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.

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,

GlucoLeader Enhance Blood Glucose Meter
GlucoLeader Enhance Blood Glucose Test Strips*
GlucoLeader Enhance Glucose Control Solutions (L1-Low glucose level, L2-High glucose level)*
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 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.

AI/ML Overview

The GlucocLeader Enhance Blood Glucose Monitoring System is a medical device for quantitative measurement of glucose in fresh capillary whole blood samples. It is intended for self-testing by people with diabetes at home.

Here's an analysis of its acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance

Test Type	Acceptance Criteria	Reported Device Performance
Accuracy (User Performance)	"The GlucoLeader Enhance blood glucose meter gave results within 15% of their true blood glucose level 351 out of 360 times." (This implies a requirement for at least 97.5% of readings to be within ±15%.)	Within ±5%: 59.7% (215/360) Within ±10%: 84.7% (305/360) Within ±15%: 97.5% (351/360) Within ±20%: 100% (360/360)
System Accuracy at Extreme Glucose Values (< 75 mg/dL)	More than 95% of individual bias fell within ±15 mg/dL.	Within ±5 mg/dL: 64.7% (97/150) Within ±10 mg/dL: 93.3% (140/150) Within ±15 mg/dL: 98.7% (148/150) Within ±20 mg/dL: 100% (150/150) (All Lots combined for glucose concentrations < 80 mg/dL, which is slightly different but still relevant.)
System Accuracy at Extreme Glucose Values (≥ 75 mg/dL)	More than 95% of individual bias fell within ±15%.	Within ±5%: 67.3% (101/150) Within ±10%: 84.7% (127/150) Within ±15%: 97.3% (146/150) Within ±20%: 100% (150/150) (All Lots combined for glucose concentrations > 250 mg/dL, which represents a high glucose extreme, not necessarily the entire range ≥ 75 mg/dL, but confirms performance at high values.)
Within-Run Precision	CV within 5% at glucose concentration ≥ 100 mg/dL, and SD within 5 mg/dL at glucose concentration < 100 mg/dL (American Diabetes Association acceptance criteria).	Glucose Level 1 (43.2 mg/dL): Combined SD 2.1 mg/dL (meets < 5 mg/dL) Glucose Level 2 (80.7 mg/dL): Combined SD 2.9 mg/dL (meets < 5 mg/dL) Glucose Level 3 (138.3 mg/dL): Combined CV 3.3% (meets < 5%) Glucose Level 4 (178.5 mg/dL): Combined CV 3.6% (meets < 5%) Glucose Level 5 (278.3 mg/dL): Combined CV 4.0% (meets < 5%)
Intermediate Precision (Day-to-Day)	CV of glucose devices < 5% when concentration ≥ 100 mg/dL, and SD < 5 mg/dL when concentration < 100 mg/dL.	Glucose Level 1 (45.0 mg/dL): Combined SD 1.2 mg/dL (meets < 5 mg/dL) Glucose Level 2 (80.0 mg/dL): Combined SD 2.1 mg/dL (meets < 5 mg/dL) Glucose Level 3 (125.0 mg/dL): Combined CV 2.1% (meets < 5%) Glucose Level 4 (200.0 mg/dL): Combined CV 1.7% (meets < 5%) Glucose Level 5 (300.0 mg/dL): Combined CV 1.9% (meets < 5%)
Hematocrit Interference	Glucose differences 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. Glucose differences within ±15 mg/dL when glucose concentrations are < 75 mg/dL.	Verdict "Accept" for HCT levels from 10% to 70%.
Altitude Study	Bias and bias% of five glucose measures at each altitude level (sea level to 10,000 feet) within ±10 %.	No significant effect on glucose measurements; bias and bias% within acceptance criteria.
Linearity	Not explicitly stated, but the result should demonstrate linear correlation.	Correlation coefficient is 1.00. Linearity range is 10 - 600 mg/dL.
Stressed Operating Temperature and Humidity	Bias < 10 mg/dL for glucose < 100 mg/dL and Bias < 10 % for glucose ≥ 100 mg/dL. Operating conditions: 50-104 °F (10 ~ 40 °C), 10 ~ 90% RH.	Test results meet acceptance criteria. The system can be operated normally under 50-104 °F (10 ~ 40 °C), 10 ~ 90% RH.
Cleaning & Disinfection Robustness	Capable for 18,250 times of cleanings and disinfections (mimicking 10 times/day for 5 years), with no damaging and readable logo/labels, and proper performance/functionality.	Device capable for 18,250 times; no damage, readable logo/labels, and worked properly with stimulated test strip.
Sample Perturbation Study	(Implicitly that perturbation should not significantly affect precise blood glucose measurement).	No significant effect on precise blood glucose measurement.
Sample Volume Evaluation	(Implicitly that the device should indicate an error if insufficient sample volume, and perform accurately with sufficient volume). Minimum sample volume of 0.8 µL for accurate measurements.	0.8 µL is the minimum; if less, error code E42 is displayed.
Interference Substances Evaluation	(Implicitly, the device should perform accurately in the presence of common interfering substances up to specified concentrations).	Highest concentration tested at which no significant interference was summarized. Some substances (e.g., Acetaminophen, high bilirubin, hemoglobin, maltose, triglycerides) may cause slightly higher results at high concentrations.
Shelf Life (Test Strips - Unopened Vial)	24 months	Validated and claimed to be 24 months.
Shelf Life (Test Strips - Opened Vial)	90 days	Claimed to be 90 days.
Shelf Life (Control Solution - Unopened Vial)	18 months	Validated and claimed to be 18 months.
Shelf Life (Control Solution - Opened Vial)	90 days	Claimed to be 90 days.

2. Sample Sizes and Data Provenance

User Performance Clinical Evaluation:
- Test Set Sample Size: 360 typical users.
- Data Provenance: The document does not specify the country of origin, but the submitting company is HMD BioMedical Inc. based in Taiwan. The study is described as a "User performance evaluation" and "clinical evaluation," implying prospective data collection with human participants.
System Accuracy Evaluation at Extreme Glucose Values:
- Test Set Sample Size: 100 subjects.
- Data Provenance: The document does not specify the country of origin. This also appears to be prospectively collected clinical data from human subjects.
Within-run precision evaluation: 100 samples (for Lot 1, and presumably for Lots 2 and 3 as well, making it 300 samples total across lots). Data provenance is not specified beyond being laboratory-generated.
Intermediate precision (day-to-day) evaluation: Number of samples not explicitly stated per lot, but given the structure, it likely involves multiple measurements over several days across different glucose levels and lots. Data provenance is not specified beyond being laboratory-generated.
Other studies (Altitude, Hematocrit, Interference, etc.): Sample sizes are generally not explicitly quantified beyond statements like "five glucose measures at each attitude level" or "3 different levels of glucose concentrations" with "26 endogenous and exogenous substances." These are typically laboratory-based tests.

3. Number of Experts and Qualifications for Ground Truth

No information provided: The document does not mention the number of experts or their qualifications used to establish ground truth for any of the studies.
Implied Standard Reference Method: The ground truth for glucose measurements (e.g., in user performance and system accuracy studies) is consistently compared against a "YSI 2300." The YSI 2300 STAT Plus Glucose & Lactate Analyzer is a laboratory reference method widely accepted for accurate glucose measurement. This suggests that the ground truth is established by a highly accurate laboratory instrument, not human experts in the traditional sense of image interpretation.

4. Adjudication Method for the Test Set

None applicable: For glucose monitoring systems, ground truth is established by a reference laboratory instrument (YSI 2300). There is no "adjudication" between human readers or experts as there would be for image interpretation tasks. The comparison is directly between the device's reading and the YSI's reading.

5. MRMC Comparative Effectiveness Study

Not Applicable: This type of study (Multi-Reader Multi-Case comparative effectiveness, assessing human reader improvement with/without AI assistance) is typically relevant for interpretative medical tasks (e.g., radiology AI). The GlucoLeader Enhance is a direct measurement device, not an AI or interpretive tool that assists human readers. Therefore, no such study was conducted or is relevant.

6. Standalone Performance

Yes, standalone performance was done: All listed performance studies (User performance, System Accuracy, Precision, Linearity, Hematocrit, Interference, etc.) evaluate the algorithm/device's performance directly against a reference method (YSI 2300) without human intervention in the measurement interpretation itself. The "User performance clinical evaluation" assesses how typical users operate the device and obtain results, but the accuracy assessment is still the device's output versus the reference.

7. Type of Ground Truth Used

Reference Laboratory Method / Expert Instrument: The ground truth for glucose concentration measurements is established using the YSI 2300 (likely the YSI 2300 STAT Plus Glucose & Lactate Analyzer), which is a highly accurate and widely accepted laboratory reference instrument for glucose measurement. This falls under the category of a "reference standard" or "expert instrument" rather than direct human expert consensus or pathology data.

8. Sample Size for the Training Set

Not applicable / Not explicitly stated: For a traditional medical device like a blood glucose monitor, there isn't typically a "training set" in the machine learning sense. The device's performance is based on its electrochemical methodology and calibration, not on a machine learning model trained on a dataset. The document does not provide details on development or calibration data, which might be analogous to a training set for machine learning devices, but it's not discussed in those terms.

9. How the Ground Truth for the Training Set Was Established

Not applicable: As explained above, for this type of device, a "training set" in the machine learning context is not relevant. The device is calibrated during manufacturing using reference standards, but detailed procedures for this are not part of the regulatory submission about performance testing.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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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: 886-3-5895000, Fax: 886-3-5885500
	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: 886-3-5208829 FAX: 886-3-5209783
	Email: ceirs.jen@msa.hinet.net
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:

GlucoLeader Enhance Blood Glucose Meter
GlucoLeader Enhance Blood Glucose Test Strips*
GlucoLeader Enhance Glucose Control Solutions (L1-Low glucose level, L2-High glucose level)*
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.

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

● 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.

ComparisonItems	Predicate device	Subject device
Manufacturer	HMD BioMedical, Inc.	HMD BioMedical, Inc.
Trade Name	GlucoLeader EnhanceSelf-Monitoring of Blood GlucoseSystem	GlucoLeader EnhanceBlood Glucose Monitoring System
Product Code	NBW	NBW
510(k) Number	K032985	K182428
Indications foruse	The GlucoLeader EnhanceSelf-Monitoring of BloodGlucose System is intended to beused for the quantitativemeasurement of glucose in freshcapillary whole blood samplesdrawn from the fingertip as an aid tomonitor the effectiveness of diabetes	The GlucoLeader Enhance BloodGlucose Monitoring System is intendedto be used for the quantitativemeasurement of glucose in freshcapillary whole blood samples drawnfrom the fingertip as an aid to monitorthe effectiveness of diabetes control.
control.
Meter differences
MeterAppearance	Image: GlucoLeader meter	Image: GlucoLeader meter
LCD screen anddisplay 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(LxWxH)	3.78" x 2.36" x 0.73"	3.81" x 2.36"x 0.65"
Meter weight(with battery)	0.154 lbs. (70.0 g)	0.122 lbs. (55.2g)
Reaction time	15 seconds	5 seconds
Data memory /Recall	Storing 180 test results	Storing 800 test results
System operatingenvironment	50.0 °F -104.0 °F (10 °C-40 °C)20% - 80% R.H.	46.4 °F -111.2 °F (8 °C-44 °C)10% - 90% R.H.
Meter storageenvironment	50.0 °F -104.0 °F (10 °C-40 °C)20% - 80% R.H.	-13.0 °F -158.0 °F (-25 °C - 70 °C )10% - 90% R.H.
Measuring range	30 -600 mg/dL(1.66 – 33.3 mmol/L)	10 - 600 mg/dL(0.6 to 33.3 mmol/L)
Meter similarities
Methodology	Amperometry glucose biosensor	Same
Memory button	Press Mem button to enter memorymode to recall the information	Same

Set button	stored in meter's memoryPress Set button to enter date andtime setting	Same
Measuring unit	mg/dL( mmol/L)	Same
Resolution	1 mg/dL LCD display	Same
Meter precision	Circuit imprecision CV < 5%	Same
Meter electrical accuracy	Tested with standard resistor thebias < ±2%	Same
Code-checking mechanism	Code number checking	Same
Temperature compensation mechanism	Automatic compensation withbuilt-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 1Dimensions: 1.46"X 0.24" x 0.02"	Image: Test strip 2Different Appearance but has the samedimensions
Enzyme	Glucose Oxidase (GOD)	Glucose Dehydrogenase-FAD(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),20% ~ 80% R.H.	46.4 °F~~111.2 °F (8 °C~~44 °C),10% - 90% R.H.
Strip Storage Environment	50.0 °F~~104.0 °F (10 °C~~40 °C),20%~80% R.H.	35.6 °F~ 86.0 °F (2°C~30°C),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 strips90 days after first opening cap of test strips vial	Same
CompliantElectrical Safety& EMCstandards	EMC:EN 60601-1-2:2007+AC:2010IEC 61326-1:2006IEC 61326-2-6:2005Electrical Safety:EN 61010-1:2001EN 61010-2-101:2002	EMC:IEC 60601-1-2:2007IEC 61326-1:2012IEC 61326-2-6:201247 CFR FCC Part 15 Subpart BElectrical Safety:IEC 61010-1:2010*IEC 61010-2-101:2015
		It is recognized by FDA as 19-1.*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: +886-3-589-5000 Fax: +886-3-588-5500

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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: +886-3-589-5000 Fax: +886-3-588-5500

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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: +886-3-589-5000 Fax: +886-3-588-5500

● 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: +886-3-589-5000 Fax: +886-3-588-5500

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.

Glucoselevel	Lot	Standard YSIGlucose concentration (mg/dL)	SD(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.

Glucoselevel	Lot	Standard YSI glucoseconcentration (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:

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 +886-3-589-5000 and +886-3-588-5500, 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.

Regulation Number and Section

§ 862.1345 Glucose test system.

(a)
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.(b)
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.