GlucoLeader Enhance Blood Glucose Monitoring System

K182428 · Hmd Biomedical, Inc. · NBW · May 8, 2019 · Clinical Chemistry

Device Facts

• Record ID: K182428
• Device Name: GlucoLeader Enhance Blood Glucose Monitoring System
• Applicant: Hmd Biomedical, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: May 8, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The GlucoLeader Enhance 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 fingertip. The GlucoLeader Enhance Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It 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. The GlucoLeader Enhance Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. GlucoLeader Enhance Blood Glucose Monitoring System is not for use in neonates.

Device Story

System measures glucose in fresh capillary whole blood via fingertip; utilizes amperometric detection with FAD-glucose dehydrogenase (FAD-GDH) enzyme on test strips. User applies blood sample to strip; meter measures resulting electrical current proportional to glucose concentration; converts current to plasma-equivalent glucose value. Device intended for single-patient home use; operated by patient. Meter displays results; aids in monitoring diabetes control effectiveness. Includes error detection for insufficient sample volume, used test strips, and out-of-range environmental conditions (temperature/humidity/altitude). Provides memory for 800 test results. Not for clinical/assisted-use settings due to infection control risks.

Clinical Evidence

Clinical study with 360 lay-user participants performing self-testing. Results compared to YSI 2300 reference method. For glucose < 75 mg/dL, 100% of results were within ± 20 mg/dL. For glucose ≥ 75 mg/dL, 100% of results were within ± 20%. Linear regression: slope 1.0325, R² 0.9791. Bench testing confirmed performance across hematocrit (10-70%), altitude (up to 10,000 ft), and environmental conditions (46.4-111.2°F; 10-90% RH).

Technological Characteristics

Amperometric glucose biosensor; FAD-glucose dehydrogenase (FAD-GDH) chemistry. Measurement range 10-600 mg/dL. Sample volume 0.8 μL. Reaction time 5 seconds. Traceable to NIST SRM 917A. Battery-operated meter; no wireless connectivity. Cleaning/disinfection validated for 18,250 cycles using Clorox Germicidal Wipes.

Indications for Use

Indicated for quantitative measurement of glucose in fresh capillary whole blood from the fingertip for single-person self-testing at home as an aid to monitor diabetes control. Not for diagnosis or screening of diabetes. Not for use in neonates.

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

• Glucoleader Enhance Self-monitoring Of Blood Glucose System (K032985)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 8, 2019

HMD BioMedical Inc. % Ke-Min Jen Chinese-European Industrial Research Society No. 58 Fu-Chiun St. Hsin-Chu City, 30067 Taiwan

Re: K182428

Trade/Device Name: GlucoLeader Enhance Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: March 31, 2019 Received: April 8, 2019

Dear Ke-Min Jen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Kellie B. Kelm, Ph.D. Acting Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) k182428

### Device Name

GlucoLeader Enhance Blood Glucose Monitoring System

Indications for Use (Describe)

The GlucoLeader Enhance Blood Glucose Monitoring System is comprised of GlucoLeader Enhance Blood Glucose Meter and GlucoLeader Enhance Blood Glucose Test Strips.

The GlucoLeader Enhance 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 fingertip. The GlucoLeader Enhance Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is intended for selftesting outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The GlucoLeader Enhance Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. GlucoLeader Enhance Blood Glucose Monitoring System is not for use in neonates.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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| 5. 510(K) Summary of Safety and Effectiveness (Per 21 CFR 807.92) | |
|-------------------------------------------------------------------|------------------------------------------------------------------------------|
| 510(k) number | K182428 |
| Type of 510(k) Submission | Traditional |
| Basis for the submission | A New Device |
| Common Name of the Proposed Device | GLUCOSE TEST SYSTEM |
| Trade name | GlucoLeader Enhance Blood Glucose Monitoring System |
| 510(k) Submitter | HMD BioMedical, Inc. |
| | Address: No. 181, Minsheng St., Xinpu Township, Hsinchu County, Taiwan 30542 |
| | Phone: [phone], Fax: [phone] |
| | Website: www.hmdbio.com |
| Registration Number: | 3003902721 |
| FEI Number: | 3003902721 |
| Date prepared | May 7, 2019 |
| Contact Person | Dr. JEN, KE-MIN |
| | Chinese-European Industrial Research Society |
| | No. 58 Fu-Chiun St., Hsin-Chu City, Taiwan 30067 |
| | TEL: [phone] FAX: [phone] |
| | Email: [e-mail] |
| Classification Regulation | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER (21 CFR 862.1345) |
| Class | II |
| Panel | Clinical Chemistry |
| Product Code | NBW |
| Operator Number | 9053177 |
| Predicate Device | |
| Manufacturer | HMD BioMedical, Inc. |
| Device Name | GlucoLeader Enhance Self-Monitoring of Blood Glucose System |
| 510(k) Number | K032985 |

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#### ● Intended Use:

The GlucoLeader Enhance Blood Glucose Monitoring System is comprised of GlucoLeader Enhance Blood Glucose Meter and GlucoLeader Enhance Blood Glucose Test Strips.

The GlucoLeader Enhance 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 fingertip. The GlucoLeader Enhance Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It 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. The GlucoLeader Enhance Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. GlucoLeader Enhance Blood Glucose Monitoring System is not for use in neonates.

#### ● Device Description:

The GlucoLeader Enhance Blood Glucose Monitoring System is designed to pursuit the accuracy in blood glucose monitoring to provide you with easy and comfortable testing. The GlucoLeader Enhance Blood Glucose Monitoring System mainly consists of four parts as below,

1) GlucoLeader Enhance Blood Glucose Meter

2) GlucoLeader Enhance Blood Glucose Test Strips*

3) GlucoLeader Enhance Glucose Control Solutions (L1-Low glucose level, L2-High glucose level)*

4) GlucoLeader Enhance Check Strip*.

*These products are intended to be used together to get accurate blood glucose test results. They are not included in the kit package, and should be purchased separately.

The meter display screen size of 1.73" x 1.7" is large and easy-to-read, and the meter weight of 0.122 lbs. (55.2 grams) is lightweight and portable for your convenience. The GlucoLeader Enhance Blood Glucose Monitoring System is traceable to the NIST (SRM) 917A. The GlucoLeader Enhance Glucose Control Solutions have L1 and L2 levels for optional purchasing, and L1 is low glucose level and L2 is high glucose level.

The GlucoLeader Enhance Blood Glucose Meter has the latest technology for blood glucose monitoring and is made with quality components. The GlucoLeader Enhance Blood Glucose Test Strips have been updated with Glucose dehydrogenase-FAD Enzyme, which not only improves the accuracy of measurements, but also increases the HCT interference range up to 10-70%. Also, the required test blood sample

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volume is reduced to 0.8 µL, and the test reaction time is only 5 seconds.

If your GlucoLeader Enhance Blood Glucose Meter is being operated by a second person who is providing testing assistance to the user. the meter and lancing device should be disinfected prior to use by the second person. Consult your healthcare professional if unusual readings occur.

#### ● Test Principle

Blood glucose is measured by an electrical current that is produced when a blood sample mixes with the reagent (special chemicals) of the test strip. The electrical current changes with the amount of glucose in the blood sample. The meters measure the strength of the electrical current, calculate your blood glucose level and then display your result in either default unit mg/dL or mmol/L. The GlucoLeader Enhance Blood Glucose Meter, GlucoLeader Enhance Blood Glucose Test Strips and GlucoLeader Enhance Glucose Control Solutions have been designed, tested and proven to work together as a system to produce accurate blood glucose concentration test results.

| Comparison<br>Items | Predicate device | Subject device |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | HMD BioMedical, Inc. | HMD BioMedical, Inc. |
| Trade Name | GlucoLeader Enhance<br>Self-Monitoring of Blood Glucose<br>System | GlucoLeader Enhance<br>Blood Glucose Monitoring System |
| Product Code | NBW | NBW |
| 510(k) Number | K032985 | K182428 |
| Indications for<br>use | The GlucoLeader Enhance<br>Self-Monitoring of Blood<br>Glucose System is intended to be<br>used for the quantitative<br>measurement of glucose in fresh<br>capillary whole blood samples<br>drawn from the fingertip as an aid to<br>monitor the effectiveness of diabetes | The GlucoLeader Enhance Blood<br>Glucose Monitoring System is intended<br>to be used for the quantitative<br>measurement of glucose in fresh<br>capillary whole blood samples drawn<br>from the fingertip as an aid to monitor<br>the effectiveness of diabetes control. |
| control. | | |
| Meter differences | | |
| Meter<br>Appearance | Image: GlucoLeader meter | Image: GlucoLeader meter |
| LCD screen and<br>display size | Image: LCD screen showing 188.8, size: 1.61"(L) x 1.48" (W) | Image: LCD screen showing 88.8, Size: 1.73"(L) x 1.77"(W) |
| Meter dimension<br>(LxWxH) | 3.78" x 2.36" x 0.73" | 3.81" x 2.36"x 0.65" |
| Meter weight<br>(with battery) | 0.154 lbs. (70.0 g) | 0.122 lbs. (55.2g) |
| Reaction time | 15 seconds | 5 seconds |
| Data memory /<br>Recall | Storing 180 test results | Storing 800 test results |
| System operating<br>environment | 50.0 °F -104.0 °F (10 °C-40 °C)<br>20% - 80% R.H. | 46.4 °F -111.2 °F (8 °C-44 °C)<br>10% - 90% R.H. |
| Meter storage<br>environment | 50.0 °F -104.0 °F (10 °C-40 °C)<br>20% - 80% R.H. | -13.0 °F -158.0 °F (-25 °C - 70 °C )<br>10% - 90% R.H. |
| Measuring range | 30 -600 mg/dL<br>(1.66 – 33.3 mmol/L) | 10 - 600 mg/dL<br>(0.6 to 33.3 mmol/L) |
| Meter similarities | | |
| Methodology | Amperometry glucose biosensor | Same |
| Memory button | Press Mem button to enter memory<br>mode to recall the information | Same |
| | | |
| Set button | stored in meter's memory<br>Press Set button to enter date and<br>time setting | Same |
| Measuring unit | mg/dL<br>( mmol/L) | Same |
| Resolution | 1 mg/dL LCD display | Same |
| Meter precision | Circuit imprecision CV < 5% | Same |
| Meter electrical accuracy | Tested with standard resistor the<br>bias < ±2% | Same |
| Code-checking mechanism | Code number checking | Same |
| Temperature compensation mechanism | Automatic compensation with<br>built-in thermistor | Same |
| Power source | One Lithium battery ( 3V, CR2032) | Same |
| Power saving | Automatic shut-off in 3-minute idle | Same |
| Battery operation life | More than 1000 times test | Same |
| Strip Differences | | |
| Test strips appearance | Image: Test strip 1<br>Dimensions: 1.46"X 0.24" x 0.02" | Image: Test strip 2<br>Different Appearance but has the same<br>dimensions |
| Enzyme | Glucose Oxidase (GOD) | Glucose Dehydrogenase-FAD<br>(GDH-FAD) |
| Minimum sample volume | 3.0 µL | 0.8 µL |
| HCT range | 30 - 50% | 10 - 70% |
| System operating environment | 50.0 °F~104.0 °F (10°C~40°C),<br>20% ~ 80% R.H. | 46.4 °F~111.2 °F (8 °C~44 °C),<br>10% - 90% R.H. |
| Strip Storage Environment | 50.0 °F~104.0 °F (10 °C~40 °C),<br>20%~80% R.H. | 35.6 °F~ 86.0 °F (2°C~30°C),<br>10% - 90% R.H. |
| Reaction time | 15 seconds | 5 seconds |
| Strip similarities | | |
| Methodology | Amperometry glucose biosensor | Same |
| Type of blood drawing | Two sides | Same |
| Strip precision | Imprecision CV < 5% | Same |
| Strip dimension | 1.46"X 0.24" x 0.02" | Same |
| Specimen | Capillary whole blood from fingertip | Same |
| | | |
| Shelf life | 24 months for closed vial of test strips<br>90 days after first opening cap of test strips vial | Same |
| Compliant<br>Electrical Safety<br>& EMC<br>standards | EMC:<br>EN 60601-1-2:2007+AC:2010<br>IEC 61326-1:2006<br>IEC 61326-2-6:2005<br><br>Electrical Safety:<br>EN 61010-1:2001<br>EN 61010-2-101:2002 | EMC:<br>IEC 60601-1-2:2007*<br>IEC 61326-1:2012<br>IEC 61326-2-6:2012<br>47 CFR FCC Part 15 Subpart B<br><br>Electrical Safety:<br>IEC 61010-1:2010**<br>IEC 61010-2-101:2015 |
| | | *It is recognized by FDA as 19-1.<br>**It is recognized by FDA as19-18. |

#### ● Comparison Table

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# HMD Your Partner in Blood Glucose Monitoring

HMD BioMedical, Inc. http:// www.hmdbio.com No.181, Mingsheng Street, Xinpu Township, Hsinchu 30542, Taiwan
Tel: [phone] Fax: [phone]

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# HMD Your Partner in Blood Glucose Monitoring

HMD BioMedical, Inc. http:// www.hmdbio.com No.181, Mingsheng Street, Xinpu Township, Hsinchu 30542, Taiwan Tel: [phone] Fax: [phone]

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# our Partner in Blood Glucose Monitoring HMD BioMedical, Inc. http:// www.hmdbio.com

No.181, Mingsheng Street, Xinpu Township, Hsinchu 30542, Taiwan Tel: [phone] Fax: [phone]

#### ● Substantial Equivalence Discussions

A claim of substantial equivalence is made to GlucoLeader Enhance Self-Monitoring of Blood Glucose System (k032985). Both of them have the similar indications for use, the same working principle, technologies and detection method. The minor differences for the two devices are LCD screen size, meter dimensions, meter weight, reaction time, data memory, meter storage environment, measuring range, enzyme, minimum sample volume, strip accuracy, HCT range, system operating environment, and strip storage environment,

The GlucoLeader Enhance Blood Glucose Test Strips have been updated with Glucose Dehydrogenase-FAD Enzyme, which not only improves the accuracy to the standard, but also increases the HCT interference range up to 10-70%. The test required blood sample volume reduced to 0.8 µL, and the test reaction time is only 5 seconds

Most of these differences have been validated through the respective non-clinical and clinical testing to indicate there are no any new safety and effectiveness concerns raised. Besides, the subject device and predicate device have the similar intended for use in the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingers. Thus the differences are shown to be due to the feature design aspects, not to raise any new safety or effectiveness concerns.

The conclusions drawn from the non-clinical and clinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device identified in the submission. Thus the subject device is substantially equivalent to the predicate devices.

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#### ● Summary of performance tests

#### ■ Altitude study:

The changes of altitude from sea level to 10,000 feet (3048 meters) appear no significant effect on the glucose measurements of the GlucoLeader Enhance Blood Glucose Monitoring System. The test results of one lot of test strip show that bias and bias% of five glucose measures at each attitude level are within the acceptance criteria of the glucose difference within ±10 %.

#### . Hematocrit interference study:

GlucoLeader Enhance Blood Glucose Monitoring System is capable of precise measurement with 5 intervals of blood glucose concentrations and with hematocrit range from 10% to 70%. The Glucose differences are within ±8% and no individual value differences ±15% relative to the YSI, at HCT levels from 10% to 70% when glucose concentrations are □ 75 mg/dL. The Glucose differences are within ±15 mg/dL when glucose concentrations are < 75mg/dL. The test results of hematocrit effect are verdict "Accept" at HCT levels from 10% to 70%.

#### 1 Interference substances evaluation:

This evaluation was conducted under the directions of Guideline of FDA October 11, 2016 "Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use" and CLSI EP7-A2. According to this study, evaluating 26 endogenous and exogenous substances in venous blood samples with 3 different levels of glucose concentrations, split into a control sample and a test sample. The % difference between the test and control sample was calculated. The highest concentration tested at which no significant interference was summarized as below.

A sample with large amount of reducing substances such as Acetaminophen (>5mg/dL), Unconjugated Bilirubin (>20mg/dL), Conjugated Bilirubin (>25mg/dL), Dopamine (>2.5mg/dL), Gentisic acid (>1.875mg/dL), Reduced Glutathione (>23mg/dL), Hemoglobin (>2500mg/dL), Maltose (>625mg/dL), Methyldopa (>3.13mg/dL), Sodium (>610mg/dL), Tolazamide (>4.7mg/dL), Triglycerides (>750mg/dL), Uric acid (>12mg/dL) may cause the result slightly higher than the actual glucose level.

#### . Within -run precision evaluation:

The evaluation was conducted according to the Guideline of FDA October 11, 2016 Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use.

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# Your Partner in Blood Glucose Monitoring

HMD BioMedical, Inc. http:// www.hmdbio.com No.181, Mingsheng Street, Xinpu Township, Hsinchu 30542, Taiwan Tel: [phone] Fax: [phone]

The within-run precision evaluation results of GlucoLeader Enhance Blood Glucose Monitoring System meet the American Diabetes Association acceptance criteria, i.e., CV within 5% at glucose concentration □ 100 mg/dL and SD within 5 mg/dL at glucose concentration < 100 mg/dL. The summary table of within-run precision test by Lot 1 for 100 samples is shown as below. The test results meet the acceptance criteria and GlucoLeader Enhance Blood Glucose Monitoring System passes the within-run precision evaluation.

| Glucose<br>level | Lot | Standard YSI<br>Glucose concentration (mg/dL) | SD<br>(mg/dL) | CV% |
|------------------|----------|-----------------------------------------------|---------------|------|
| 1 | 1 | 43.2 | 1.8 | 4.2% |
| | 2 | | 2.4 | 5.0% |
| | 3 | | 2.0 | 4.2% |
| | Combined | | 2.1 | 4.6% |
| 2 | 1 | 80.7 | 2.8 | 3.4% |
| | 2 | | 3.5 | 4.1% |
| | 3 | | 2.2 | 2.6% |
| | Combined | | 2.9 | 3.5% |
| 3 | 1 | 138.3 | 4.1 | 3.2% |
| | 2 | | 4.9 | 3.8% |
| | 3 | | 4.0 | 3.0% |
| | Combined | | 4.4 | 3.3% |
| 4 | 1 | 178.5 | 6.2 | 3.6% |
| | 2 | | 6.4 | 3.7% |
| | 3 | | 6.2 | 3.6% |
| | Combined | | 6.3 | 3.6% |
| 5 | 1 | 278.3 | 11.3 | 4.1% |
| | 2 | | 11.6 | 4.2% |
| | 3 | | 10.4 | 3.8% |
| | Combined | | 11.1 | 4.0% |

## Data Summary of the within-run precision test results

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#### . Intermediate precision (day-to-day) evaluation

The Intermediate (day-to-day) precision evaluation results of GlucoLeader Enhance Blood Glucose Monitoring System are shown in the following table. The criteria is the CV of the glucose devices must be less than 5 % when the concentration is □ 100 mg/dL, and SD must be less than 5 mg/dL when the concentration is <100 mg/dL. Compared to the criteria, it is concluded that the subject device passes the intermediate precision evaluation.

| Glucose<br>level | Lot | Standard YSI glucose<br>concentration (mg/dL) | SD (mg/dL) | CV% |
|------------------|----------|-----------------------------------------------|------------|-----|
| 1 | 1 | 45.0 | 1.1 | 2.6 |
| | 2 | | 1.2 | 2.7 |
| | 3 | | 1.4 | 3.2 |
| | Combined | | 1.2 | 2.8 |
| 2 | 1 | 80.0 | 1.7 | 2.2 |
| | 2 | | 1.7 | 2.2 |
| | 3 | | 2.7 | 3.3 |
| | Combined | | 2.1 | 2.6 |
| 3 | 1 | 125.0 | 2.7 | 2.0 |
| | 2 | | 2.8 | 2.2 |
| | 3 | | 2.6 | 2.0 |
| | Combined | | 2.7 | 2.1 |
| 4 | 1 | 200.0 | 3.2 | 1.6 |
| | 2 | | 3.6 | 1.8 |
| | 3 | | 3.7 | 1.8 |
| | Combined | | 3.5 | 1.7 |
| 5 | 1 | 300.0 | 5.3 | 1.8 |
| | 2 | | 5.6 | 1.9 |
| | 3 | | 6.7 | 2.2 |
| | Combined | | 5.9 | 1.9 |

Data Summary of the intermediate precision results

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#### . Linearity evaluation:

Linearity evaluation are conducted under the directions of CLSI EP6-A, and the results show the correlation coefficient is 1.00. The linearity range of GlucoLeader Enhance Blood Glucose Monitoring System is 10 - 600 mg/dL.

#### ■ Sample perturbation study:

Sample perturbation occurs when a user has applied an appropriate volume of blood to the test strip for glucose measurement but an event such as wicking of blood away from the test strip, flicking of the test strip or flicking of the meter occurs during the start of measurement. Under the directions of FDA Guideline of October 11, 2016 "Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use" and CLSI EP7-A2, the results show the sampling perturbation has no significant effect on precise blood glucose measurement for GlucoLeader Enhance Blood Glucose Monitoring System.

#### . Sample volume evaluation:

Under the directions CLSI EP7-A2 and Guideline of FDA October 11, 2016 "Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use" and CLSI EP7-A2, it is shown the sample volume of 0.8 µL is the minimum sample volume to have accurate measurements. When the blood sample volume is less than 0.8uL reaction chamber of the test strip cannot be fully filled and the measurement will not start. The meter will automatically display the error code number E42.

#### 1 Stressed operating temperature and humidity evaluation:

The stressed operating temperature and humidity evaluation results show the Bias are less than 10 mg/dL for glucose <100 mg/dL and Bias are less than 10 % for glucose □ 100 mg/dL. The test results meet the acceptance criteria. We declare that the GlucoLeader Enhance Blood Glucose Monitoring System can be operated normally under the conditions of 50-104 °F (10 ~ 40 °C), 10 ~ 90% RH.

#### . User performance clinical evaluation:

This User performance evaluation was conducted under the directions of Guideline of FDA October 11, 2016 "Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use". The results of a study where 360 typical users used the GlucoLeader Enhance blood glucose meter to test their blood glucose level. The GlucoLeader Enhance blood glucose meter gave results within 15% of their true blood glucose level 351 out of 360 times. The summary of data

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for measurements performed by Lot 1 versus YSI 2300 shown below meets the acceptance criteria.

| Within±5% | Within±10% | Within±15% | Within±20% |
|-----------------|-----------------|-----------------|----------------|
| 59.7% (215/360) | 84.7% (305/360) | 97.5% (351/360) | 100% (360/360) |

#### . System accuracy evaluation at Extreme Glucose Values:

According to the results from the measurements of a total of 3 strip lots from 100 subjects at extreme glucose values, more than 95% of individual bias fell within ±15 mg/dL at blood glucose concentration < 75 mg/dL and more than 95% of individual bias fell within ±15% at blood glucose concentrations ≥75mg/dL. Therefore, the results meet the acceptance criteria.

Summary of data within mg/dL of the comparator method for glucose concentrations < 80 mg/dL: (All Lots)

| Within +/- 5 mg/dL | Within +/- 10 mg/dL | Within +/- 15 mg/dL | Within +/- 20 mg/dL |
|--------------------|---------------------|---------------------|---------------------|
| 97/150 (64.7%) | 140/150 (93.3%) | 148/150 (98.7%) | 150/150 (100%) |

Summary of data within % of the comparator method for glucose concentrations > 250 mg/dI : (All Lots)

| Within +/- 5 % | Within +/- 10 % | Within +/- 15 % | Within +/- 20 % |
|-----------------|-----------------|-----------------|-----------------|
| 101/150 (67.3%) | 127/150 (84.7%) | 146/150 (97.3%) | 150/150 (100%) |

#### . Cleaning & disinfection robustness evaluation:

The physical appearance and performance checks on the GlucoLeader Enhance Blood Glucose Meters and lancing devices were capable for 18,250 times of cleanings and disinfections, which mimicked the regular use of a lay-user who used 10 times a day for 5 years. After 18,250 times of cleanings and disinfections, with no damaging and readable logo/labels on the GlucoLeader Enhance Blood Glucose meters and lancing devices. The performances of the GlucoLeader Enhance Blood Glucose meters and lancing devices worked properly with the stimulated test strip. These results concluded that with 5 years of regular uses for 10 times a day, i.e., 18,250 times of cleanings and disinfections, the appearance, performance, reading, and functionalities of the GlucoLeader Enhance Blood Glucose meters and lancing devices would not be affected.

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#### . User performance clinical evaluation:

This User performance evaluation was conducted under the directions of Guideline of FDA October 11, 2016 "Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use". The results of a study where 360 typical users used the GlucoLeader Enhance blood glucose meter to test their blood glucose level. The GlucoLeader Enhance blood glucose meter gave results within 15% of their true blood glucose level 351 out of 360 times. The summary of data for measurements performed by Lot 1 versus YSI 2300 shown below meets the acceptance criteria.

| Within±5% | Within±10% | Within±15% | Within±20% |
|-----------------|-----------------|-----------------|----------------|
| 59.7% (215/360) | 84.7% (305/360) | 97.5% (351/360) | 100% (360/360) |

#### 1 Shelf life evaluation:

- · Test strips unopened vial shelf life study: The shelf life of the unopened vial of Test Strips is validated and claimed to be 24 months.
- · Test strips opened vial stability study: The shelf life of the Test Strips opened vial is claimed to be 90 days.
- Control solution unopened vial shelf life stability study: The shelf life of the unopened vial of GlucoLeader Enhance Glucose Control Solutions is validated and claimed to be 18 months.
- · Control solutions opened vial shelf life stability study: The shelf life of the opened vial of Control Solutions is claimed to be 90 days.
- . Virucidal efficacy against Hepatitis B surface Antigen (HBsAg) by the Clorox Germicidal Wipes disinfectant,
- On main housing materials of ABS (white & blue)
- On test slot of PMMA (transparent(0
- On LCD display lens of PC (transparent)
- On Mem and Set buttons of Rubber (black)
- On label surface layer of PET (transparent)
- On data port of Polyamide 6T (PA6T) (black)

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Image /page/15/Picture/0 description: The image contains the logo and contact information for HMD BioMedical. The logo features the company's name in a stylized hexagon shape. The text includes the company's slogan, "Your Partner in Blood Glucose Monitoring," as well as their website, address, telephone number, and fax number. The address is No.181, Mingsheng Street, Xinpu Township, Hsinchu 30542, Taiwan, and the phone and fax numbers are [phone] and [phone], respectively.

#### ● Conclusions

The conclusions drawn from the non-clinical & clinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device identified in the submission. Thus the subject device is substantially equivalent to the predicate devices.