MEG-2 BLOOD GLUCOSE MONITORING SYSTEM, MEG-2 50'S TEST STRIP, MEG-2 CONTROL SOLUTION

{0} 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k101204 B. Purpose for Submission: New device C. Measurand: Capillary whole blood glucose D. Type of Test: Quantitative, amperometric assay, glucose oxidase E. Applicant: Apex Biotechnology Corporation F. Proprietary and Established Names: MEG-2 Blood Glucose Monitoring System MEG-2 Blood Glucose Test Strips MEG-2 Multi Blood Glucose Monitoring System MEG-2 Multi Blood Glucose Test Strips MEG-2 Glucose Control Solution 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, Class I (reserved) 3. Product code: NBW, System, Test, Blood Glucose, Over The Counter CGA, Glucose Oxidase, Glucose JJX, Quality Control Material {1} Page 2 of 15 4. Panel: Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): See Indications for Use below. 2. Indications(s) for use: MEG-2 Blood Glucose Monitoring System The MEG-2 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. 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. This system should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use. Alternative site testing can be used only during steady-state blood glucose conditions. MEG-2 Blood Glucose Test Strips The MEG-2 Blood Glucose Test Strips are to be used with the MEG-2 Blood Glucose Meter; it measures glucose in capillary whole blood taken from a fingertip, palm, or forearm. It is for use outside of body (in vitro diagnostic use). It is intended for lay use by people with diabetes and should only be used by a single patient. This system should not be shared. They are not indicated for the diagnosis or screening of diabetes or for neonatal use. MEG-2 Multi Blood Glucose Monitoring System The MEG-2 Multi Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood sample drawn from the fingertips, forearm, or palm. Testing is done outside the body (In Vitro Diagnostic use). It is indicated to be used for multiple patients in a clinical setting by healthcare professionals, as an aid to monitoring levels in Diabetes Mellitus. This system is only used with single-use, auto-disabling lancing device. It is not indicated for the diagnosis or screening of diabetes or for neonatal use. Alternative site testing can be used only during steady-state blood glucose conditions. MEG-2 Multi Blood Glucose Test Strips The MEG-2 Multi Blood Glucose Test Strips are to be used with the MEG-2 Multi Blood Glucose Meter; it measures glucose in capillary whole blood taken from a fingertip, palm, or forearm. It is for use outside of body (in vitro diagnostic use). It indicated in a clinical setting to be used for multiple patients by healthcare professionals. This system is only used with single-use, auto-disabling lancing device. MEG-2 Glucose Control Solution The MEG-2 Glucose Control Solutions are used with the MEG-2 and MEG-2 Multi Blood Glucose Monitoring Systems to indicate appropriate user technique and to indicate {2} Page 3 of 15 that the test strip and meter are functioning properly. 3. Special conditions for use statement(s): - For Over the Counter use - Not intended for use on neonates - Not for the diagnosis of or screening for diabetes mellitus - Not to be used for patients who are dehydrated, hypotensive, in shock, critically ill or in a hyperosmolar state - Allows testing on the fingertip, palm, or forearm. - Alternative site testing can be used only during steady-state blood glucose conditions - Alternative site testing (AST) should not be used to calibrate continuous glucose monitors (CGMs) nor for use in insulin dose calculations. 4. Special instrument requirements: - The MEG-2 Blood Glucose Meter, The MEG-2 Multi Blood Glucose Meter - Disposable, single use lancing devices are used with the MEG-2 Multi Blood Glucose Meter I. Device Description: The MEG-2 Blood Glucose Monitoring System consists of the MEG-2 Blood Glucose Meter, MEG-2 Blood Glucose Test strips, and three levels of control solution (Low, Level 1, and Level 2). It is used for testing of blood glucose by self-testers at home. The MEG-2 Multi Blood Glucose Monitoring System consists of the MEG-2 Multi Blood Glucose Meter, MEG-2 Multi Blood Glucose Test strips, and three levels of control solution (Low, Level 1, and Level 2). It is used for testing of blood glucose by professional testers in healthcare facilities. The MEG-2 Blood and MEG-2 Multi Glucose Monitoring Systems are based on an electrochemical biosensor technology (electrochemical) and the principle of capillary action. Capillary action at the end of the test strip draws the blood into the action chamber and the blood glucose result is displayed in 6 seconds. The control solutions are used to test the performance of the device. The differences between the MEG-2 Blood Glucose Monitoring System and the MEG-2 Multi Monitoring Blood Glucose Monitoring System are labeling, which includes disinfection instructions for using the device in multiple patient use settings, and lancing devices. MEG-2 Multi Blood Glucose Monitoring System uses the single use, auto-disabling lancing device and the MEG-2 Blood Glucose Monitoring System uses the adjustable height lancing device. J. Substantial Equivalence Information: 1. Predicate device name(s): - GlucoSure STAR Blood Glucose Monitoring System 3 {3} Page 4 of 15 Contrex Plus Low Control Solution Contrex Plus Level 1 and Level 2 Control Solutions 2. Predicate 510(k) number(s): k073648, k100747, k062799 3. Comparison with predicate: | Item | Candidate Devices MEG-2 Blood Glucose Meter MEG-2 Multi Blood Glucose Meter | Predicate (k073648) GlucoSure STAR Blood Glucose Monitoring System | | --- | --- | --- | | Indications for use | The MEG-2 and MEG-2 Multi Blood Glucose Monitoring Systems are intended for the quantitative measurement of glucose in fresh capillary whole blood taken from fingertips, palm, or forearm. Testing is done outside the body (In Vitro Diagnostic use). The MEG-2 and MEG-2 Multi Blood Glucose Monitoring Systems are plasma-calibrated for easy comparison to lab results. The MEG-2 is indicated for lay use by people with diabetes as an aid to monitoring levels in Diabetes Mellitus and should only be used on a single patient. The MEG-2 Multi is indicated for a clinical setting to be used by multiple patients by healthcare professionals, as an aid to monitoring levels in Diabetes Mellitus. | Same | | Test Principle | Electrochemical biosensor with carbon electrodes that measures current produced by a chemical reaction | Same | | Enzyme | Glucose oxidase | Same | | Sample Type | Fresh capillary whole blood | Same | | Sample Site | Fingertip, the palm, the forearm | Same | | Memory feature | 300 measurement results with blood and control tests | Same | | Day average | 7-, 14-, 30- day average glucose result | Same | | Speaking function | No | Same | | Measuring time | 6 sec | Same | {4} Page 5 of 15 | Item | Candidate Devices MEG-2 Blood Glucose Meter MEG-2 Multi Blood Glucose Meter | Predicate (k073648) GlucoSure STAR Blood Glucose Monitoring System | | --- | --- | --- | | Measurement range | 20-600 mg/dL | Same | | Sample Volume | 1μL | Same | | Meter dimensions (mm) | 105(L)x53(W)x15(H) mm | 90(L)x53(W)x20(H) mm | | Weight (g) | 67 g | 80 g | | Test strip | MEG-2 Test Strip MEG -2 Multi Test Strip | GlucoSure STAR Test Strip | | Autocoding | Yes | No | | Item | Candidate Device MEG-2 Glucose Control Solutions | Predicate (k100747 – Contrex Plus Low Control Solution and k062799- Contrex Plus Level 1 and Level 2 Control Solutions) | | --- | --- | --- | | Indications for use | The MEG-2 Glucose Control Solutions are used with the MEG-2 and MEG-2 Multi Blood Glucose Monitoring Systems to indicate appropriate user technique and to indicate that the test strip and meter are functioning properly. | Same | | Test System | MEG-2 and MEG-2 Multi | GlucoSure STAR (Low) and GlucoTrack (Level 1 and 2) | | Analyte | D-glucose | Same | | Matrix | aqueous | Same | | Color | Red dye | Transparent | | Number of Levels and Target Ranges | 3 Levels Low: (34-64 mg/dL) Level 1: (88-120 mg/dL) Level 2: (176-238 mg/dL) | Same (total) Low: (40-70 mg/dL) Level 1: (87-131 mg/dL) Level 2: (186-280 mg/dL) | | Stability | Unopened (Shelf): 21 months at 15-30°C Opened: 3 months (90 days) at 15-30°C | Unopened (Shelf): 24 months at 15-30°C Opened: 3 months (90 days) at 15-30°C | 5 {5} Page 6 of 15 K. Standard/ Guidance Document Referenced (if applicable): - ISO15197:2003- 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 - EN 55011 ISM RF Equipment. Electromagnetic disturbance characteristics. Limits and methods of measurement - IEC/EN 60601-1: Medical electrical equipment Part 1. General requirements for safety, 2001. - IEC 61010-2: Safety particular requirements for IVD medical equipment, 2002. - 61000-3-2 EMC – Part 3-2: Limits – Limits for harmonic current emissions (equipment input current ≤ 16 A per phase). - 61000-3-3 EMC-Part 3-3: Limits-Limitation, v flucts/flicker public low-v supp systs equip w rated current ≤ 16A per phase - 61326-1 Electrical equipment for measurement, control and laboratory use – EMC requirements – part 1: General requirements - 61326-2-6 Electrical equipment for measurement, control, and laboratory use – EMC requirements – Part 2-6: Particular requirements – IVD medical equipment - 61010-1 Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1: General requirements - 61010-2-101 Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 2-101: Particular requirements – IVD medical equipment L. Test Principle: The test is based on electrochemical biosensor technology and the principle of capillary action. The electrical current generated by the reaction of glucose with the reagent of the strip is measured by the meter and is displayed as the corresponding blood glucose level. 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: The MEG-2 and the MEG-2 Multi are the same meters use the same test strips, however, they have separate names because of the different indications for use. a. Precision/Reproducibility: Within-run and between-run precision studies were performed. For the within-run precision studies, 10 replicates of each of 5 spiked venous whole blood glucose 6 {6} levels, were analyzed using 10 meters, and 3 lots of test strips. These tests were performed every day for 20 days. Results are summarized below. | | Test Strip Lot 1 | | | | --- | --- | --- | --- | | Samples | Mean | SD | % CV | | Interval 1 30-50 mg/dL | 42 | 2.97 | -- | | Interval 2 51-100 mg/dL | 80 | 2.94 | 3.7 | | Interval 3 111-150 mg/dL | 129 | 3.40 | 2.6 | | Interval 4 151-250 mg/dL | 202 | 4.83 | 2.4 | | Interval 5 251-400 mg/dL | 320 | 6.10 | 1.9 | | | Test Strip Lot 2 | | | | --- | --- | --- | --- | | Samples | Mean | SD | % CV | | Interval 1 30-50 mg/dL | 42 | 3.30 | -- | | Interval 2 51-100 mg/dL | 80 | 2.59 | 3.1 | | Interval 3 111-150 mg/dL | 129 | 3.71 | 2.9 | | Interval 4 151-250 mg/dL | 201 | 4.70 | 2.4 | | Interval 5 251-400 mg/dL | 320 | 5.93 | 1.9 | | | Test Strip Lot 3 | | | | --- | --- | --- | --- | | Samples | Mean | SD | % CV | | Interval 1 30-50 mg/dL | 42 | 2.78 | -- | | Interval 2 51-100 mg/dL | 81 | 2.51 | 3.0 | | Interval 3 111-150 mg/dL | 129 | 3.67 | 2.8 | | Interval 4 151-250 mg/dL | 201 | 4.88 | 2.5 | | Interval 5 251-400 mg/dL | 320 | 6.49 | 2.0 | {7} Page 8 of 15 A between-run precision study consisting of 10 replicates per day, for 20 days using each of 5 spiked venous whole blood glucose levels and 3 glucose control solutions, Low, Level 1, and Level 2 was conducted. Each sample was tested using 10 meters and 3 lots of test strips. Results are summarized below. | | Test Strip Lot 1 | | | | --- | --- | --- | --- | | Samples | Mean | SD | % CV | | Interval 1 30-50 mg/dL | 42 | 1.29 | -- | | Interval 2 51-100 mg/dL | 80 | 1.46 | 1.8 | | Interval 3 111-150 mg/dL | 129 | 1.11 | 0.9 | | Interval 4 151-250 mg/dL | 202 | 2.03 | 1.0 | | Interval 5 251-400 mg/dL | 320 | 1.54 | 0.5 | | Control Low (50 mg/dL) | 49 | 0.57 | -- | | Control Level 1 (100 mg/dL) | 104 | 1.57 | 3.5 | | Control Level 2 (200 mg/dL) | 206 | 2.44 | 1.2 | | | Test Strip Lot 2 | | | | --- | --- | --- | --- | | Samples | Mean | SD | % CV | | Interval 1 30-50 mg/dL | 42 | 1.15 | -- | | Interval 2 51-100 mg/dL | 80 | 1.65 | 2.0 | | Interval 3 111-150 mg/dL | 129 | 1.21 | 0.9 | | Interval 4 151-250 mg/dL | 201 | 2.39 | 1.2 | | Interval 5 251-400 mg/dL | 320 | 1.48 | 0.5 | | Control Low | 50 | 0.81 | -- | 8 {8} Page 9 of 15 | (50 mg/dL) | | | | | --- | --- | --- | --- | | Control Level 1 (100 mg/dL) | 104 | 1.42 | 3.5 | | Control Level 2 (200 mg/dL) | 207 | 1.92 | 0.9 | | | Test Strip Lot 3 | | | | --- | --- | --- | --- | | Samples | Mean | SD | % CV | | Interval 1 30-50 mg/dL | 42 | 1.28 | -- | | Interval 2 51-100 mg/dL | 81 | 1.43 | 1.8 | | Interval 3 111-150 mg/dL | 129 | 1.10 | 0.9 | | Interval 4 151-250 mg/dL | 201 | 2.03 | 1.0 | | Interval 5 251-400 mg/dL | 320 | 1.69 | 0.5 | | Control Low (50 mg/dL) | 50 | 0.74 | -- | | Control Level 1 (100 mg/dL) | 103 | 1.75 | 3.5 | | Control Level 2 (200 mg/dL) | 207 | 2.17 | 1.0 | b. Linearity/assay reportable range: Linearity was evaluated using 3 lots of test strips, 10 MEG-2 blood glucose meters, and 8 venous whole blood samples with glucose levels ranging from 15-610 mg/dL, obtained by spiking pooled venous blood with a glucose solution. Each glucose level was analyzed 40 times over 3 test strip lots. Linear regression analysis for each test strip lot compared to the YSI resulted in: $$ y = 0.9948x + 0.0568; R^2 = 0.9988 \text{ for Test Strip Lot 1} $$ $$ y = 0.9879x + 1.0573; R^2 = 0.9986 \text{ for Test Strip Lot 2} $$ $$ y = 0.9976x + 0.3156; R^2 = 0.9989 \text{ for Test Strip Lot 3} $$ The claimed range of measurement for this device is 20 to 600 mg/dL. 9 {9} Page 10 of 15 c. Traceability, Stability, Expected values (controls, calibrators, or methods): Three levels of control material, MEG-2 Glucose Control Solution Low (34-64 mg/dL), MEG-2 Control Solution Level 1 (88-120 mg/dL) and MEG-2 Control Solution Level 2 (176-238 mg/dL), are available for use with this test system. The glucose standard set NERL 1343 was used to trace the analyte of the control solutions. The NERL 1343 standard is traceable to the NIST glucose standard. All three levels are provided with the meters of this submission. Shelf life and open vial stability were evaluated through real-time studies at 30°C and 80% humidity using 3 lots of each control solution. The results support a 21 month shelf life and the 90 day open vial stability claims. Real-time stability studies for shelf-life of the control solutions are ongoing. The recommended storage temperature for control solutions is 15 to 30°C and below 80% humidity. The recommended storage temperature for the test strips is 39 to 86°F (6 months). d. Detection limit: The reportable range is 20 to 600 mg/dL based on linearity/reportable range studies above (section M.1.b.). e. Analytical specificity: The sponsor tested substances for interference using 1 lot of test strips (10 test strips per interferent level), 10 meters, and 3 levels of glucose (achieved by adjusting human venous blood glucose levels to the ranges of 50-70, 110-130, and 300-330 mg/dL). Samples were then spiked with the following interfering substances. Each sample was analyzed 10 times. The labeling states that elevated concentration of L-DOPA (&gt;1.5 mg/dL), ibuprofen (&gt;40 mg/dL), tolazamide (&gt;60 mg/dL), ascorbic acid (&gt;5.0 mg/dL), fructose (&gt;15 mg/dL), uric acid (&gt;15 mg/dL), cholesterol (&gt;400 mg/dL), bilirubin conjugated (&gt;15 mg/dL), bilirubin unconjugated (&gt;25 mg/dL), and triglyceride (&gt;2000 mg/dL), and methyl-dopa (&gt;7.5 mg/dL) may affect test results. The following table lists the concentrations of each substance at which no significant interference (≤10%) was detected: | Interfering Substance | Therapeutic/ Physiological Levels (mg/dL) | Test Levels (mg/dL) | | --- | --- | --- | | Acetaminophen | 1 – 3 | 10 and 20 | | Tolbutamide | 5.4 – 10.8 | 10 and 64 | | Dopamine | 0.03 | 0.05 and 0.1 | | Salicylic acid | 10 – 30 | 40 and 65 | | Methyl-Dopa | 1 – 7.5 | 7.5 and 15.0 | | Tetracycline | 0.2 – 0.5 | 0.5 and 1.5 | {10} Page 11 of 15 | Ephedrine | 0.014 | 0.02 and 0.05 | | --- | --- | --- | | Mannitol | 10 | 15 and 30 | | Mannose | 1.2 | 2.0 and 4.0 | | Sorbitol | 0.05 | 0.1 and 0.2 | | Maltose | -- | 20 and 50 | | EDTA | -- | 1x and 5x | | Lactose | -- | 10 and 25 | | Heparin | -- | 1x and 5x | | Maltotriose | -- | 120 and 240 | | Maltotetraose | -- | 60 and 120 | | Xylitol | 0.02 | 0.05 and 0.1 | | Xylose | -- | 10 and 20 | | Hemoglobin | 100 - 200 | 100 and 200 | | Creatinine | 0.6 – 1.3 | 2.0 and 5.0 | | Galactose | < 5 | 10 and 15 | f. Assay cut-off: Not Applicable. 2. Comparison studies: a. Method comparison with predicate device: Reference Method Comparison: The sponsor performed a system accuracy evaluation comparing the MEG-2 to YSI. Healthcare professionals tested 111 capillary samples in 6 concentration categories (55-80, 81-120, 121-200, 201-300, 301-400, and $&gt;400$ mg/dL) per strip, using 8 meters and 3 lots of test strips using the MEG-2 meter and the YSI (the reference method). Eight additional glycolyzed samples were also tested to obtain concentrations $&lt; 55$ mg/dL and one sample was spiked to obtain an additional concentration $&gt;400$ mg/dL. Results are summarized below. For glucose concentrations $&lt; 75\mathrm{mg / dL}$ | within ± 5 mg/dL | within ± 10 mg/dL | within ± 15 mg/dL | | --- | --- | --- | | 16/22 (73%) | 21/22 (96%) | 22/22 (100.0%) | For glucose concentrations $\geq 75\mathrm{mg / dL}$ | within ± 5 % | Within ± 10 % | within ± 15 % | within ± 20 % | | --- | --- | --- | --- | | 65/98 | 95/98 | 98/98 | 98/98 | | (66%) | (97%) | (100.0%) | (100.0%) | Linear Regression Analysis: | Comparison | N | Slope and y-intercept | R2 | | --- | --- | --- | --- | | MEG-2 vs. YSI | 120 | Y = 1.0246x -3.027 | 0.992 | {11} Page 12 of 15 b. Matrix comparison: Not applicable. Capillary whole blood is the only indicated matrix. 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): Fingerstick and Alternative Site Testing Comparison Studies: The sponsor performed a lay-user study where accuracy of the device was tested using 111 fingerstick samples obtained by the lay-user and 111 samples per each alternative site (the palm and the forearm) obtained by the lay-user. Participants, who were able to read the User's Manual in English, were instructed to read the manual and perform testing on the finger and then the alternative sites. A technician collected capillary blood for measurements on YSI. Results were obtained for each of the alternative sites. Samples ranged from 55 to $474\mathrm{mg / dL}$ . Results are summarized below. For glucose concentrations $&lt; 75\mathrm{mg / dL}$ | Sites | within ± 5 mg/dL | within ± 10 mg/dL | within ± 15 mg/dL | | --- | --- | --- | --- | | Finger | 6/14 (43%) | 13/14 (93%) | 14/14 (100.0%) | | Palm | 4/14 (29%) | 9/14 (64%) | 14/14 (100.0%) | | Forearm | 2/14 (14%) | 10/14 (71%) | 14/14 (100.0%) | For glucose concentrations $\geq 75\mathrm{mg / dL}$ | Site | Within ± 5 % | within ± 10 % | within ± 15 % | within ± 20 % | | --- | --- | --- | --- | --- | | Finger | 55/97 (57%) | 86/97 (89%) | 96/97 (99%) | 97/97 (100.0%) | | Palm | 51/97 (51.2%) | 84/97 (87%) | 96/97 (99%) | 97/97 (100.0%) | | Forearm | 45/97 (46%) | 84/97 (87%) | 96/97 (99%) | 97/97 (100.0%) | Linear Regression Analysis: | Comparison | N | Slope and y-intercept | R2 | | --- | --- | --- | --- | | Finger vs. YSI | 111 | Y = 1.0143x -4.4601 | 0.987 | | Palm vs. YSI | 111 | Y = 0.9947x- 4.3049 | 0.985 | | Forearm vs. YSI | 111 | Y = 0.9945x -1.9052 | 0.983 | {12} Page 13 of 15 4. Clinical cut-off: Not Applicable. 5. Expected values/Reference range: | Time of day | Range, Non-diabetes | | --- | --- | | Before meals | Less than 100 mg/dL | | After meals | Less than 140 mg/dL | The sponsor references: American Diabetes Association. Standards of Medical Care in Diabetes, Diabetes Care. 2010;33:S11-S61. N. Instrument Name: The MEG-2 Blood Glucose Meter and the MEG-2 Multi Blood Glucose Meter O. System Description: 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 ☐ The applicant has provided documentation that indicates the device was designed and developed under good software life-cycle processes. 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: 13 {13} Page 14 of 15 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: The meter is a non-coding meter, therefore no coding is required by the user. 6. Quality Control: The sponsor manufactures three levels of glucose control solution, Low, Level 1, and Level 2 to be used with the MEG-2 glucose monitoring systems. These control solutions must be purchased separately and are not provided with the device kits. Instructions for how to purchase the control solution are provided in the user manuals. To perform a control test the user is instructed to press the down or up buttons while the blood drop symbol is flashing. The "ctl" symbol will then appear on the display. 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 problems and more information P. Other Supportive Instrument Performance Characteristics Data Not Covered In the "Performance Characteristics" Section above: 1. The device is intended for single-patient (MEG-2) or healthcare professional use (MEG-2 Multi). Disinfection studies were performed on the MEG-2 meter and lancet device by outside commercial laboratory testing services to determine the disinfection efficacy of the meter and lancing device to the recommended cleaning and disinfection protocol, and its effectiveness in preventing the spread of bloodborne pathogens, particularly hepatitis B virus (HBV). Dispatch Hospital Cleaner Disinfectant Towels with Bleach disposable wipes (EPA Reg. No: 56392-8) were validated, demonstrating complete inactivation of live virus for use with the meter and lancing device. The sponsor also conducted robustness studies and demonstrated that there was no change in performance or in the external materials of the meter and lancing device after 1,825 cleaning and disinfection cycles to simulate 5 years of use by lay-users and after 10,950 cleaning and disinfection cycles to simulate 3 years of use by healthcare professionals. Each robustness cycle tested consisted of one pre-clean wipe and one disinfecting wipe. 2. The effect of different hematocrit levels was evaluated with 3 lots of test strips using 10 test strips at each of 5 concentration ranges of glucose (30-50, 51-120, 121-170, 250-350, 451-550 mg/dL). The glucose samples were prepared from venous blood samples at 5 hematocrit levels at approximately 30, 35, 43, 50 and 55%. In total 750 measurements were made and each of the results compared to the value obtained from the same plasma glucose concentration obtained by YSI. The % individual bias did not exceed ± 15% for all glucose concentrations within the hematocrit claimed range of 30 to 55%. 3. The effect of altitude was evaluated at five whole blood samples with glucose concentrations ranging from 50 to 600 mg/dL, testing at sea level and 3150 meters 14 {14} Page 15 of 15 (10,334 feet above sea level). Each glucose concentration was measured 20 times at each altitude. The bias was calculated relative to YSI at sea level and at 3150 meters. The results demonstrate that the system meets the acceptance criteria for testing at altitudes up to 3,150 meters (10,334 feet above sea level) with biases less than ± 10% to YSI for all glucose concentrations. 4. The sponsor performed temperature and humidity studies at the combined extremes of 10°C/RH: 22%, 40°C/RH: 22%, 10°C/RH: 90%, and 40°C/RH: 90%, with venous blood samples (50-400 mg/dL) that demonstrated that the MEG-2 and MEG-2 Multi meters can be used at temperatures of 50 to 104°F (10 to 40°C) and 22% to 90% relative humidity. 5. The sponsor provided a readability study and obtained Flesch-Kincaid Grade Level Scores of 8.1, 8.2, and 8.1 for the MEG-2 test strip insert, MEG-2 Multi test strip insert, and the control solutions insert, respectively. Flesch-Kincaid Grade Level Scores of 7.2 and 7.5 were obtained for the MEG-2 User's Manual and MEG-2 Multi User's Manual, respectively. 6. The sponsor stated that they conformed to the following guidelines and provided the appropriate documentation to demonstrate compliance: - IEC/EN 60601-1-2: Medical electrical equipment, Part 2. Electromagnetic compatibility, 2007. - EN 61000-3-2: Medical electrical equipment Part 2. Electromagnetic compatibility, 2006. - EN 61000-3-3: Medical electrical equipment Part 3. Electromagnetic compatibility, 2008. - EMC testing was evaluated and certified by QuieTek of Taiwan (R.O.C.) and a letter of attestation was issued to Apex Biotechnology Corp. on March 30, 2010. Q. Proposed Labeling: The labeling is sufficient and does satisfy 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. 15