samples from individual participants were altered to achieve the desired distribution, 4 at the low range (< 50 mg/dL) and 3 at the high range (> 400 mg/dL). Six meters and 3 lots of test strips were used in the study. System accuracy results for glucose concentration < 75 mg/dL | Sample site | Within ± 5 mg/dL | Within ± 10 mg/dL | Within ± 15 mg/dL | | --- | --- | --- | --- | | Fingertip | 6/9 (66.7%) | 9/9 (100%) | 9/9 (100%) | | Forearm | 6/9 (66.7%) | 9/9 (100%) | 9/9 (100%) | {13} System accuracy results for glucose concentration $\geq 75\mathrm{mg / dL}$ | Sample site | Within ± 5% | Within ± 10% | Within ± 15% | Within ± 20% | | --- | --- | --- | --- | --- | | Fingertip | 105/140 (75.0%) | 136/140 (97.1%) | 139/140 (99.3%) | 140/140 (100%) | | Forearm | 95/140 (67.9%) | 128/140 (91.4%) | 139/140 (99.3%) | 139/140 (99.3%) | Regression between BGMS results and the YSI 2300 for the capillary blood samples: | Sample site | Slope | Intercept | R2 | | --- | --- | --- | --- | | Fingertip | 1.0039 | 1.1198 | 0.9950 | | Forearm | 1.0087 | -0.6096 | 0.9902 | # b. Matrix comparison: Healthcare professionals collected venous blood samples from 112 participants into Heparin-containing tubes. The venous blood samples were tested with the BGMS and measured by the YSI 2300. Blood glucose concentrations measured on the YSI 2300 ranged from 23 to $498\mathrm{mg / dL}$ . The data analysis and linear regression of the results are summarized below: System accuracy results for glucose concentration $< 75\mathrm{mg / dL}$ | Sample site | Within ± 5 mg/dL | Within ± 10 mg/dL | Within ± 15 mg/dL | | --- | --- | --- | --- | | Venous blood | 8/11 (72.7%) | 10/11 (90.9%) | 11/11 (100%) | System accuracy results for glucose concentration $\geq 75\mathrm{mg / dL}$ | Sample site | Within ± 5% | Within ± 10% | Within ± 15% | Within ± 20% | | --- | --- | --- | --- | --- | | Venous blood | 84/101 (83.2%) | 98/101 (97.0%) | 101/101 (100%) | 101/101 (100%) | Regression between system results and the YSI 2300 for the venous blood samples: | Slope | Intercept | R2 | | --- | --- | --- | | 1.0011 | -1.3618 | 0.9945 | Healthcare professionals collected capillary whole blood samples from 100 participants into Heparin-containing tubes and EDTA anticoagulated tubes. The samples collected in the EDTA tubes were tested with the BGMS and the samples {14} collected in the heparin tubes were measured by YSI 2300. Blood glucose concentrations measured on the YSI 2300 ranged from 23 to 498 mg/dL. The data analysis and linear regression of the results are summarized below: Results for samples with glucose concentrations < 75 mg/dL: | Compared to YSI | Within ± 5 mg/dL | Within ± 10 mg/dL | Within ± 15 mg/dL | | --- | --- | --- | --- | | EDTA | 10/12 (83.3%) | 11/12 (91.7%) | 12/12 (100%) | Results for samples with glucose concentrations ≥ 75 mg/dL: | Compared to YSI | Within ± 5% | Within ± 10% | Within ± 15% | Within ± 20% | | --- | --- | --- | --- | --- | | EDTA | 71/88 (80.7%) | 85/55 (96.6%) | 88/88 (100%) | 88/88 (100%) | Linear regression analysis between system results and the YSI2300 for EDTA samples: | Compared to YSI | Slope | y-intercept | R² | | --- | --- | --- | --- | | | 1.0157 | -1.5437 | 0.9866 | 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 study: The study was performed at one site with 129 participants to demonstrate lay user self-test results performed using the SuperCheck Plus (Model 5228-S) BGMS and SuperCheck Plus Multi BGMS (Model 5228-M). All participants were given the user manual in English with no further information or training provided. Participants were asked to perform testing using the glucose meter. A technician then collected capillary blood from each participant for measurement on the meter and YSI. The glucose concentration range of the samples tested on YSI 2300 was 39.9 to 587 mg/dL. The results relative to YSI 2300 are summarized in the table below: {15} System accuracy results for glucose concentration $< 75\mathrm{mg / dL}$ | Sample site | Within ± 5 mg/dL | Within ± 10 mg/dL | Within ± 15 mg/dL | | --- | --- | --- | --- | | Fingertip | 1/4 (25.0%) | 4/4 (100%) | 4/4 (100%) | | Forearm | 2/4 (50%) | 3/4 (75%) | 4/4 (100%) | System accuracy results for glucose concentration $\geq 75\mathrm{mg / dL}$ | Sample site | Within ± 5% | Within ± 10% | Within ± 15% | Within ± 20% | | --- | --- | --- | --- | --- | | Fingertip | 64/125 (51.2%) | 110/125 (88.0%) | 125/125 (100%) | 125/125 (100%) | | Forearm | 69/125 (55.2%) | 106/125 (84.8%) | 122/125 (97.6%) | 124/125 (99.2%) | Regression between BGMS results and the YSI 2300 for the capillary blood samples: | Sample site | Slope | Intercept | R2 | | --- | --- | --- | --- | | Fingertip | 0.9827 | 7.9805 | 0.9861 | | Forearm | 0.9822 | 7.0568 | 0.9843 | A usability study was performed to assess the readability of the labeling for the US market by surveying the 129 lay users (aged 24-88 yrs old) that participated in the accuracy study. Participants varied in age, education, and it was fairly distributed between $(49\%)$ and women $(51\%)$ . These lay users completed a questionnaire in 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. The majority of the users responded that the device is very easy to use. # 4. Clinical cut-off: Not applicable. # 5. Expected values/Reference range: Expected plasma blood glucose values for normal, nondiabetic adults are as follows: Before eating $< 100\mathrm{mg / dL}$ Two hours after meals $< 140\mathrm{mg / dL}$ American Diabetes Association: Diabetes Care, January 2015, volume 38 (Suppl. 1) S8-S16. {16} 17 N. Instrument Name: SuperCheck Plus blood glucose meter and BTM Glucose Meter Data Download Software O. System Descriptions: 1. Modes of Operation: Each test strip is single use and requires a sample volume of 0.7 mL. Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? ☑ Yes ☐ X or No Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? ☐ Yes ☐ or No ☑ X 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. As the blood sample was collected from the fingertip or forearm, the user directly applies the blood sample to the test strip. In the BTM Glucose Meter Data Download Software, the sample is identified only by date and time of testing. 4. Specimen Sampling and Handling: The SuperCheck Plus (5228-S) and SuperCheck Plus Multi (5228-M) Glucose Meters are used for measuring with fresh capillary whole blood samples from the finger, forearm and also venous blood. The whole blood sample is applied directly to the test strip by capillary action. 5. Calibration: {17} The SuperCheck Plus (5228-S) and SuperCheck Plus Multi (5228-M) Glucose Meters are automatically coded. 6. Quality Control: SuperCheck Plus Glucose Control Solution and SuperCheck Plus Multi Glucose Control Solution are intended for quality control of SuperCheck Plus (5228-S) and SuperCheck Plus Multi (5228-M) Blood Glucose Monitoring Systems respectively. Three levels of aqueous glucose solutions (I, II, III) are available; the medium level is included with the kit and the low and high levels can be purchased separately. An acceptable range for each control level is printed on the test strip vial label. Recommendations on when to test the control materials are provided in the labeling and what the user should do if the control result falls outside these ranges. P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above: 1. Hematocrit Study - The sponsor performed hematocrit studies using eight different hematocrit (Hct) levels (20, 25, 30, 35, 42, 50, 55, 60%) across the glucose measuring range (20-600 mg/dL). At each hematocrit level, 3 samples at glucose concentrations of approximately 45, 125, and, 355 mg/dL were tested against the YSI method. 3 lots of test strips were tested on 12 meters and the values were compared to the YSI method and the nominal hematocrit level (42%). The results demonstrated that the device produces accurate results over the claimed hematocrit range of 20% to 60%. 2. Altitude Study - A study was conducted to evaluate the effect of altitude on the SuperCheck Plus BGMS. 3 lots of test strips were tested on 10 meters using blood from venous blood samples obtained from three donors spiked to three glucose concentrations (47 mg/dL, 135 mg/dL, 371 mg/dL). Samples were tested at ground level and at 10,744 feet above sea level. Each venous blood sample was also tested by the YSI 2300 analyzer. The meter readings obtained were compared to the YSI method and the percent bias against the YSI results. The results support the sponsor's claim that the SuperCheck Plus BGMS can be used at altitude up to 10,744 feet. 3. Sample volume study: A minimum sample volume study was performed to verify the minimum test strip sample volume requirement and the test strip fill error function established for the SuperCheck Plus BGMS. Three lots of test strips on 30 meters were tested using blood from six donors. Blood at each concentration was applied to strips at five target sample volumes of 0.5, 0.6, 0.7, 0.8, 1.0, 2.0 and 3.0 µL. Protocols and acceptance criteria were provided and found to be acceptable. The study results supported the Sponsor's claim that a minimum sample volume of ≥ 0.7 µL produced accurate results and all samples < 0.7 µL give an error code and do not provide results to the user. 4. Temperature and humidity studies: Temperature and humidity operating conditions were evaluated for temperatures ranging from 10°C to 40°C (50°F – 104°F) and relative humidity from 20% to 80%. Three lots of test strips on 30 meters were tested using three whole blood samples at three glucose concentration levels. The 18 {18} results supported the Sponsor's claimed operating conditions from 10°C to 40°C (50°F to 104°F) and 20-80% RH. 5. Infection control studies: The device is intended for single-patient use and multiple-patient use. Disinfection efficacy studies were performed on the external meter materials demonstrating removal of the HBsAg antigen with the chosen disinfectant, Clorox Bleach Germicidal Wipes (EPA Registration #67619-12). Robustness studies were also performed by the sponsor demonstrating that there was no change in performance or in the external materials of the meter and lancing device after 11,000 cleaning cycles and 11,000 disinfection cycles designed to simulate 3 years of device use. Labeling 6. EMC Testing: EMC testing was evaluated and certified by Precision Machinery Research and Development Center; test reports were submitted certifying that acceptable electromagnetic testing (EMC) had been performed. 7. Readability Assessment: Flesch-Kincaid readability assessment was conducted and the results showed that the labeling (Owner's Guide, test strip package insert and control solution package insert) were written at the 8th grade level. 8. Customer support: Customer service is available 9AM – 5PM EST Monday through Friday. Toll free phone number is 1-888-887-4772 for customer support. 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. 19