BGM009 BLOOD GLUCOSE MONITORING SYSTEM

{0} 1 # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k141036 B. Purpose for Submission: New Device C. Measurand: Capillary whole blood glucose D. Type of Test: Quantitative Amperometric assay (Glucose oxidase) E. Applicant: Apex Technology Corporation F. Proprietary and Established Names: BGM009 Blood Glucose Monitoring System G. Regulatory Information: 1. Regulation section: 21 CFR 862.1345, Glucose test system 2. Classification: Class II 3. Product code: NBW, System, Test, Blood Glucose, Over The Counter CGA, Glucose Oxidase, Glucose 4. Panel: Clinical Chemistry (75) {1} H. Intended Use: 1. Intended use(s): See indications for use below. 2. Indication(s) for use: The BGM009 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). The device includes speaking functions but is not intended for use in visually impaired users. It is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitoring the effectiveness of diabetes control 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 BGM009 Blood Glucose Test Strips are to be used with the BGM009 Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. 3. Special conditions for use statement(s): - Inaccurate results may occur in severely hypotensive individuals, patients in shock. - Inaccurate low results may occur for individuals experiencing a hyperglycemic-hyperosmolar state (with or without ketosis). - Incorrect results may occur in individuals who are dehydrated. - Critically ill patients should not be tested with this device. - Not for use in neonates. - Not for screening or diagnosis of diabetes. - The meter and lancing device are for single patient use - Alternative site testing (AST) testing should only be done during steady-state times (when glucose is not changing rapidly). - AST site measurements should never be used to calibrate continuous glucose monitors (CGMs). - AST site measurements should never be used for insulin dose calculations. - Altitudes above 10,335 feet have not been evaluated. 4. Special instrument requirements: BGM009 Blood Glucose Meter {2} 3 I. Device Description: The BGM009 Blood Glucose Monitoring System consists of the BGM009 Blood Glucose Meter, BGM009 Blood Glucose Test Strips (sold separately), three levels of Contrex Plus 4 control solutions (Level 1, Level 2, and Level 3; previously cleared under k131750; sold separately), log book, carrying case and user manual. The system includes auto-calibration codes and an under-fill detection feature. The system also includes a hematocrit compensation feature, a voice function, ability to store blood test results with a date and time stamp, and averaging over 7, 14, or 30 days. J. Substantial Equivalence Information: 1. Predicate device name(s): AutoSure Voice II Plus Blood Glucose Monitoring System. 2. Predicate K number(s): k113098 3. Comparison with predicate: | Similarities and Differences of the Blood Glucose System | | | | --- | --- | --- | | Item | Predicate Device AutoSure Voice II Plus (k113098) | New Device | | Intended Use/Indications for Use | Intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm as an aid to monitor the effectiveness of diabetes control. | Same | | Detection method | Amperometry | Same | | Enzyme | Glucose Oxidase | Same | | Memory | 300 test results including blood and control test | Same | | Test range | 20 - 600 mg/dL | Same | | Hematocrit range | 30 - 55% | 20-60% | {3} | Hematocrit compensation feature | No | Yes | | --- | --- | --- | | Minimum sample volume | 0.8 μL | 0.5 μL | | Sample test time | 6 seconds | Same | # K. Standard/Guidance Document Referenced (if applicable): 1. CLSI - EP6-A: Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline 2. IEC - 60601 - 1-2; 2001, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility-Requirements and Tests 3. IEC - 61000-3-2; 2005, Electromagnetic compatibility (EMC) - Part 3-2: Limits - Limits for harmonic current emissions (equipment input current $\leq 16\mathrm{A}$ per phase) 4. IEC - 61000-3-3; 2005, Electrical equipment for measurement, control and laboratory use-EMC requirements - Part 1: General requirements 5. IEC - 61326 - 1; 2005, Electrical equipment for measurement, control and laboratory use-EMC requirements - Part 1: General requirements 6. IEC - 61326 - 2-6; 2005, Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment 7. IEC - 61010 - 1; 2010, Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements 8. IEC/EN - 61010-2-101; 2009, Safety requirements for electrical equipment for measurement, control and laboratory use- Part2 - 101: Particular requirements for in vitro diagnostic (IVD) medical equipment 9. IEC - 60601-1; 1995, Medical Electrical Equipment - Part 1: General Requirements for Safety 10. CEN/EN 55011; 2007, Industrial, scientific and medical (ISM) radio-frequency Equipment, Electromagnetic disturbance characteristics. Limits and methods of measurement # L. Test Principle: The BGM009 Blood Glucose meters and test strips use biosensor technology. The test strips contain an enzyme, glucose oxidase (Aspergillus niger) that 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 these measurements into blood glucose readings that are displayed on the meter's liquid crystal display. The system is plasma-calibrated. {4} M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: The sponsor performed within-run precision studies using venous whole blood samples spiked to achieve five glucose concentrations (40, 100, 150, 220, 330 mg/dL). Each glucose level was analyzed in replicates of 10 using 10 BGM009 meters and three lots of test strips for a total of 200 tests per glucose level per test strip lot for a total of 600 test per glucose level. Results are summarized below: Within-run precision: | | Glucose Level (mg/dL) | Mean (mg/dL) | SD (mg/dL) | CV (%) | | --- | --- | --- | --- | --- | | Test Strip Lot 1 | | | | | | | 30 to 50 | 40 | 2.4 | 5.9 | | | 51 to 110 | 100 | 3.3 | 3.3 | | | 111 to 150 | 150 | 3.9 | 2.6 | | | 151 to 250 | 219 | 5.6 | 2.6 | | | 251 to 400 | 334 | 8.4 | 2.5 | | Test Strip Lot 2 | | | | | | | 30 to 50 | 41 | 3.5 | 6.2 | | | 51 to 110 | 100 | 3.1 | 3.1 | | | 111 to 150 | 148 | 3.8 | 2.6 | | | 151 to 250 | 221 | 6.4 | 2.9 | | | 251 to 400 | 330 | 7.3 | 2.2 | | Test Strip Lot 3 | | | | | | | 30 to 50 | 40 | 2.4 | 6.0 | | | 51 to 110 | 102 | 2.9 | 2.9 | | | 111 to 150 | 148 | 4.3 | 2.9 | | | 151 to 250 | 220 | 4.8 | 2.2 | | | 251 to 400 | 331 | 7.4 | 2.2 | | Combined | | | | | | | 30 to 50 | 40 | 2.4 | 5.8 | | | 51 to 110 | 101 | 3.0 | 3.0 | | | 111 to 150 | 148 | 3.9 | 2.6 | | | 151 to 250 | 220 | 5.4 | 2.5 | | | 251 to 400 | 332 | 7.4 | 2.2 | Between-run precision was evaluated using three Contrex Plus 4 control solution levels: 55, 100, and 220 mg/dL. Between-Run precision was calculated from {5} control solutions analyzed once per day on 10 meters using 3 lots of test strips over 20 days and was determined for each lot tested, for a total of 600 test per glucose level. Results are summarized below: | Test Strip Lot | Glucose Level | Mean (mg/dL) | SD (mg/dL) | CV (%) | | --- | --- | --- | --- | --- | | 1 | 55 | 55 | 0.7 | 1.4 | | | 100 | 112 | 1.6 | 1.4 | | | 220 | 220 | 1.7 | 0.8 | | 2 | 55 | 57 | 0.6 | 1.0 | | | 100 | 110 | 0.8 | 0.7 | | | 220 | 218 | 1.3 | 0.6 | | 3 | 55 | 58 | 0.8 | 1.4 | | | 100 | 113 | 1.1 | 1.0 | | | 220 | 221 | 1.2 | 0.6 | b. Linearity/assay reportable range: Linearity was evaluated using venous whole blood supplemented with glucose, or allowed to undergo glycolysis, to achieve 11 glucose concentrations ranging from 20 to 640 mg/dL (18, 30, 43, 62, 102, 130, 204, 340, 422, 549, and 640 mg/dL as measured by YSI). Each glucose level was measured on the BGM009 meter in replicates using 3 test strip lots and the values compared with those obtained on the YSI. Results from regression analysis: | Lot # | Slope | y-intercept | r value | | --- | --- | --- | --- | | 1 | 1.0209 | -2.9631 | 0.9989 | | 2 | 1.0125 | 1.0230 | 0.9984 | | 3 | 0.9923 | 2.1349 | 0.9988 | The results of the study support the sponsor's claimed glucose measurement range of 20-600 mg/dL. Testing was performed to validate acceptable performance of the "LO" (&lt; 20 mg/dL glucose) and high "HI" (&gt; 600 mg/dL glucose) alert features of the system. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability: The BGM009 Blood Glucose Monitoring System is traceable to the NIST SRM 917c reference material. The method comparison study was performed using the candidate device and YSI as the reference method (see Section 2.a.). {6} 7 # Test Strip Stability: The Sponsor's protocols and acceptance criteria for real-time testing of closed and opened test strip vial stability were reviewed and found to be acceptable to support the labeled claims of a 6-month shelf life and 6-month open vial use-life at the recommended storage conditions of 39-86°F and a relative humidity of 10-85%. **Control Solutions:** Value assignment and closed and opened vial stability protocols and acceptance criteria were previously reviewed (k131750) and found to be acceptable for the Contrex Plus 4 control solutions Level 1, Level 2, and Level 3. The manufacture claims a 24 month shelf life and 3 month open vial stability when stored at the recommended storage temperatures of 39°F to 86°F. ## d. Detection limit: See linearity study in Section M1b above. ## e. Analytical specificity: Potential interfering substances were tested by spiking venous whole blood samples to achieve two levels of glucose (70-90 mg/dL and 300-330 mg/dL). Each potential interferent was added to each of the glucose containing solutions at a minimum of two levels. Each test sample was measured in replicates of 10 with 10 BGM009 meters and results compared to those obtained on the reference method (YSI). The % bias between the meter result and the YSI result was calculated and the sponsor defines no significant interference as ≤ 10% difference in these results. The highest concentrations with no significant observed interference are listed in the table below: | Potential Interfering Substance | Highest concentration tested with no significant interference (mg/dL) | | Potential Interfering Substance | Highest concentration tested with no significant interference (mg/dL) | | --- | --- | --- | --- | --- | | Acetaminophen | 10 | | L-Dopa | 3.0 | | Acetylsalicylic Acid | 40 | | Maltose | 50 | | Ascorbic Acid | 6.0 | | Mannitol | 30 | | Bilirubin – unconjugated | 20 | | Mannose | 4 | | Bilirubin – conjugated | 30 | | Maltoteraose | 120 | {7} | Cholesterol | 500 | | Maltotriose | 240 | | --- | --- | --- | --- | --- | | Creatinine | 5 | | Methyl-Dopa | 15 | | Dopamine | 0.1 | | Paralidoxime Iodide | 50 | | Ephedrine | 0.05 | | Sorbitol | 0.2 | | Fructose | 20 | | Tolbutamide | 15 | | Galactose | 15 | | Tetracycline | 1.5 | | Gentisic Acid | 2 | | Tolazamide | 23 | | Glutathione | 46 | | Triglyceride | 1500 | | Hemoglobin | 200 | | Uric Acid | 15 | | Ibuprofen | 40 | | Xylitol | 0.1 | | Icodextrin | 1094 | | Xylose | 25 mg/dL | | Lactose | 25 | | | | The sponsor has the following limitations in their labeling: - Acetaminophen levels above 10 mg/dL may give falsely low test results Tolbutamide levels above 15 mg/dL may cause falsely low test results Ibuprofen levels above 40 mg/dL may cause falsely low test results Acetylsalicylic acid levels above 40 mg/dL may give falsely low test results - Tolazamide levels above 23 mg/dL may cause falsely high test results. - Paralidoxime Iodide (PAM) levels above 50 mg/dL may cause falsely high test results. - Uric acid levels above 15 mg/dL may give falsely low test results. - Cholesterol levels above 500 mg/dL may give falsely low test results - Triglyceride levels above 1500 mg/dL may give falsely high test results - Glutathione levels above 46 mg/dL may give falsely high test results. - Do not use during a xylose absorption test. This may cause inaccurately high results. f. Assay cut-off: Not applicable. 2. Comparison studies: a. Method comparison with predicate device: A study by professional users was performed on samples from fingerstick, forearm, and palm. One hundred and forty three (patient) participants were included for each anatomical sample type. In addition, 8 fingerstick samples were allowed to glycolyze to achieve low glucose concentrations &lt; 50 mg/dL (for a total of 151 fingerstick samples). Three strip lots were tested; a different sample set was run on each test strip lot. Results from the BGM009 meter were compared to those of the comparator method, YSI 2300. The glucose concentration range tested included 36-473 mg/dL as measured on {8} YSI. The results relative to YSI are summarized below: # Fingertip Samples: Glucose concentrations $&lt; 75\mathrm{mg / dL}$ | Test Strip Lot | Within ± 5mg/dL | Within ± 10 mg/dL | Within ± 15 mg/dL | Within ± 20 mg/dL | | --- | --- | --- | --- | --- | | 1 | 9/11 (82%) | 11/11 (100%) | 11/11 (100%) | 11/11 (100%) | | 2 | 8/8 (88%) | 8/8 (100%) | 8/8 (100%) | 8/8 (100%) | | 3 | 5/5 (100%) | 5/5 (100%) | 5/5 (100%) | 5/5 (100%) | | Combined | 22/24 (92%) | 24/24 (100%) | 24/24 (100%) | 24/24 (100%) | Glucose concentrations $\geq 75\mathrm{mg / dL}$ | Test Strip Lot | Within ± 5% | Within ± 10% | Within ± 15% | Within ± 20% | | --- | --- | --- | --- | --- | | 1 | 28/40 (70%) | 40/40 (100%) | 40/40 (100%) | 40/40 (100%) | | 2 | 31/42 (74%) | 40/42 (95%) | 42/42 (100%) | 42/42 (100%) | | 3 | 21/45 (47%) | 37/45 (82%) | 45/45 (100%) | 45/45 (100%) | | Combined | 80/127 (64%) | 117/127 (92%) | 127/127 (100%) | 127/127 (100%) | # Palm Samples: Glucose concentrations $&lt; 75\mathrm{mg / dL}$ | Test Strip Lot | Within ± 5 mg/dL | Within ± 10 mg/dL | Within ±15 mg/dL | Within ±20 mg/dL | | --- | --- | --- | --- | --- | | 1 | 7/8 (88%) | 8/8 (100%) | 8/8 (100%) | 8/8 (100%) | | 2 | 4/5 (80%) | 5/5 (100%) | 5/5 (100%) | 5/5 (100%) | | 3 | 1/3 (33%) | 3/3 (100%) | 3/3 (100%) | 3/3 (100%) | | Combined | 12/16 (75%) | 16/16 (100%) | 16/16 (100%) | 16/16 (100%) | Glucose concentrations $\geq 75\mathrm{mg / dL}$ | Test Strip Lot | Within ± 5% | Within ± 10% | Within ± 15% | Within ± 20% | | --- | --- | --- | --- | --- | | 1 | 27/40 (68%) | 37/40 (93%) | 40/40 (100%) | 40/40 (100%) | | 2 | 32/42 (76%) | 38/42 (90%) | 42/42 (100%) | 42/42 (100%) | | 3 | 25/45 (56%) | 41/45 (91%) | 45/45 (100%) | 45/45 (100%) | | Combined | 84/127 (66%) | 116/127 (91%) | 127/127 (100%) | 127/127 (100%) | {9} # Forearm samples: Glucose concentrations $&lt; 75\mathrm{mg / dL}$ | Test Strip Lot | Within ± 5mg/dL | Within ± 10 mg/dL | Within ± 15 mg/dL | Within ± 20 mg/dL | | --- | --- | --- | --- | --- | | 1 | 7/8 (88%) | 8/8 (100%) | 8/8 (100%) | 8/8 (100%) | | 2 | 4/5 (80%) | 5/5 (100%) | 5/5 (100%) | 5/5 (100%) | | 3 | 3/3 (100%) | 3/3 (100%) | 3/3 (100%) | 3/3 (100%) | | Combined | 15/16(94%) | 16/16 (100%) | 16/16 (100%) | 16/16 (100%) | Glucose concentrations $\geq 75\mathrm{mg / dL}$ | Test Strip Lot | Within ± 5% | Within ± 10% | Within ± 15% | Within ± 20% | | --- | --- | --- | --- | --- | | 1 | 24/40 (60%) | 37/40 (93%) | 40/40 (100%) | 40/40 (100%) | | 2 | 32/42 (76%) | 40/42 (95%) | 41/42 (98%) | 42/42 (100%) | | 3 | 27/45 (60%) | 40/45 (89%) | 45/45 (100%) | 45/45 (100%) | | Combined | 83/127 (65%) | 117/127 (92%) | 126/127 (99%) | 127/127 (100%) | Regression analysis results: | | Test strip lot | Range of glucose values | Slope and y-intercept | R2 | | --- | --- | --- | --- | --- | | Fingertip | 1 | 40-383 | y=1.0016x+0.404 | 0.9924 | | | 2 | 36-473 | y=1.0031x-1.205 | 0.9939 | | | 3 | 41-396 | y=1.016x-4.032 | 0.9869 | | | Combined | 36-473 | y=1.006x-1.494 | 0.9918 | | Palm | 1 | 65-383 | y=1.010x-2.927 | 0.9909 | | | 2 | 65-473 | y=1.000x-2.319 | 0.9930 | | | 3 | 70-396 | y=1.019x-4.452 | 0.9862 | | | Combined | 65-473 | y=1.007x-2.878 | 0.9908 | | Forearm | 1 | 65-383 | y=0.993x-0.974 | 0.9886 | | | 2 | 65-473 | y=0.989x-1.407 | 0.9938 | | | 3 | 70-396 | y=1.031x-4.694 | 0.9894 | | | Combined | 65-473 | y=0.998x-1.459 | 0.9906 | # b. Matrix comparison: Not applicable # 3. Clinical studies: {10} a. Clinical Sensitivity: Not applicable b. Clinical specificity: Not applicable c. Other clinical supportive data (when a. and b. are not applicable): To assess system accuracy in the hands of the intended users, results from the BGM009 Blood Glucose Monitoring System by lay users were compared to a reference method, YSI 2300. Capillary samples from 143 participants with glucose concentrations ranging from 65 to $473\mathrm{mg / dL}$ were tested using three test strip lots. Lay user participants tested fingerstick, as well as the palm and forearm (alternative sites) using instructions in the device manual. Results are summarized in the tables below: For glucose concentrations $&lt; 75\mathrm{mg / dL}$ | Site | within ± 5 mg/dL | within ± 10 mg/dL | within ± 15 mg/dL | Within ± 20 mg/dL | | --- | --- | --- | --- | --- | | Finger | 12/16 (75%) | 16/16 (100%) | 16/16 (100%) | 16/16 (100%) | | Palm | 15/16 (94%) | 16/16 (100%) | 16/16 (100%) | 16/16 (100%) | | Forearm | 13/16 (81%) | 16/16 (100%) | 16/16 (100%) | 16/16 (100%) | For glucose concentrations $\geq 75\mathrm{mg / dL}$ | Site | within ± 5 % | within ± 10 % | within ± 15 % | within ± 20 % | | --- | --- | --- | --- | --- | | Finger | 67/127 (53%) | 115/127 (91%) | 125/127 (98%) | 127/127 (100%) | | Palm | 68/127 (54%) | 119/127 (94%) | 127/127 (100%) | 127/127 (100%) | | Forearm | 64/127 (50%) | 109/127 (86%) | 125/127 (98%) | 127/127 (100%) | {11} Regression analysis results: | | Test Strip Lot | Range of glucose values | Slope and y-intercept | R2 | | --- | --- | --- | --- | --- | | Fingertip | 1 | 65-383 | y=0.9876x-1.720 | 0.992 | | | 2 | 65-473 | y=0.998x-2.180 | 0.992 | | | 3 | 70-396 | y=1.027x-5.794 | 0.983 | | | Combined | 65-473 | y=1.001x-2.754 | 0.989 | | Palm | 1 | 65-383 | y=0.997x-2.359 | 0.989 | | | 2 | 65-473 | y=1.002x-2.705 | 0.990 | | | 3 | 70-396 | y=1.024x-4.962 | 0.980 | | | Combined | 65-473 | y=1.004x-2.932 | 0.987 | | Forearm | 1 | 65-383 | y=0.987x-4.417 | 0.989 | | | 2 | 65-473 | y=0.994x-3.514 | 0.991 | | | 3 | 70-396 | y=1.023x-5.683 | 0.979 | | | Combined | 65-473 | y=0.997x-3.879 | 0.987 | Users also completed questionnaires, and were asked to rate the ease-of-understanding of each section on a 5-level scale ranging from very easy to very difficult. Scores of 5, 4, 3, 2, and 1 were assigned to each rating level, respectively, such that the most favorable rating possible was 5 (Very Easy). Users were also asked to evaluate the extent to which the illustrations in the User's Manual supported operating the meter easily and quickly, using the same rating scale. Responses to all five questions were reviewed and found to be acceptable. Flesch-Kincaid readability assessments were conducted on all labeling. Results demonstrated an $8^{\text{th}}$ grade or less readability for the User's Manual, test strip insert and control solutions package insert. # 4. Clinical cut-off: Not applicable # 5. Expected values/Reference range: The device package insert includes the following: The blood glucose value depends on many factors. The ideal ranges for adults {12} without diabetes are: | Fasting | <100 mg/dL | | --- | --- | | Two hours after meals | <140 mg/dL | Reference: American Diabetes Association, Clinical Practice Recommendations (2013) Diabetes Care, Vol. 36, Supplement 1, p S1–S100. ## N. Instrument Name: BGM009 Blood Glucose Meter ## O. System Descriptions: 1. Modes of Operation: Each test strip is single use and requires a sample volume of 0.5 µL. 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. 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, palm, and forearm only. The whole blood sample is applied directly to the test strip by capillary action. 5. Calibration: The BGM009 meter uses automatically-read built in calibration codes. There is no user input for coding. 13 {13} 14 6. Quality Control Contrex Plus 4 control solutions (Level 1, Level 2, and Level 3; previously cleared under k131750) are available with this system. The meter has a user initiated function (with a ‘ctl’ icon) to prevent control results from being used in the calculation of averages. The control solution results are stored in the meter memory and are indicated by a ‘ctl’ icon. Recommendations on when to test the control materials are provided in the labeling. An acceptable range for each control level is printed on the test strip vial label. The user is cautioned not to use the meter 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 effect of different hematocrit levels on the performance of the BGM009 Blood Glucose Monitoring System was evaluated using venous whole blood samples at five glucose levels of approximately 40, 60, 130, 300, 500 mg/dL. At each glucose level, samples were prepared with hematocrit levels of 20, 25, 30, 35, 40, 45, 50, 55, and 60% hematocrit. At each glucose/hematocrit level, 10 replicates were tested on each of 3 lots BGM009 test strips and the values were compared with those obtained from YSI-2300 analyzer. The results demonstrate acceptable performance of the BGM 009 Blood Glucose Monitoring System produces over the claimed hematocrit range of 20-60%. 2. Altitude study: Venous whole blood samples at five (5) glucose levels (approximately 50, 121, 219, 331, and 449 mg/dL) were tested at sea level and 10,335 feet (3150 meters) above sea level. Twenty readings per glucose level were taken at each of the 2 elevations including sea level and 10,335 ft. and results from the BGM009 Blood Glucose Monitoring System were compared to YSI. Results demonstrate acceptable bias to YSI to support the claims in the labeling that altitudes up to 10,335 feet have no significant effect on blood glucose measurements from the BGM 009 Blood Glucose Monitoring System. 3. Sample Volume: To determine the minimum sample volume, venous whole blood sample volumes of 0.3, 0.4, 0.5, 0.6, and 0.7 µL were tested. Sample concentrations included three glucose levels (40 mg/dL, 120 mg/dL, and 330 mg/dL). Testing included 10 test strips for each of three lots of test strips for each test volume and each glucose level. Study results adequately support the claimed minimal sample volume of 0.5 µL. 4. Temperature and humidity studies: Ten BGM009 meters, and 3 lots of BGM009 test strips were used to verify accurate performance within the temperature and humidity conditions claimed for the system. Venous whole blood at 60, 120, 200, and 400 mg/dL glucose were tested. Five temperature and humidity combinations were tested including low temperature/low {14} humidity, low temperature/high humidity, average temperature/average humidity, high temperature/low humidity, and high temperature/high humidity. Results support the operating conditions claim of 50-104°F (10-40°C) and 20-90% RH. 5. Infection Control Studies: The device is intended for single-patient use only. Disinfection efficacy studies for the external meter materials were reviewed under k131750 and demonstrated that complete inactivation of live virus (hepatitis B) with Clorox Healthcare Bleach Germicidal Wipes (EPA registration number 67619-12-5813). The sponsor provided studies to demonstrate that there was no change in performance of the test system after 1825 cleaning and disinfection cycles (one cycle includes one cleaning wipe plus one disinfecting wipe) to simulate 5 years of cleaning and disinfecting the meter 7 times per week. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures. 6. EMC testing was certified (by Quietek Corporation, Taiwan LTD) and compliance certificates provided documenting that acceptable electromagnetic testing (EMC) had been performed. 7. Customer service is available Monday through Friday 8:00 am to 5:00 pm CST by calling 1-800-261-7092. 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. 15