(244 days)
Not Found
No
The summary describes a standard blood glucose monitoring system using electrochemical technology and does not mention any AI or ML components.
No.
The Intended Use / Indications for Use section states that the system is "an aid to monitor the effectiveness of diabetes control," and "should not be used for the diagnosis of or screening for diabetes." Therapeutic devices are used for treatment or diagnosis, so this device is not therapeutic.
No
The "Intended Use / Indications for Use" section explicitly states: "The GlucoLeader Enhance Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes." While it measures glucose, its purpose is to aid in monitoring effectiveness of diabetes control for those already diagnosed, not to diagnose the condition itself.
No
The device description explicitly states that the system is comprised of a "GlucoLeader Enhance Blood Glucose Meter" and "GlucoLeader Enhance Blood Glucose Test Strips," which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
The intended use explicitly states: "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."
This statement clearly indicates that the device is intended for use outside of the body to examine specimens (blood) from the human body for the purpose of providing information for the diagnosis, monitoring, or treatment of a disease or condition (diabetes). This aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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 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.
Product codes (comma separated list FDA assigned to the subject device)
NBW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertip (for whole blood samples)
Indicated Patient Age Range
Not for use in neonates.
Intended User / Care Setting
Used by a single person for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Altitude study:
- The changes of altitude from sea level to 10,000 feet (3048 meters) appear no significant effect on the glucose measurements.
- Test results show 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%.
- 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.
- Glucose differences are within ±15 mg/dL when glucose concentrations are 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:
- Conducted according to the Guideline of FDA October 11, 2016 Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use.
- Sample size: 100 samples per lot (3 lots).
- Results meet the American Diabetes Association acceptance criteria (CV within 5% at glucose concentration >= 100 mg/dL and SD within 5 mg/dL at glucose concentration = 100 mg/dL, and SD = 100 mg/dL.
- Operating conditions: 50-104 °F (10 ~ 40 °C), 10 ~ 90% RH.
- User performance clinical evaluation:
- Conducted under the directions of Guideline of FDA October 11, 2016 "Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use".
- Sample size: 360 typical users.
- The GlucoLeader Enhance blood glucose meter gave results within 15% of their true blood glucose level 351 out of 360 times.
- System accuracy evaluation at Extreme Glucose Values:
- Measurements from a total of 3 strip lots from 100 subjects.
- More than 95% of individual bias fell within ±15 mg/dL at blood glucose concentration = 75mg/dL.
- Results meet the acceptance criteria.
- Cleaning & disinfection robustness evaluation:
- Tested for 18,250 times of cleanings and disinfections (mimicking 5 years of daily use).
- No damage, readable logo/labels, and proper functionality after testing.
- Shelf life evaluation:
- Unopened vial test strips shelf life: 24 months.
- Opened vial test strips stability: 90 days.
- Unopened vial control solution shelf life: 18 months.
- Opened vial control solution shelf life: 90 days.
- Virucidal efficacy against Hepatitis B surface Antigen (HBsAg):
- Tested by Clorox Germicidal Wipes disinfectant on various device materials (ABS, PMMA, PC, Rubber, PET, PA6T).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Within -run precision evaluation:
- Glucose level 1 (43.2 mg/dL): SD 2.1 mg/dL, CV 4.6%
- Glucose level 2 (80.7 mg/dL): SD 2.9 mg/dL, CV 3.5%
- Glucose level 3 (138.3 mg/dL): SD 4.4 mg/dL, CV 3.3%
- Glucose level 4 (178.5 mg/dL): SD 6.3 mg/dL, CV 3.6%
- Glucose level 5 (278.3 mg/dL): SD 11.1 mg/dL, CV 4.0%
- Intermediate precision (day-to-day) evaluation:
- Glucose level 1 (45.0 mg/dL): SD 1.2 mg/dL, CV 2.8%
- Glucose level 2 (80.0 mg/dL): SD 2.1 mg/dL, CV 2.6%
- Glucose level 3 (125.0 mg/dL): SD 2.7 mg/dL, CV 2.1%
- Glucose level 4 (200.0 mg/dL): SD 3.5 mg/dL, CV 1.7%
- Glucose level 5 (300.0 mg/dL): SD 5.9 mg/dL, CV 1.9%
- User performance clinical evaluation:
- 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 evaluation at Extreme Glucose Values (for glucose concentrations 250 mg/dL):
- Within +/- 5 %: 101/150 (67.3%)
- Within +/- 10 %: 127/150 (84.7%)
- Within +/- 15 %: 146/150 (97.3%)
- Within +/- 20 %: 150/150 (100%)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
2
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)
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."
3
| 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 |
4
● 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,
-
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
5
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
| Items | Predicate device | Subject device |
|---|---|---|
| Manufacturer | HMD BioMedical, Inc. | HMD BioMedical, Inc. |
| Trade Name | GlucoLeader Enhance | |
| Self-Monitoring of Blood Glucose | ||
| System | GlucoLeader Enhance | |
| Blood Glucose Monitoring System | ||
| Product Code | NBW | NBW |
| 510(k) Number | K032985 | K182428 |
| Indications for | ||
| use | The GlucoLeader Enhance | |
| Self-Monitoring of Blood | ||
| Glucose System is intended to be | ||
| used for the quantitative | ||
| measurement of glucose in fresh | ||
| capillary whole blood samples | ||
| drawn from the fingertip as an aid to | ||
| monitor the effectiveness of diabetes | The GlucoLeader Enhance Blood | |
| Glucose Monitoring System is intended | ||
| to be used for the quantitative | ||
| measurement of glucose in fresh | ||
| capillary whole blood samples drawn | ||
| from the fingertip as an aid to monitor | ||
| the effectiveness of diabetes control. | ||
| control. | ||
| Meter differences | ||
| Meter | ||
| Appearance | Image: GlucoLeader meter | Image: GlucoLeader meter |
| LCD screen and | ||
| 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 | ||
| (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 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. | ||
| Meter storage | ||
| environment | 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 memory | |
| mode to recall the information | Same | |
| Set button | stored in meter's memory | |
| Press Set button to enter date and | ||
| time setting | Same | |
| Measuring unit | mg/dL | |
| ( mmol/L) | Same | |
| Resolution | 1 mg/dL LCD display | Same |
| Meter precision | Circuit imprecision CV 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.
10
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 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.
14
. 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)
15
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.