U-RIGHT TD-4279 BLOOD GLUCOSE MONITORING SYSTEM, FORA GD40/TD-4272 BLOOD GLUCOSE MONITORING SYSTEM

{0} 1 # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k101509 B. Purpose for Submission: New devices C. Measurand: Capillary and venous whole blood glucose D. Type of Test: Whole blood glucose concentration through a quantitative amperometric assay (GDH-FAD) E. Applicant: TaiDoc Technology Corporation F. Proprietary and Established Names: U-RIGHT TD-4279A Blood Glucose Monitoring System U-RIGHT TD-4279B Blood Glucose Monitoring System U-RIGHT TD-4279A MULTI Blood Glucose Monitoring System U-RIGHT TD-4279B MULTI Blood Glucose Monitoring System FORA GD40a/TD-4272a Blood Glucose Monitoring System FORA GD40b/TD-4272b Blood Glucose Monitoring System FORA Wisdom GD40a/TD-4272a Blood Glucose Monitoring System FORA Wisdom GD40b/TD-4272b 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, Blood Glucose Test System, Over-the-Counter LFR, Glucose Dehydrogenase 4. Panel: Clinical Chemistry (75) H. Intended Use: 1. Intended use(s): {1} See indication for use below. 2. Indication(s) for use: For single patient use U-RIGHT TD-4279A Blood Glucose Monitoring System The U-Right TD-4279A Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. This blood glucose monitoring system is intended to be used by a single person and should not be shared. The U-Right TD-4279A Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. The U-Right TD-4279 A Test Strips are for use with the U-Right TD-4279A Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. U-RIGHT TD-4279B Blood Glucose Monitoring System The U-Right TD-4279B Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. This blood glucose monitoring system is intended to be used by a single person and should not be shared. The U-Right TD-4279B Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. The U-Right TD-4279B Test Strips are for use with the U-Right TD-4279B Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. FORA GD40a Blood Glucose Monitoring System The FORA GD40a / TD-4272A Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. This blood glucose monitoring system is intended to be used by a single person and should not be shared. The FORA GD40a / TD-4272A Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. The FORA GD40a / TD-4272A Test Strips are for use with the FORA GD40a / TD-4272A Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. {2} 3 # FORA GD40b Blood Glucose Monitoring System The FORA GD40b / TD-4272B Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. This blood glucose monitoring system is intended to be used by a single person and should not be shared. The FORA GD40b / TD-4272B Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. The FORA GD40b / TD-4272B Test Strips are for use with the FORA GD40b / TD-4272B Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. ## For multiple patient use ## U-RIGHT TD-4279A MULTI Blood Glucose Monitoring System The U-Right TD-4279A MULTI Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from the fingertip. Testing is done outside the body (In Vitro diagnostic use). This system is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. This system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. The U-Right TD-4279A MULTI Test Strips are for use with the U-Right TD-4279A MULTI Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary and venous whole blood samples drawn from the fingertips. ## U-RIGHT TD-4279B MULTI Blood Glucose Monitoring System The U-Right TD-4279B MULTI Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from the fingertip. Testing is done outside the body (In Vitro diagnostic use). This system is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. This system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. The U-Right TD-4279B MULTI Test Strips are for use with the U-Right TD-4279B MULTI Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary and venous whole blood samples drawn from the fingertips. ## FORA Wisdom GD40a Blood Glucose Monitoring System The FORA Wisdom GD40a / TD-4272A Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from the fingertip. Testing is done outside {3} the body (In Vitro diagnostic use). This system is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancering devices. This system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. The FORA Wisdom GD40a / TD-4272A Test Strips are for use with the FORA Wisdom GD40a / TD-4272A Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary and venous whole blood samples drawn from the fingertips. ## FORA Wisdom GD40b Blood Glucose Monitoring System The FORA Wisdom GD40b / TD-4272B Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from the fingertip. Testing is done outside the body (In Vitro diagnostic use). This system is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancering devices. This system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. The FORA Wisdom GD40b / TD-4272B Test Strips are for use with the FORA Wisdom GD40b / TD-4272B Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary and venous whole blood samples drawn from the fingertips. ## 3. Special conditions for use statement(s): - Not intended for diagnosis or screening of diabetes mellitus - Over the Counter Use - U-RIGHT TD-4279A Blood Glucose Monitoring System, U-RIGHT TD-4279B Blood Glucose Monitoring System, FORA GD40a / TD-4272A Blood Glucose Monitoring System, FORA GD40b / TD-4272B Blood Glucose Monitoring System - Over the Counter and Prescription Use - U-RIGHT TD-4279A MULTI Blood Glucose Monitoring System, U-RIGHT TD-4279B MULTI Blood Glucose Monitoring System, FORA Wisdom GD40a / TD-4272A Blood Glucose Monitoring System, FORA Wisdom GD40b / TD-4272B Blood Glucose Monitoring System - Not intended for use on neonates - For in vitro diagnostic use only - Allows testing on the fingertip only - Not for use on patients who are dehydrated, hypotensive, in shock, or for individuals in hyperglycemic-hyperosmolar state, with or without ketosis. - Critically ill patients should not be tested with a blood glucose meter. ## 4. Special instrument requirements: U-RIGHT TD-4279A Blood Glucose Meter (USB model) U-RIGHT TD-4279B Blood Glucose Meter (Bluetooth model) U-RIGHT TD-4279A MULTI Blood Glucose Meter (USB model) U-RIGHT TD-4279B MULTI Blood Glucose Meter (Bluetooth model) {4} FORA GD 40a/TD-4272A Blood Glucose Meter (USB model) FORA GD 40b/TD-4272B Blood Glucose Meter (Bluetooth model) FORA Wisdom GD 40a/TD-4272A Blood Glucose Meter (USB model) FORA Wisdom GD 40b/TD-4272B Blood Glucose Meter (Bluetooth model) I. Device Description: The U-Right TD-4279 Blood Glucose Monitoring Systems (4 different models, see section H.4. above) and FORA GD40/TD-4272 Blood Glucose Monitoring Systems (4 different models, see section H.4. above) consist of: - Glucose meter - Test strips - One bottle control solution (Level 2) is included in the U-RIGHT TD-4279 A/B kit only. Additional control solutions (Levels 1 and 3) may be purchased separately. Controls were cleared previously in k093724. - Code strip - Quick start user guide - Daily log book - Warranty card - Batteries J. Substantial Equivalence Information: 1. Predicate device name(s): TaiDoc, FORA G31A/B Blood Glucose Monitoring System 2. Predicate k number(s): k094005 3. Comparison with predicate: | Item | Proposed Devices | | Predicate device FORA G31A/B (k094005) | | --- | --- | --- | --- | | | U-Right TD-4279A/B | FORA GD40a/b/ TD-4272A/B | | | Similarities | | | | | Intended use | In the quantitative measurement of glucose in fresh capillary and venous whole blood | Same | Same | | Detection method | Amperometry: current produced by chemical reaction | Same | Same | | Test range | 20 to 600 mg/dL | Same | Same | {5} | Altitude | 10,742 ft (3,275m) | Same | Same | | --- | --- | --- | --- | | Operating conditions | 50 -104 °F (10°C – 40°C), below 85% R.H. | Same | same | | Test time | 5 sec | Same | Same | | PC data transmission | Model AUSB cable Model B Bluetooth | Same | Same | | Memory feature | 1000 measurements | Same | Same | | Differences | | | | | Capillary Testing sites | finger only | Same as U-Right TD-4279 | finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the tight. | | Enzyme | Glucose Dehydrogenase (FAD) | Same as U-Right TD-4279 | Glucose Oxidase | | Test Strip Chemical Components | - Glucose dehydrogenase 8% - Electron shuttle 55% - Enzyme protector 8% - Non-reactive ingredients 29% | Same as U-Right TD-4279 | - Glucose oxidase (A. niger) 13% - Electron shuttle 39% - Enzyme protector 6% - Non-reactive ingredients 42% | | Hematocrit | 20 % – 70 % | Same as U-Right TD-4279 | 20% - 60% | | Test sample | Whole blood from fingertip and venous blood (Capillary for home-use and capillary and venous for professional-use) | Same as U-Right TD-4279 | Whole blood from fingertip, palm, forearm, upper-arm, calf and tight | | Coding function | Automatic calibration by code strip | Same as U-Right TD-4279 | No coding | | Code number | Displayed | Same as U-Right TD-4279 | Not displayed | | Sample volume | 1.1 μl | Same as U-Right TD-4279 | 0.5 μl | | Storage conditions | 35.6°F- 89.6°F (2°C - 32°C) | Same as U-Right TD-4279 | 39.6°F- 89.6°F (4°C - 32°C) | {6} | | below 85% R.H.) | | below 85% R.H.) | | --- | --- | --- | --- | | Size L x W x H (mm) | 94.9 X 52 X 15 | 94.9 X 52 X 15 | 85 X 52 X 15 | | Weight | 67.6 g | 71 g | 95 g | ## K. Standard/Guidance Document Referenced (if applicable): - ISO 14971:2007. Medical devices—Application of risk management to medical devices. - ISO 15197. In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. - EN 60601-1-1. Medical electrical equipment, Part 1-1. General requirements for safety. Safety requirements for medical electrical systems. - EN 60601-1-2:2001 (A1:2006). Medical electrical equipment, Part 1-2. General requirements for basic safety and essential performance. Electromagnetic Compatibility. - EN 61326-1:2006. Electrical equipment for measurement, control, and laboratory use. EMC Requirements. General requirements. - IEC/EN 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. ## L. Test Principle: The U-Right TD-4279 and FORA GD 40 glucose meters, in conjunction with the same test trips (U-Right TD-4279 or FORA GD-40), utilize amperometric technology to quantitatively measure the glucose concentration in whole blood samples and in control solutions. A glucose dehydrogenase sensor based on the carbon electrode adopting the amperometric assay utilizes the enzyme glucose dehydrogenase to catalyze the formation of gluconolactone from the oxidation of glucose whereby two electrons are produced. Through the mechanism of the mediator, electrical current is generated and it is proportional to the quantity of glucose in the sample. The reaction principle of reagent depends on following reaction equation: $$ \text{GDH, FAD} $$ $$ \text{Glucose} + 2 \text{ferricyanide} = \text{gluconolactone} + 2 \text{ferrocyanide} $$ $$ \text{electrode} $$ $$ \text{ferrocyanide} = \text{ferricyanide} + \text{e-} $$ - GDH: glucose dehydrogenase - FAD: flavin adenine dinucleotide ## M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: {7} The sponsor performed precision studies in accordance with the ISO 15197 and CLSI EP-5A. Since the U-Right TD-4279A and U-Right TD-4279B are identical devices as well as FORA GD40 A and FORA GD40 B, which differ only in data transmission function (A - USB model; B - Bluetooth model), the precision studies were performed to evaluate precision of the glucose meters with more complex data transmission function, the U-Right TD-4279B and FORA GD40 B models. The within-run precision study was performed using venous whole blood samples, with hematocrit ranging from 38% to 54%, and dextrose spiked to create 7 levels of blood glucose. Three lots of test strips and 10 meters were used in the study, with 10 tests performed on each meter for a total of 300 tests per blood glucose level. Results for each test strip lot are summarized in the tables below: Within Day: U-Right TD-4279 Lot 1 | Samples | Number of Tests | Mean (mg/dL) | Standard Deviation (mg/dL) | Coefficient of variation (%) | | --- | --- | --- | --- | --- | | Level 1 | 100 | 22.9 | 1.87 | 8.17 | | Level 2 | 100 | 39.4 | 2.25 | 5.71 | | Level 3 | 100 | 90.5 | 2.67 | 2.96 | | Level 4 | 100 | 142.5 | 4.7 | 3.30 | | Level 5 | 100 | 178.5 | 6.34 | 3.55 | | Level 6 | 100 | 310.3 | 13.97 | 4.5 | | Level 7 | 100 | 576.2 | 13.66 | 2.37 | Lot 2 | Samples | Number of Tests | Mean (mg/dL) | Standard Deviation (mg/dL) | Coefficient of variation (%) | | --- | --- | --- | --- | --- | | Level 1 | 100 | 21.4 | 1.61 | 7.52 | | Level 2 | 100 | 33.9 | 1.87 | 5.52 | | Level 3 | 100 | 87.0 | 3.18 | 3.65 | | Level 4 | 100 | 134.1 | 5.75 | 4.29 | | Level 5 | 100 | 176.3 | 6.45 | 3.55 | | Level 6 | 100 | 307.2 | 10.63 | 3.46 | | Level 7 | 100 | 582.6 | 14.99 | 2.57 | {8} Lot 3 | Samples | Number of Tests | Mean (mg/dL) | Standard Deviation (mg/dL) | Coefficient of variation (%) | | --- | --- | --- | --- | --- | | Level 1 | 100 | 21.6 | 1.89 | 8.75 | | Level 2 | 100 | 38.0 | 1.48 | 3.89 | | Level 3 | 100 | 88.6 | 1.95 | 2.20 | | Level 4 | 100 | 134.1 | 5.01 | 3.74 | | Level 5 | 100 | 176.3 | 4.41 | 2.51 | | Level 6 | 100 | 301.01 | 6.6 | 2.19 | | Level 7 | 100 | 580.3 | 15.25 | 2.63 | FORA GD40: Lot 1 | Samples | Number of Tests | Mean (mg/dL) | Standard Deviation (mg/dL) | Coefficient of variation (%) | | --- | --- | --- | --- | --- | | Level 1 | 100 | 24.4 | 1.50 | 6.14 | | Level 2 | 100 | 35.7 | 2.58 | 7.23 | | Level 3 | 100 | 93.0 | 3.44 | 3.70 | | Level 4 | 100 | 129.2 | 2.85 | 2.21 | | Level 5 | 100 | 197.7 | 6.87 | 3.48 | | Level 6 | 100 | 367.7 | 6.87 | 1.87 | | Level 7 | 100 | 578.7 | 16.82 | 2.91 | Lot 2 | Samples | Number of Tests | Mean (mg/dL) | Standard Deviation (mg/dL) | Coefficient of variation (%) | | --- | --- | --- | --- | --- | | Level 1 | 100 | 24.6 | 1.37 | 5.57 | | Level 2 | 100 | 37.3 | 3.29 | 8.82 | | Level 3 | 100 | 93.1 | 2.58 | 2.77 | | Level 4 | 100 | 132.8 | 4.71 | 3.54 | | Level 5 | 100 | 198.4 | 8.99 | 4.53 | | Level 6 | 100 | 368.4 | 8.99 | 2.44 | | Level 7 | 100 | 579.3 | 15.42 | 2.66 | {9} Lot 3 | Samples | Number of Tests | Mean (mg/dL) | Standard Deviation (mg/dL) | Coefficient of variation (%) | | --- | --- | --- | --- | --- | | Level 1 | 100 | 23.3 | 1.89 | 8.11 | | Level 2 | 100 | 37.8 | 3.12 | 8.25 | | Level 3 | 100 | 94.8 | 3.25 | 3.43 | | Level 4 | 100 | 132.8 | 3.51 | 2.65 | | Level 5 | 100 | 198.3 | 9.28 | 4.69 | | Level 6 | 100 | 368.4 | 9.92 | 2.69 | | Level 7 | 100 | 578.4 | 16.54 | 2.86 | In addition, the sponsor also evaluated day-to-day precision using venous samples with 6 glucose concentrations collected in commercially available sodium-heparin tubes. Three lots of test strips and 10 meters were used in the study, with 1 test performed on each meter per day for 10 days, for a total of 100 tests per control level. Results for each test strip lot are summarized in the tables below: Between Day: U-Right TD-4279: Lot 1 | Samples | Number of Tests | Mean (mg/dL) | Standard Deviation (mg/dL) | Coefficient of variation (%) | | --- | --- | --- | --- | --- | | Level 1 | 100 | 22.6 | 1.68 | 7.43 | | Level 2 | 100 | 36.4 | 2.25 | 6.18 | | Level 3 | 100 | 115.5 | 2.67 | 2.32 | | Level 4 | 100 | 370.3 | 13.97 | 3.77 | | Level 5 | 100 | 430.3 | 13.97 | 3.25 | | Level 6 | 100 | 591.3 | 14.21 | 2.4 | Lot 2 | Samples | Number of Tests | Mean (mg/dL) | Standard Deviation (mg/dL) | Coefficient of variation (%) | | --- | --- | --- | --- | --- | | Level 1 | 100 | 21.9 | 2.15 | 9.82 | | Level 2 | 100 | 30.9 | 1.87 | 6.05 | | Level 3 | 100 | 112.0 | 3.18 | 2.84 | | Level 4 | 100 | 367.2.4 | 10.63 | 2.89 | | Level 5 | 100 | 427.2 | 10.63 | 2.49 | | Level 6 | 100 | 581.4 | 19.37 | 3.33 | {10} Lot 3 | Samples | Number of Tests | Mean (mg/dL) | Standard Deviation (mg/dL) | Coefficient of variation (%) | | --- | --- | --- | --- | --- | | Level 1 | 100 | 21.9 | 2.21 | 10.09 | | Level 2 | 100 | 35.0 | 1.48 | 4.23 | | Level 3 | 100 | 113.6 | 1.95.6 | 1.72 | | Level 4 | 100 | 361.6 | 6.6 | 1.83 | | Level 5 | 100 | 421.0 | 6.6 | 1.57 | | Level 6 | 100 | 588.6 | 18.98 | 3.22 | FORA GD40: Lot 1 | Samples | Number of Tests | Mean (mg/dL) | Standard Deviation (mg/dL) | Coefficient of variation (%) | | --- | --- | --- | --- | --- | | Level 1 | 100 | 23.5 | 2.10 | 8.94 | | Level 2 | 100 | 33.0 | 3.44 | 10.42 | | Level 3 | 100 | 121.2 | 2.85 | 2.36 | | Level 4 | 100 | 317.7 | 6.87 | 2.16 | | Level 5 | 100 | 386.3 | 8.08 | 2.09 | | Level 6 | 100 | 589.9 | 16.34 | 2.77 | Lot 2 | Samples | Number of Tests | Mean (mg/dL) | Standard Deviation (mg/dL) | Coefficient of variation (%) | | --- | --- | --- | --- | --- | | Level 1 | 100 | 24.2 | 2.61 | 10.79 | | Level 2 | 100 | 33.1 | 2.58 | 7.79 | | Level 3 | 100 | 124.8 | 4.71 | 3.77 | | Level 4 | 100 | 318.4 | 8.99 | 2.82 | | Level 5 | 100 | 385.3 | 8.89 | 2.31 | | Level 6 | 100 | 585.3 | 13.12 | 2.24 | Lot 3 | Samples | Number of Tests | Mean (mg/dL) | Standard Deviation (mg/dL) | Coefficient of variation (%) | | --- | --- | --- | --- | --- | | Level 1 | 100 | 24.5 | 2.29 | 9.35 | | Level 2 | 100 | 34.8 | 3.25 | 9.33 | | Level 3 | 100 | 124.8 | 3.51 | 2.82 | | Level 4 | 100 | 318.4 | 9.92 | 3.12 | | Level 5 | 100 | 383.1 | 7.59 | 1.98 | | Level 6 | 100 | 598.8 | 12.59 | 2.10 | {11} b. Linearity/assay reportable range: The sponsor performed linearity studies using adjusted whole blood samples with 11 different glucose concentrations covering the measuring range entirely and using both devices, U-Right TD-4279 (B model) and FORA GD40 (B model) and the YSI-2300 glucose analyzer (reference method). Three lots of test strips were used in the study with 20 tests per lot performed on each meter. Linear regression analysis for each test strip lot is summarized below: U-Right TD-4279: Lot 1 $y = 0.9833x + 6.2548, r^2 = 0.9974$ Lot 2 $y = 0.9734x + 7.5126, r^2 = 0.9981$ Lot 3 $Y = 0.9707x + 8.0857, r^2 = 0.9952$ FORA GD40: Lot 1 $y = 1.0339x - 0.5722, r^2 = 0.9944$ Lot 2 $y = 1.0109x + 2.1511, r^2 = 0.9952$ Lot 3 $Y = 1.0089 + 5.2186, r^2 = 0.9879$ The measuring range of the U-Right TD-4279 and FORA GD40 is 20 - 600 mg/dL. c. Traceability, Stability, Expected values (controls, calibrators, or methods): The method comparison was performed using the proposed devices and YSI 2300 glucose analyzer. Controls: Control solutions were cleared in k093724. The control ranges are listed on the test strip vial labels. The storage claims for these devices are: 90 days for open vial of strips stored at $35.6 - 89.6^{\circ}\mathrm{F}$ $(2 - 32^{\circ}\mathrm{C})$ and 18 months for unopened vials of strips stored at the same temperature. The study protocol, data and acceptance criteria were provided and found to be adequate. Temperature and humidity studies: Temperature and humidity studies were conducted on each type of meter (U-Right TD-4279 and FORA GD40) with venous blood samples spanning the measuring range and demonstrating that these devices can be used at temperatures of 4 to $40^{\circ}\mathrm{C}$ and at a relative humidity up to $85\%$. The study protocol, data and individual bias of $\pm 10\%$ across the entire measuring range were provided and found to be adequate. Open-vial-in-use test strip studies were performed at the combined extremes of $10 \pm 2^{\circ} \mathrm{C}$ (46.4-56.3°F) RH: $30\%$, $10 \pm 2^{\circ} \mathrm{C}$ RH: $85\%$, $40 \pm 2^{\circ} \mathrm{C}$ (100.4-107.6°F) RH: $30\%$, and $40 \pm 2^{\circ} \mathrm{C}$ RH: $85\%$ with venous blood samples with concentrations across the measuring range and compared to the YSI. The study protocol, data and individual bias of $\pm 10\%$ across the entire measuring range were provided and found to be adequate. 12 {12} d. Detection limit: The measuring range of the devices is $20 - 600\mathrm{mg / dL}$ . This range was validated via the linearity study (see section M.1.b.). e. Analytical specificity: The sponsor performed interference studies with spiked venous blood samples at two glucose concentrations (100 and $300\mathrm{mg / dL}$ ) that were prepared and divided into a test (dosed) pool and a control pool. The interferents were added to the sample and each sample was analyzed in duplicate using 4 U - Right TD-4279 and FORA GD40 glucose meters. The table below lists all substances tested at concentrations with insignificant (&lt;10%) interference: | Substance | Concentration with <10% interference (mg/dL) | | --- | --- | | Acetaminophen | 5 | | Acetylsalicylic acid | 50 | | Acyclovir | 3.1 | | Allopurinol | 5 | | Amitriptyline | 0.25 | | Amoxicillin | 11 | | Ampicillin | 5 | | Ascorbic acid | 4 | | Aspirin | 60 | | Atenolol | 10 | | Bicarbonate | 336 mM | | Bile acids | 6 | | Bilirubin | 20 | | Caffeine | 10 | | Calcium | 5 mM | | Chloride | 140 mM | | Cholesterol | 500 | | Clonidine | 2 | | Creatinine | 5 | | Digoxin | 0.16 | | Diphenhydramine | 1 | | Dopamine | 1.25 | | Enalapril | 0.15 | | Erythromycin | 20 | | Estrone | 0.1 | | Famotidine | 0.13 | | Fluoxetine | 0.8 | | Fructose | 1000 | {13} | Furosemide | 2 | | --- | --- | | Galactose | 1000 | | Gentisic acid | 2 | | Glyburide | 1.07 | | Hemoglobin | 500 | | Heparin | 6800 U/dL | | Ibuprofen | 55 | | Lactose | 1000 | | L-dopa | 0.7 | | Lidocaine | 6 | | Magnesium | 5 mM | | Mannitol | 1000 | | Mannose | 250 | | Maltose | 1000 | | Metaproterenol | 1.81 | | Methyl-dopa | 0.625 | | Metoprolol | 0.3 | | Naproxen | 100 | | Nifedipine | 0.17 | | Nortriptyline | 0.15 | | Penicillin | 12 | | pH | 6.85 – 10.35 | | Phenytoin | 10 | | Piroxicam | 5 | | Potassium | 10 mM | | Pralidoxime | 5 | | Sodium | 200 mM | | Sorbitol | 1000 | | Sulfamethoxazole | 120 | | Sulfate | 5 mM | | Terfenadine | 0.45 | | Tetracycline | 4 | | Theophylline | 25 | | Tolazamide | 6.25 | | Tolbutamide | 64 | | Total protein | 12000 | | Triglycerides | 2000 | | Urea | 600 | | Uric acid | 10 | | Vancomycin | 25 | | Verapamil | 0.45 | | Vitamin E | 20 | | Warfarin | 2 | | Xylose | 6.25 | 14 {14} Hematocrit Study: A study to evaluate the effect of hematocrit was conducted on samples with 8 glucose concentrations at 11 hematocrit levels (20, 25, 30, 35, 40, 45, 50, 55, 60, 65 and 70%). Each glucose level/hematocrit combination was tested in duplicate of 6 of each type of meter (U-Right TD-4279 and FORA GD40) using one lot of test strips. Results of samples at each hematocrit level were compared to samples with the same glucose concentration at normal (40%) hematocrit as well as to the corresponding YSI value. All individual results for each meter type were +/- 15% of the YSI, supporting the claimed hematocrit range of 20-70%. f. Assay cut-off: Not applicable 2. Comparison studies: a. Method comparison with predicate device: The sponsor conducted a combined accuracy and consumer study. Testing was performed at 3 sites, with trained operators and a total of 146 lay-users. Each lay user participant performed their own fingerstick and tested their blood on the U-Right TD-4279 and FORA GD40 (TD-4272) meters using only the instructions in the user's manual and test strip insert. A trained operator then performed a second fingerstick and tested the blood on the same meter. Venous blood was also collected and measured on an YSI analyzer. The total range of samples tested was 32-539 mg/dL for the U-Right TD-4279 meter and 32 to 512 mg/dL for the FORA GD40 (TD-4272) glucose meter. Samples &lt;40 mg/dL and &gt;400 mg/dL were glycolyzed or spiked, respectively, and tested by trained operators as well as lay users. Linear regression results are presented below: U-Right TD-4279: Professional vs YSI y = 1.0452x + 2.2323, r² = 0.9954 Lay user vs. YSI y = 1.0701x - 2.0936, r² = 0.9951 FORA GD40 (TD-4272): Professional vs YSI y = 1.0644x - 3.4426, r² = 0.9574 Lay user vs. YSI y = 1.0819x - 7.6905, r² = 0.9680 The study results met the ISO 15197 accuracy criteria where ninety-five percent (95%) of the individual glucose results fell within ±15mg/dL of the YSI results at glucose concentrations &lt;75mg/dL and within ±20% at glucose concentrations ≥75mg/dL. 15 {15} For glucose concentrations $&lt; 75\mathrm{mg / dL}$ | U-Right TD-4279 | within ± 5 mg/dL | within ± 10 mg/dL | within ± 15 mg/dL | | --- | --- | --- | --- | | Professionals | 23/24 (96%) | 24/24 (100%) | 24/24 (100%) | | Lay user | 16/24 (67%) | 24/24 (100%) | 24/24 (100%) | For glucose concentrations $\geq 75\mathrm{mg / dL}$ | U-Right TD-4279 | within ± 5 % | within ± 10 % | Within ± 15 % | within ± 20 % | | --- | --- | --- | --- | --- | | Professionals | 26/122 (21%) | 108/122 (89%) | 122/122 (100%) | 122/122 (100%) | | Lay user | 32/122 (26%) | 101/122 (83%) | 122/122 (100%) | 122/122 (100%) | For glucose concentrations $&lt; 75\mathrm{mg / dL}$ | GD 40/TD-4272 | within ± 5 mg/dL | within ± 10 mg/dL | within ± 15 mg/dL | | --- | --- | --- | --- | | Professionals | 21/24 (88%) | 24/24 (100%) | 24/24 (100%) | | Lay user | 22/24 (92%) | 24/24 (100%) | 24/24 (100%) | For glucose concentrations $\geq 75\mathrm{mg / dL}$ | GD 40/TD-4272 | within ± 5 % | within ± 10 % | within ± 15 % | within ± 20 % | | --- | --- | --- | --- | --- | | Professionals | 100/122 (82%) | 113/122 (93%) | 122/122 (100%) | 122/122 (100%) | | Lay user | 81/122 (67%) | 113/122 (93%) | 122/122 (100%) | 122/122 (100%) | # b. Matrix comparison: Venous blood samples: Testing was done comparing venous blood samples previously collected in commercially available sodium-heparin tubes and then evaluated with the U-Right TD-4279 and FORA GD40 against YSI-2300. 100 subjects were tested by professionals. Samples from 25 to $560\mathrm{mg / dL}$ for the U-Right TD-4279 BGM and 22 to $584\mathrm{mg / dL}$ for the FORA GD40 were included in this analysis. Each fresh capillary whole blood sample used was from a different individual except for samples with blood glucose concentrations less than 40 $\mathrm{mg / dL}$ and greater than $400\mathrm{mg / dL}$ . For those specimens, a pooled capillary whole blood specimen was either glycolyzed or spiked to the desired level. Linear regression results are presented below: {16} U-Right TD-4279: $y = 0.9912x + 0.6364, r^2 = 0.9826$ FORA GD40/TD-4272: $y = 0.9769x + 2.0365, r^2 = 0.9803$ The study results met the ISO 15197 accuracy criteria where ninety-five percent (95%) of the individual glucose results fell within ±15mg/dL of the YSI results at glucose concentrations &lt;75mg/dL and within ±20% at glucose concentrations ≥75mg/dL. For glucose concentrations &lt; 75 mg/dL | | within ± 5 mg/dL | within ± 10 mg/dL | within ± 15 mg/dL | | --- | --- | --- | --- | | U-Right TD-4279 | 15/20 (75%) | 20/20 (100%) | 20/20 (100%) | | FORA GD40 (TD-4247) | 11/20 (55%) | 19/20 (95%) | 20/20 (100%) | For glucose concentrations ≥ 75 mg/dL | | within ± 5 % | within ± 10 % | within ± 15 % | within ± 20 % | | --- | --- | --- | --- | --- | | U-Right TD-4279 | 28/80 (35%) | 68/80 (93%) | 78/80 (98%) | 80/80 (100%) | | GD 40/ TD-4272 | 33/80 (41%) | 63/80 (88%) | 76/80 (95%) | 80/80 (100%) | 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): Not applicable 4. Clinical cut-off: Not applicable 5. Expected values/Reference range: In the labeling the sponsor presents expected blood glucose levels for people without diabetes (referenced from the American Diabetes Association, Clinical {17} Practice Recommendations. (2010). Diabetes Care, Vol. 33, Supplement 1, p. S1-S100. | Time | Range (mg/dL) | Range (mmol/L) | | --- | --- | --- | | Fasting and before meals | Less than 100mg/dL | 5.6mmol/L | | Two hours after meals | Less than 140 mg/dL | 7.8 mmol/dL | N. Instrument Name: - U-RIGHT TD-4279A Blood Glucose Meter (USB model) - U-RIGHT TD-4279B Blood Glucose Meter (Bluetooth model) - U-RIGHT TD-4279A MULTI Blood Glucose Meter (USB model) - U-RIGHT TD-4279B MULTI Blood Glucose Meter (Bluetooth model) - FORA GD 40a/TD-4272A Blood Glucose Meter (USB model) - FORA GD 40b/TD-4272B Blood Glucose Meter (Bluetooth model) - FORA Wisdom GD 40a/TD-4272A Blood Glucose Meter (USB model) - FORA Wisdom GD 40b/TD-4272B Blood Glucose Meter (Bluetooth model) O. Systems Descriptions: 1. Modes of Operation: Each test strip is single use and must be replaced with a new strip for additional readings. Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device?: ☐ Yes ☑ X or No (CLEVER CHECK Health Care System Software cleared under k070941) Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission? ☐ Yes ☑ X or No 2. Software: FDA 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: Professionals may test capillary and venous blood, while home-use is limited to capillary whole blood testing only. 18 {18} 5. Calibration: These systems need to be calibrated every time users open a new vial of test strips. Calibration of the test strip is done by inserting the code strip into the meters when opening a new vial of test strips 6. Quality Control: The sponsor has three levels of controls that may not be provided with the meters, but can be purchased separately. When a test strip is inserted into the meter, each control can be measured by following the instructions for “Performing a Control Solution Test” provided in the User’s Manuals for the meters. An acceptable range for each control level is printed on the test strip vial label. If the test results fall outside the range printed on the test strip vial, the user is instructed to contact the Customer Care Line at 1-866-469-2632 for customer support. The Customer Care service is available 24 hours a day, 7 days a week, 365 days a year. P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above: 1. These devices are intended for single-patient use (U- RIGHT TD-4279A/B and FORA GD 40a/b/TD-4247A/B) and multiple patient use/healthcare professional use (U- RIGHT TD-4279A/B MULTI and FORA Wisdom GD 40a/b/TD-4247A/B). Cleaning and disinfection are different processes. Cleaning is the process of removing dirt (e.g. food debris, grease, dust), disinfection is the process of killing germs (e.g. bacteria and viruses). Disinfection studies (viral efficacy studies) were performed by an outside service to evaluate the virus elimination effectiveness of disinfecting wipes in preventing the spread of bloodborne pathogens, particularly hepatitis B virus (HBV). Specifically, MicroKill+ cleaner disinfectant towels (with EPA registration # 59894-10-37549) were validated demonstrating complete inactivation of live virus. The sponsor does not market a lancing device for use with the device. The sponsor also performed robustness studies using all 4 glucose meters claimed in this 510(k) application (U- RIGHT TD-4279A, U- RIGHT TD-4279B, FORA GD 40a/TD-4247A and FORA GD 40b/TD-4247B) and demonstrated that there was no change in performance or in the external materials of the meters after 10,000 cleaning and disinfection cycles designed to simulate 5 years (5 cleaning and disinfection cycles per day) of single patient device use or 3 years (9 cleaning and disinfection cycles per day) of healthcare professional use. The tested number of cycles is estimated by 5 cleaning and disinfection cycles per day over 5 years, the expected life of the single patient device or 9 cycles per day for the multiple patient use in professional settings. In addition, the sponsor provided a risk analysis specific to the potential harm due to infection. Labeling has been reviewed for adequate instructions in validated cleaning and disinfection procedures. 2. Lay-User Study for USB and Bluetooth mediated Data Transmission: This study was performed using 50 study participants, following instructions in 19 {19} User's manual, who were able to transmit results from the meter to the PC application (cleared under k070941) via either the USB (25 study subjects) or Bluetooth (25 study subjects) features. The study participants also completed a questionnaire in response to whether the data transmission feature is easy to use. The sponsor concluded that the users' responses indicated that data transmission function was easy to operate by following the User's manuals for both the USB and the Bluetooth mediated data transmission. 3. Altitude study: An altitude study was performed in an altitude simulation chamber with whole blood samples spanning the range of ~20 to 600 mg/dL for both, U-Right TD-4279 and FORA GD40 glucose meters. The study protocol, data and bias ±10% across the entire measuring range were provided and found to be adequate. Altitude up to 10,742 feet (3,275m) does not affect test results of the U-RIGHT TD-4279 and FORA GD40 glucose meters. 4. Specimen volume study: A study was performed to evaluate the effect of different sample volumes (0.8, 0.9, 1.0, 1.1, 1.2, 2.0 and 2.5μl) on the performance of these devices. It was determined that the 1.1 μl volume of sample provides accurate reading for both, U-RIGHT TD-4279 and FORA GD40 glucose meters. The results from this study for the sample volume of 1.1 μl were within ±10% individual bias across the entire measuring range when U-RIGHT TD-4279 and FORA GD40 measurements were compared to the YSI-2300. 5. The sponsor provided a readability study and obtained Flesch-Kincaid grade level scores of 8 or lower for the User's Manual and test strip insert. 6. Lay user questionnaire: 146 lay users evaluated the ease of use of the device and the presentation of the labeling. All users thought that the U-Right TD-4279 and FORA GD40 Blood Glucose Monitoring Systems were easy to use and most answer "easy" and "very easy" that the user manuals were written to make it easy to use. 7. Additional electromagnetic interference study was performed to verify these new products. The results of this study complied with standards listed in the Standard/Guidance Document Referenced section above. Electromagnetic Compatibility (EMC): EMC testing for u-Right TD-4279 and FORA GD40 was performed/passed and a certificate to TaiDoc was provided. 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. 20