BLOOD GLUCOSE MONITORING SYSTEM

K043543 · American Healthcare, Inc. · NBW · Apr 8, 2005 · Clinical Chemistry

Device Facts

• Record ID: K043543
• Device Name: BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: American Healthcare, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Apr 8, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Indications for Use

The Freedom Blood Glucose Monitoring System is used for the quantitative measurement of glucose level in whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. The Freedom Blood Glucose Monitoring System is for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip testing along with alternate site testing on the arm, palm, thigh, and calf.

Device Story

System uses electrochemical biosensor technology to measure glucose in whole blood; utilizes glucose oxidase enzyme on carbon electrodes. User applies blood sample to test strip; meter performs amperometric measurement; displays quantitative glucose result. Used in home or clinical settings by patients or healthcare professionals. Provides plasma-equivalent results; includes memory function for tracking averages and test history. Benefits patient by enabling self-monitoring of blood glucose levels for diabetes management.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics to predicate devices.

Technological Characteristics

In vitro diagnostic device; electrochemical sensing principle using dehydrogenase glucose reaction; generates electrical current proportional to glucose concentration; handheld meter form factor; intended for home and clinical use.

Indications for Use

Indicated for quantitative blood glucose measurement in patients with diabetes to monitor management effectiveness. Suitable for home and clinical use. Testing sites include fingertip, arm, palm, thigh, and calf.

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• LifeScan, Inc. OneTouch® Ultra® (K024194)
• LifeScan, Inc. SURESTEP® (K984261)
• Roche Diagnostics Corp. Accu-Chek Advantage (K021513)

Submission Summary (Full Text)

{0}

Page 1 of 16

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY DEVICE ONLY TEMPLATE

A. 510(k) Number: k043543

B. Purpose For Submission:

Premarket Notification 510(k) of intention to manufacture and market the Freedom Blood Glucose Monitoring System.

C. Analyte: Whole Blood Glucose

D. Type of Test: Quantitative, utilizing Glucose Oxidase technology.

E. Applicant: American HealthCare, Inc.

F. Proprietary and Established Names: Freedom 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, CGA
4. Panel: 75 Chemistry

H. Intended Use:

1. Intended use(s):

See Indications for use below.

2. Indication(s) for use:

The Freedom Blood Glucose Monitoring System is used for the quantitative measurement of glucose level in whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. The Freedom Blood Glucose Monitoring System is for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip testing along with alternate site testing on the arm, palm, thigh, and calf.

{1}

Page 2 of 16

3. Special condition for use statement(s):

Provides plasma equivalent results.

4. Special instrument requirements:

Freedom Blood Glucose Monitoring System

I. Device Description:

The Freedom Blood Glucose Monitoring System consists of the Freedom Meter, Freedom Test Strips, Auto-Lancet Device, Infopia Check Strip and Greenlan Lancets, Control Solution. Control Solution is sold separately from the kit. Control solution was cleared previously in k031501.

J. Substantial Equivalence Information:

1. Predicate device name(s):

LifeScan, Inc. OneTouch Ultra®

2. Predicate K number(s):

k024194

3. Comparison with Predicate:

The US Diagnostics, Inc. Freedom Blood Glucose Monitoring System is substantially equivalent to the LifeScan. Inc. ONE TOUCH Ultra® Blood Glucose Monitoring System previously cleared under (k024194). The table below lists the similarities and differences between the predicate and proposed device.

Similarities

| | Freedom | ONE TOUCH® Ultra® |
| --- | --- | --- |
| Detection Method | Amperometry: current is generated by oxidation of reduced mediator. | Amperometry |
| Enzyme | Glucose Oxidase (Aspergillus niger) | Glucose Oxidase (Aspergillus niger) |
| Mediator | Hexaammineruthenium chloride | Potassium ferricyanide |
| Electrode | Carbon electrode | Carbon electrode |

The other ingredients of test strip, such as enzyme stabilizer, buffer and binder are different.

{2}

The Freedom Blood Glucose Monitoring System provides the same glucose monitoring capability as the predicate device, the ONE TOUCH® Ultra®. The primary differences are in the advanced memory function and battery lifetime.

Differences

| | Freedom | ONE TOUCH® Ultra® |
| --- | --- | --- |
| Test range | 10 ~ 600 mg/dL | 20 ~ 600 mg/dL |
| Hematocrit Range | 30 ~55% | 30 ~ 55% |
| Test Time | 5 seconds | 5 seconds |
| Sample Volume | 1uL | 1uL |
| Temperature & Humidity range | 50 ~ 104°F 10 ~ 40°C 10 ~ 90% | 43 ~ 111°F 6 ~ 44°C 10 ~ 90% |
| Open use time | 3 months | 3 months |
| Coding | Button (C1 ~C45) | Button (C1 ~ C49) |
| Memory capability | From 7 to 99-day average and 250 tests in the memory | 14-day average and last 150 tests in the memory |
| Power | 3V Li battery (CR2032) | 3V Li battery (CR2032) |
| Battery life | Running 5,000 test | Running 1,000 test |
| Size: LxWxH (mm) | 91x54.5x22.8 | 79x57x21 |
| Weight | 55g(with battery) | 42g (with battery) |
| Warranty | Lifetime | 3 years |
| Software | Freedom diabetes management software | IN TOUCH® diabetes management software |

# K. Standard/Guidance Document Referenced (if applicable):

1) National Committee for Clinical Laboratory Standards. Point-Care Blood Glucose Testing in Acute and Chronic care Facilities; Approved Guideline, $2^{\text{nd}}$ Edition. NCCLS Document C30-A2 (ISBN1-56238-471-6).
2) National Committee for Clinical Laboratory Standards. Statistical Quality Control for Quantitative Measurements; Principle and Definitions; Approved Guideline, $2^{\text{nd}}$ Edition. NCCLS Document C24-A2 (ISBN1-56238-371-X). 1999
3) National Committee for Clinical Laboratory Standards. Preliminary Evaluation of Quantitative Clinical Laboratory Methods; Approved Guideline. NCCLS Document EP10-A (ISBN1-56238-348-5). 1998
4) National Committee for Clinical Laboratory Standards. Evaluation of Matrix Effects; Approved Guideline, NCCLS Document EP14-A (ISBN1-56238-434-1).

{3}

Page 4 of 16

5) National Committee for Clinical Laboratory Standards. Estimation of Total analytical Error for Clinical Laboratory Methods; Proposed Guideline. NCCLS Document EP21-P (ISBN1-56238-456-2).

6) National Committee for Clinical Laboratory Standards. User Demonstration of performance for Precision and Accuracy; Approved Guideline. NCCLS Document EP15-A (ISBN1-56238-451-1).

7) National Committee for Clinical Laboratory Standards. Interference Testing in Clinical Chemistry; Proposed Guideline. NCCLS Document EP7-P (ISSN 0273-3099).

8) National Committee for Clinical Laboratory Standards. Evaluation of the Linearity of Quantitative Analytical Methods; Proposed Guideline, 2nd Edition. NCCLS Document EP6-P2 (ISBN1-56238-446-5).

9) National Committee for Clinical Laboratory Standards. Evaluation of Performance of Clinical Chemistry Devices; Approved Guideline. NCCLS Document EP5-A (ISBN1-56238-368-X).

10) Clinical Chemistry, 2nd Edition

11) MERCK INDEX, 11th Edition.

L. Test Principle:

The Test Principle used by this device is electrochemical biosensor technology using Glucose Oxidase. The strip uses the enzyme Glucose Oxidase to produce an electrical current that will stimulate a chemical reaction. This reaction is measured by the Freedom meter and displayed as a blood glucose result.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

The sponsor indicated precision studies were assessed by taking 4 mL of blood that was treated with EDTA drawn in a vacuum tube. Glucose was added to the 4 mL of blood to generate 5 different levels of glucose concentration for the test. Each of the samples was measured 5 times for precision.

Day-to-Day precision also known as Between Day Precision

The sponsor prepared three control solutions of Low, Normal and High. Each of the controls was measured twice a day, once in the morning and once in the afternoon for a month.

{4}

Table 1 (below) shows a summary of the Within-Run Precision and the Day-to-Day Precision Tests.
Table 1: Summary of Test Results

| Control Samples | No. of Assay | Within-Run Precision | | |
| --- | --- | --- | --- | --- |
| | | Mean (mg/dL) | SD (mg/dL) | CV (%) |
| Level 1 | 5 | 43 | 1.6 | 3.7 |
| Level 2 | 5 | 81.6 | 2.1 | 2.5 |
| Level 3 | 5 | 132.6 | 1.9 | 1.5 |
| Level 4 | 5 | 211.6 | 5.9 | 2.8 |
| Level 5 | 5 | 318.2 | 12 | 3.8 |
| Control Samples | Day-to-Day Precision | | | |
| --- | --- | --- | --- | --- |
| | No. of Assay | Mean (mg/dL) | SD (mg/dL) | CV (%) |
| Low | 80 | 50.4 | 2.0 | 3.9 |
| Normal | 80 | 122.7 | 2.6 | 2.1 |
| High | 80 | 321.7 | 7.0 | 2.2 |

# b. Linearity/assay reportable range:

# Test Procedure (Dilution Schemes)

According to the NCCLS EP6-P2 protocol, a blood sample of $25~\mathrm{mL}$ was taken, treated with the EDTA in a vacuum tube, and let set for a day. Two glucose concentrations of $10~\mathrm{mL}$ (high and low concentrations) were prepared. As a measuring tool, nine glucose concentrations were prepared using the following dilution schemes (see Table 5).

{5}

Page 6 of 16

Table 5: Levels of Dilution Schemes

| S=9 Samples | |
| --- | --- |
| Level 1(Low, L) | L |
| Level 2 | 0.875L + 0.125H |
| Level 3 | 0.750L + 0.250H |
| Level 4 | 0.625L + 0.375H |
| Level 5 | 0.500L + 0.500H |
| Level 6 | 0.375L + 0.625H |
| Level 7 | 0.250L + 0.750H |
| Level 8 | 0.125L + 0.875H |
| Level 9(High, H) | H |

The meter used in this test can display below $10\mathrm{mg / dL}$ over $600\mathrm{mg / dL}$ for checking linear range.

Each of the glucose levels was measured 5 times to test for precision.

In order to evaluate the straight line for the Sensory Strip that was used, the following formula was used:

$$
1 ^ {\text {s t o r d e r}} \text {p o l y n o m i a l ,} y = a x + b, 2 ^ {\text {n d o r d e r}} \text {p o l y n o m i a l ,} y = a X ^ {2} + b X + c
$$

All dilution schemes start with a high and low concentration samples in which the concentrations meet or exceed the range of interest. For the test, the highest and lowest glucose concentration used was $620\mathrm{mg / dL}$ and $8\mathrm{mg / dL}$. If a strip sensor has an ideal linearity $(r2 = 1)$ from lowest to highest concentration, the ideal concentration of level 2 mixed with $0.875\mathrm{L}$ and $0.125\mathrm{H}$ volume ratio is a $99\mathrm{mg / dL}$ $[(0.875*37.4 + 0.125*530.2) / (0.875 + 0.125)]$.

Table 6, below, shows a summary of the nine dilutions that were measured five times for precision.

{6}

Table 6: Test Result Summary

| Dilution | Rep1 | Rep2 | Rep3 | Rep4 | Rep5 | Mean |
| --- | --- | --- | --- | --- | --- | --- |
| 1 | 1 | 8 | 9 | 8 | 7 | 7 |
| 2 | 2 | 86 | 88 | 84 | 85 | 88 |
| 3 | 3 | 156 | 156 | 156 | 158 | 160 |
| 4 | 4 | 235 | 240 | 238 | 239 | 234 |
| 5 | 5 | 300 | 297 | 295 | 297 | 305 |
| 6 | 6 | 400 | 405 | 407 | 392 | 395 |
| 7 | 7 | 465 | 470 | 470 | 465 | 462 |
| 8 | 8 | 550 | 552 | 554 | 550 | 558 |
| 9 | 9 | 620 | 624 | 615 | 620 | 625 |

The dilution number at Table 6 and Figure 1 represents the Level number at Table 5.

Figure 1: Glucose Linearity Study (Dilution 1-9)

Table 7: The Polynomial Evaluation of Linearity

| Dilution | Actual Mean | Predicted 1st order | Predicted 2nd order | Difference |
| --- | --- | --- | --- | --- |
| 1 | 7.8 | 5.3 | 8.1 | -2.8 |
| 2 | 86.2 | 82.5 | 83.2 | -0.7 |
| 3 | 157.2 | 159.7 | 158.9 | 0.8 |
| 4 | 237.2 | 236.9 | 235.2 | 1.7 |
| 5 | 298.8 | 314.1 | 312.1 | 2.0 |
| 6 | 399.8 | 391.3 | 389.6 | 1.7 |
| 7 | 466.4 | 468.5 | 467.7 | 0.8 |

{7}

Page 8 of 16

| 8 | 552.8 | 545.7 | 546.5 | -0.7 |
| --- | --- | --- | --- | --- |
| 9 | 620.8 | 623.0 | 625.8 | -2.8 |

It has been determined that the polynomial evaluation of linearity assumes that the data set is not linear. This approach assumes that the data points fall perfectly on a line or curve in the absence of random error. The method consists of two parts. The first part examines whether a nonlinear polynomial fits the data better than a linear one. The second part assesses whether the difference between the best-fitting nonlinear and linear polynomial is less than the amount of allowable bias for the method, which should be predefined.

The nonlinear $2^{\mathrm{nd}}$ fits the data better than a linear one, but the difference is lower than $2.0\mathrm{mg / dL}$ from $7.8\mathrm{mg / dL}$ to $620.8\mathrm{mg / dL}$ . The R2 of $1^{\mathrm{st}}$ order regression is a 0.9989.

c. Traceability (controls, calibrators, or method):

CAS# (Chemical Abstract Service)

MDL# (MDL, Inc. Formerly Molecular Design Laboratories)

Glucose # 492615 Sigma Ultra MFCD00063989

Traceability referenced to NBS, NIST Standards

d. Detection limit:

$10 - 600\mathrm{mg / dL}$

1.7 to $33.3\mathrm{mmol / L}$

See linearity study above.

e. Analytical specificity:

Interference testing was conducted to determine the effect of select endogenous and exogenous substances.

## Hematocrit Study

In this study, approximately $2\mathrm{mL}$ of blood was taken from 64 random diabetic individuals. The blood samples were treated with the EDTA vacuum tube and the glucose concentration was adjusted to $< 50 \sim < 580~\mathrm{mg / dL}$ by adding an adequate amount of the phosphate buffer (20mM with pH 7.4) that contains a different level of glucose. In order to adjust the Hematocrit value $(30 \sim 55\%)$ , a proper volume of the centrifuged plasma (serum) was removed.

The Hematocrit level and glucose concentration in the blood was assessed by using the Nova Stat Profile M and the YSI2300 STAT (respectively).

Table 1. Test Result of Blood Glucose Range and Samples:

Result of Blood Glucose and Hematocrit Range

{8}

Page 9 of 16

Figure 1: Blood glucose conc. Vs Hematocrit %

The % bias of the assay value of the FREEDOM™ system is relative to the YSI and does not have a negative or positive correlation to hematocrit level in this experiment. 98% of the data is within +/- 20% bias and 86% lies within +/- 10% in the overall range of glucose and hematocrit.

See Table 1 for summary of interferences tested.

Table 1: Summary of Tested Interferences:

| | Mean of Test Results | | | |
| --- | --- | --- | --- | --- |
| Interferences | High Test Level(mg/dL) | Low (mg/dL) | High (mg/dL) | Error % |
| Acetaminophen | 20 | 98.7 | 100.7 | 2.0 |
| Bilirubin | 40 | 97.3 | 96.0 | -1.4 |
| Gentistic acid | 50 | 114.3 | 140.3 | 22.7 |
| Uric acid | 20 | 92.3 | 86.0 | -6.9 |
| Levo-Dopa | 4 | 98.0 | 109.3 | 11.6 |
| Creatinine | 30 | 119.3 | 126.0 | 5.6 |
| Methyl-Dopa | 2.5 | 105.3 | 113.3 | 7.6 |
| Tolazamide | 5 | 94.0 | 114.3 | 21.6 |
| Dopamine | 13 | 108.3 | 121.3 | 12.0 |
| Ascorbate | 3 | 112.3 | 115.3 | 2.7 |
| EDTA | 640 | 100.0 | 104.3 | 4.3 |

{9}

| Glutathione | 1 | 119.7 | 129.0 | 7.8 |
| --- | --- | --- | --- | --- |
| Heparin | 1,000 | 126.3 | 127.7 | 1.1 |
| Ibuprofen | 40 | 121.3 | 130.7 | 7.7 |
| Salicylic acid | 50 | 135.7 | 137.3 | 1.2 |
| Tetracycline | 0.4 | 126.3 | 129.1 | 2.2 |
| Tolbutamide | 100 | 101.0 | 103.3 | 2.3 |
| Urea | 500 | 112.3 | 113.0 | 0.6 |
| Cholesterol | 500 | 123.0 | 138.7 | 12.7 |
| Triglyceride | 2,890 | 110.7 | 123.3 | 11.4 |

According to the sponsor, the list of interfering substances and their high test level were referenced to NCCLS Document EP7-P.

All low levels $= 0\mathrm{mg / dL}$ except: Urea $= 33~\mathrm{mg / dL}$

Cholesterol $= 209\mathrm{mg / dL}$

Triglyceride $= 210\mathrm{mg / dL}$

It has been determined that reducing substances such as uric acid affect the testing result by falsely increasing values and may activate or deactivate the activity of Glucose Oxidase (GOX), activating GOX makes the test results falsely high.

f. Assay cut-off: Not Applicable

# 2. Comparison studies:

a. Method comparison with predicate device:

The method comparison to the predicate device was assessed with One hundred sixty subjects with Type 1 or Type 2 diabetes during a normally scheduled clinic visits. In the study protocol, both the lay user and a trained technician obtained fingerstick glucose readings on the FREEDOM™ and ONETOUCH ULTRA, as well as alternate site glucose testing on the forearm, part of the hand, upper arm, thigh and calf using both the FREEDOM™, and ONETOUCH ULTRA meters.

The readings were taken as close in time as possible. Within 5 minutes, a venous whole blood was drawn from alternate sites and centrifuged for making serum. The serum sample was tested by Hitachi 747. The sponsor indicated that during the comparison studies, alternate sites were vigorously rubbed by the lay user and trained technician before testing, and in some cases a warming pad was used. It has been suggested that the alternate site -to-finger difference may be minimized by rubbing the site before blood collection.

{10}

Table 1. Summary of test results with finger capillary blood and palm blood obtained by lay users.

| | | Site 1 | Site 2 | Site 3 |
| --- | --- | --- | --- | --- |
| OneTouch (Palm) vs Hithchi747 | Slope: Y-intercept: R: | 0.9788-4.2255 | 0.9877-0.1052 | 0.95209.8344 |
| | Slope: Y-intercept: R: | 0.9851 | 0.9702 | 0.9821 |
| | Slope: Y-intercept: R: | 1.053-4.6727 | 1.0462-4.5411 | 1.0464-5.0969 |
| Freedom (Palm) vs Hithchi747 | Slope: Y-intercept: R: | 0.9772 | 0.9767 | 0.979 |
| Freedom (Capillary) vs Hithchi747 | Slope: Y-intercept: R: | 1.0418-3.2947 | 1.0238-3.7798 | 1.0336-2.2993 |
| Freedom (Palm) vs Freedom (Capillary) | Slope: Y-intercept: R: | 0.9846 | 0.9739 | 0.9844 |
| | Slope: Y-intercept: R: | 1.0059-0.4667 | 0.99514.3643 | 1.0024-0.8446 |
| | Error Grid | Site 1 | Site 2 | Site 3 |
| --- | --- | --- | --- | --- |
| OneTouch (Palm) vs Hithchi747 | A-region | 100% | 98% | 98% |
| | B-region | 0% | 2% | 2% |
| Freedom (Palm) vs Hithchi747 | A-region | 100% | 100% | 98% |
| | B-region | 0% | 0% | 2% |
| Freedom (Capillary) vs Hithchi747 | A-region | 100% | 100% | 98% |
| | B-region | 0% | 0% | 2% |
| Freedom (Palm) vs Freedom (Capillary) | A-region | 100% | 96% | 96% |
| | B-region | 0% | 4% | 4% |

{11}

Table 2. Summary of test results with finger capillary blood and Arm blood obtained by lay users.

| | | Site 1 | Site 2 | Site 3 |
| --- | --- | --- | --- | --- |
| OneTouch (Arm)vs Hithchi747 | Slope: Y-intercept: R: | 1.0291-2.4835 | 0.96045.2987 | 0.99252.4925 |
| | Slope: Y-intercept: R: | 0.9774 | 0.9828 | 0.9639 |
| | Slope: Y-intercept: R: | 0.99470.79370.9909 | 1.00720.02380.9878 | 0.96197.18770.9915 |
| Freedom (Capillary) vs Hithchi747 | Slope: Y-intercept: R: | 0.9753-0.3977 | 0.98090.3006 | 0.96900.8785 |
| | Slope: Y-intercept: R: | 0.9847 | 0.9916 | 0.9940 |
| | Slope: Y-intercept: R: | 1.00523.96370.9776 | 1.01960.91980.9821 | 0.98817.1690.9882 |
| | Error Grid | Site 1 | Site 2 | Site 3 |
| --- | --- | --- | --- | --- |
| OneTouch (Arm) vs Hithchi747 | A-region | 98 % | 98 % | 98 % |
| | B-region | 2 % | 2 % | 2 % |
| Freedom (Arm) vs Hithchi747 | A-region | 100% | 100% | 100% |
| | B-region | 0% | 0% | 0% |
| Freedom (Capillary) vs Hithchi747 | A-region | 100% | 100% | 100% |
| | B-region | 0% | 0% | 0% |
| Freedom (Arm) vs Freedom (Capillary) | A-region | 98 % | 98 % | 100% |
| | B-region | 2 % | 2 % | 0% |

{12}

Table 3. Summary of test results with finger capillary blood and calf, thigh blood obtained by lay users.

| | | Site 1 | Site 2 | Site 3 |
| --- | --- | --- | --- | --- |
| OneTouch (calf and thigh) vs Hithchi747 | Slope: Y-intercept: R: | 0.9942 | 0.9913 | 0.9960 |
| | | 0.5819 | 1.8588 | -0.7162 |
| | | 0.9839 | 0.9893 | 0.9784 |
| Freedom (calf and thigh) vs Hithchi747 | Slope: Y-intercept: R: | 0.9988 | 0.9868 | 0.9792 |
| | | -3.8376 | -2.6589 | 0.4095 |
| | | 0.9788 | 0.9748 | 0.9822 |
| Freedom (Capillary) vs Hithchi747 | Slope: Y-intercept: R: | 1.0224 | 0.9761 | 0.9800 |
| | | -4.7730 | 0.6462 | 3.2339 |
| | | 0.9752 | 0.9831 | 0.9825 |
| Freedom (calf and thigh) vs Freedom (Capillary) | Slope: Y-intercept: R: | 0.9704 | 1.0072 | 0.9931 |
| | | 1.9943 | -2.6566 | -1.6889 |
| | | 0.9904 | 0.9841 | 0.9876 |
| | Error Grid | Site 1 | Site 2 | Site 3 |
| --- | --- | --- | --- | --- |
| OneTouch (calf and thigh) vs Hithchi747 | A-region B-region | 100% 0% | 98% 2% | 98% 2% |
| Freedom (calf and thigh) vs Hithchi747 | A-region B-region | 100% 0% | 100% 0% | 100% 0% |
| Freedom (Capillary) vs Hithchi747 | A-region B-region | 100% 0% | 100% 0% | 100% 0% |
| Freedom (calf and thigh) vs Freedom (Capillary) | A-region B-region | 98% 2% | 100% 0% | 100% 0% |

The comparison test results demonstrated similar results from both meters, with OneTouch at alternate site, Freedom at alternate site, and Freedom at fingerstick capillary according to the slope, Y-intercept, R and error % in Clark Error Grid region. Test results with Freedom at the alternative site of hand versus fingerstick capillary blood, correlation coefficient are 1.0059 ~ 1.053. Test results with Freedom at alternative site of arm versus fingerstick capillary blood, correlation coefficient are

{13}

Page 14 of 16

1.0052 ~ 0.9947. Test results with Freedom at alternative site of leg versus fingerstick capillary blood, correlation coefficient are 0.9704~0.9988. The Freedom Blood Glucose Monitoring System demonstrated equivalence to the OneTouch Ultra predicate device.

## Reference

1. John M. E: Rapid Changes in Postprandial Blood Glucose Produce Concentration Differences at Finger, Forearm, and Thigh Sampling Sites. Diabetes Care 25: 961-964, 2002

b. Matrix comparison: Not Applicable

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):

The accuracy of the FREEDOM™ System was assessed by comparing blood glucose results obtained by patients with those obtained using the Hitachi 747, a laboratory instrument. Glucose levels were measured on 68 and 425 fresh capillary blood specimens by 104 diabetic patients and three healthcare professionals at three different clinical centers.

The correlation between Hitachi 747 and FREEDOM™ were confirmed in the 410 blood samples with the correlation coefficient R=0.9797 and the 104 patients with the correlation coefficient R=0.9782 (Fig. 1 and Fig. 2 respectively). Results indicate that the use of the FREEDOM™ generate results similar to the Hitachi 747.

Figure 1: Linear regression of the 410 blood glucose samples with the Hitachi 747 Vs. FREEDOM™ System at the Clinical Centers.

{14}

Page 15 of 16

# Obtained by Healthcare Professionals in Clinical Centers


Slope 0.9865
y-intercept 0.8342
Correlation coefficient(r) 0.9797
No. of samples 410
Range tested 68-425 mg/dL

Figure 2: Linear regression of the 104 diabetic patients – Hitachi 747 Vs. FREEDOM™ System

# Obtained by Lay diabetics


Slope 0.9974
y-intercept -0.2309
Correlation coefficient(r) 0.9782
No. of samples 104
Range tested 85-430 mg/dL

4. Clinical cut-off: Not Applicable
5. Expected values/Reference range:

The Range of Expected Values was referenced from the Joslin Diabetes Manual.

{15}

Expected blood glucose levels for people without diabetes:

| Time | Range (mg/dL) | Range (mmol/L) |
| --- | --- | --- |
| Before Breakfast: | 70-105 | 3.9-5.8 |
| Before lunch or dinner: | 70-110 | 3.9-6.1 |
| 1 hour after meals: | Less than 160 | Less than 8.9 |
| 2 hours after meals: | Less than 120 | Less than 6.7 |
| Between 2 and 4 AM: | Greater than 70 | Greater than 3.9 |

# N. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10

# O. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.