(406 days)
No
The document describes a standard blood glucose monitoring system based on enzymatic reaction and electrochemical measurement, with no mention of AI or ML in the intended use, device description, or performance studies.
No.
This device is an in vitro diagnostic device intended for monitoring blood glucose levels, not for treating any condition.
Yes
The device is intended for the quantitative measurement of glucose in blood samples, which is used to monitor the effectiveness of diabetes control. The "Intended Use / Indications for Use" section explicitly states it is for "in vitro diagnostic use" and aids in monitoring, which falls under the definition of a diagnostic device. While it states it should not be used for "diagnosis of or screening for diabetes," its role in monitoring a disease condition indicates it serves a diagnostic purpose.
No
The device description explicitly states that the system is comprised of a "GlucoLeader Enhance 2 Blood Glucose Meter" and "GlucoLeader Enhance 2 Blood Glucose Test Strips," which are physical hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home (over the counter [OTC]) as an aid to monitor the effectiveness of diabetes control."
This statement clearly identifies the device as being used for testing biological samples (blood) outside of the body to provide information about a health condition (diabetes control), which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The GlucoLeader Enhance 2 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 2 Blood Glucose Monitoring System is comprised of the GlucoLeader Enhance 2 Blood Glucose Meter and the GlucoLeader Enhance 2 Blood Glucose Test Strips. The GlucoLeader Enhance 2 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 (over the counter [OTC]) as an aid to monitor the effectiveness of diabetes control. The GlucoLeader Enhance 2 Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. GlucoLeader Enhance 2 Blood Glucose Monitoring System is not for use in neonates.
Product codes
NBW
Device Description
The GlucoLeader Enhance 2 Blood Glucose Monitoring System is designed to pursuit the accuracy in blood glucose monitoring to provide with testing. The GlucoLeader Enhance 2 Blood Glucose Monitoring System mainly consists of four parts as below,
- (1) GlucoLeader Enhance 2 Blood Glucose Meter
- GlucoLeader Enhance 2 Blood Glucose Test Strips* (2)
- Glucose Control Solutions (L1, L2)* (3)
- (4) 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.
Display screen size of the meter is 1.73" x 1.7", and weight of the meter is 0.122 lbs (55.2 grams). The GlucoLeader Enhance 2 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.
The GlucoLeader Enhance 2 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 uL, and the test reaction time is only 5 seconds.
If the GlucoLeader Enhance 2 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.
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip
Indicated Patient Age Range
not for use in neonates.
Intended User / Care Setting
self-testing outside the body (in vitro diagnostic use) by people with diabetes at home (over the counter [OTC])
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)
Non-clinical Testing:
The GlucoLeader Enhance 2 has been compared with "GlucoLeader Enhance (K182428)". The subject device has same intended use, principle of operation as the predicate device. The design control process and validation tests were completed to confirm the safety and performance of the subject device.
Changes:
- The color of the meter appearance changed from blue to green.
- Rename the test strip which is dedicated to Enhance 2 system.
- Add the Bluetooth function to the meter, changes including PCB layout, firmware for BLE pairing and transmission, and wireless communication.
Validation activities:
- Software validation and wireless security, including SweynTooth vulnerabilities and cybersecurity evaluation, complied with Guidance on software validation, wireless technology and cybersecurity.
- Electromagnetic compatibility (EMC), conducted and complied with IEC 60601-1-2.
Results:
After testing, it guarantees the security of data transmission will not be interfered by other products with BLE, and can transmit multiple data at the same time. All data are correct, and they prove the reliability and accuracy of the GlucoLeader Enhance 2.
Clinical Testing:
No new clinical test data was used to support the decision of substantial equivalence.
Key results: The new version of the GlucoLeader Enhance 2 Blood Glucose Meter has a green color appearance and is equipped with a BLE Bluetooth module for wireless transmission, not relating to the effectiveness and accuracy aspects. The new version of the GlucoLeader Enhance 2 Blood Glucose Meter can be used directly with the GlucoLeader Enhance 2 Blood Glucose Test Strip without any difference. Although there are some specifications that are different between subject device and predicate device (K182428), the test results complied with the test requests, and this demonstrates that the differences between these parameters would not impact the safety and effectiveness of the subject device. Therefore, the difference between the subject device and the predicate device did not raise any problem of substantial equivalence. The subject device is substantially equivalent to the predicate device in intended use, safety and performance claims. The conclusions drawn from the non-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 device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
August 29, 2022
HMD BioMedical Inc. Chin-Hsiung Hsu Product Manager No. 181, Minsheng Street Hsinchu County, 30548 Taiwan
Re: K212248
Trade/Device Name: GlucoLeader Enhance 2 Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW Dated: June 10, 2022 Received: June 21, 2022
Dear Chin-Hsiung Hsu:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Paula Caposino, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212248
Device Name
GlucoLeader Enhance 2 Blood Glucose Monitoring System
Indications for Use (Describe)
The GlucoLeader Enhance 2 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 2 Blood Glucose Monitoring System is comprised of the GlucoLeader Enhance 2 Blood Glucose Meter and the GlucoLeader Enhance 2 Blood Glucose Test Strips. The GlucoLeader Enhance 2 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 (over the counter [OTC]) as an aid to monitor the effectiveness of diabetes control. The GlucoLeader Enhance 2 Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. GlucoLeader Enhance 2 Blood Glucose Monitoring System is not for use in neonates.
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K212248
510(k) SUMMARY
1. Submitter
HMD BioMedical Inc.
| Address: | No.181, Minsheng Street., Xinpu Township, Hsinchu
County 30548, Taiwan (R.O.C.) |
|----------------|------------------------------------------------------------------------------------|
| Phone: | +886-3-589-5000 |
| Fax: | +886-3-588-5500 |
| Contact: | Mr. Chin-Hsiung Hsu, Product Manager |
| Date Prepared: | August 29, 2022 |
2. Identification of the Device
| Proprietary/Trade name: | GlucoLeader Enhance 2 Blood Glucose
Monitoring System |
|------------------------------|----------------------------------------------------------|
| Model Number: | Enhance 2 |
| Classification Product Code: | NBW |
| Regulation Number: | 862.1345 |
| Regulation Description: | Glucose test system |
| Review Panel: | Clinical Chemistry |
| Device Class: | II |
3. Identification of the Predicate Device
| Predicate Device Name: | GlucoLeader Enhance Blood Glucose
Monitoring System |
|------------------------------|--------------------------------------------------------|
| Manufacturer: | HMD BioMedical Inc. |
| Classification Product Code: | NBW |
| Regulation number: | 862.1345 |
| Device Class: | II |
| 510(k) Number: | K182428 |
4
4. Device Description
The GlucoLeader Enhance 2 Blood Glucose Monitoring System is designed to pursuit the accuracy in blood glucose monitoring to provide with testing. The GlucoLeader Enhance 2 Blood Glucose Monitoring System mainly consists of four parts as below,
- (1) GlucoLeader Enhance 2 Blood Glucose Meter
- GlucoLeader Enhance 2 Blood Glucose Test Strips* (2)
- Glucose Control Solutions (L1, L2)* (3)
- (4) 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.
Display screen size of the meter is 1.73" x 1.7", and weight of the meter is 0.122 lbs (55.2 grams). The GlucoLeader Enhance 2 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.
The GlucoLeader Enhance 2 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 the GlucoLeader Enhance 2 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.
5. Intended Use/ Indications for Use of the Device
The GlucoLeader Enhance 2 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 2
5
Blood Glucose Monitoring System is comprised of the GlucoLeader Enhance 2 Blood Glucose Meter and the GlucoLeader Enhance 2 Blood Glucose Test Strips. The GlucoLeader Enhance 2 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 (over the counter [OTC]) as an aid to monitor the effectiveness of diabetes control. The GlucoLeader Enhance 2 Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. GlucoLeader Enhance
6. Comparison of Differences and Substantial Equivalence Determination
2 Blood Glucose Monitoring System is not for use in neonates.
The GlucoLeader Enhance 2 submitted in this 510(k) file is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared GlucoLeader Enhance (K182428). Differences between the devices cited in the following do not raise any new issue of substantial equivalence.
| Feature | Subject device
K212248 | Predicate device
K182428 | SE determination |
|---------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Meter
Appearance | Image: GlucoLeader meter in green color
Green color | Image: GlucoLeader meter in blue color
Blue color | Equivalent
Although the shell colors of the subject
device and the predicate device are
different, but their materials (PMMA) are
the same, and the differences between
these devices does not raise new issue of
substantial equivalence. |
| Methodology | Amperometry glucose
biosensor | Amperometry glucose
biosensor | Same |
| Meter
Dimension | 3.81 in(L) × 2.36 in
(W) × 0.65in (H) | 3.81 in(L) × 2.36 in
(W) × 0.65in (H) | Same |
| Feature | Subject device
K212248 | Predicate device
K182428 | SE determination |
| Measuring
Range | 10 to 600 mg/dL (0.6
to 33.3 mmol/L) | 10 to 600 mg/dL (0.6
to 33.3 mmol/L) | Same |
| Resolution | 1 mg/dL LCD display | 1 mg/dL LCD display | Same |
| Reaction Time | 5 seconds | 5 seconds | Same |
| Operating
Environment | 8-44°C,
10-90% R.H. | 8-44°C,
10-90% R.H. | Same |
| Storage
Environment | -25-70°C,
10-90% R.H. | -25-70°C,
10-90% R.H. | Same |
| Power Source | One parallel connected
lithium batteries
(3V, CR2032) | One parallel connected
lithium batteries
(3V, CR2032) | Same |
| Battery
Operation Life | More than
1000 times test | More than
1000 times test | Same |
| Data
memory/Recall | Storage 800 test results | Storage 800 test results | Same |
| Labeling | Model: Enhance 2;
Rename the test strip:
GlucoLeader Enhance
2 Test Strips | Model: Enhance | Different
Different in product model and strip name.
However, it does not affect the intended
use or alter the fundamental scientific
technology of subject device. |
| PCB layout | Add BLE module | No BLE Module | Different
The change is the addition of a BLE
module on the PCBA.
However, it does not affect the intended
use or alter the fundamental scientific
technology of subject device. |
| Wireless
communication | Bluetooth Low Energy
V4.0 (optional) | N/A | Different
The device is only allowed to complete the
pairing connection and send data after the
blood glucose test is completed or the |
| Feature | Subject device | Predicate device | SE determination |
| | K212248 | K182428 | |
| | | | connection mode is turned on. The |
| | | | transmission is under the authorization of |
| | | | the user. |
| | | | However, it does not affect the intended |
| | | | use or alter the fundamental scientific |
| | | | technology of subject device. |
6
HMD BioMedical Inc.
GlucoLeader Enhance 2 (Enhance 2)
K212248
7
HMD BioMedical Inc. GlucoLeader Enhance 2 (Enhance 2)
7. Non-clinical Testing
The GlucoLeader Enhance 2 has been compared with "GlucoLeader Enhance (K182428)" according to the above table. The subject device has same intended use, principle of operation as the predicate device. We have completed the design control process and the validation tests to confirm the safety and performance of subject device. This change was for:
-
- The color of the meter appearance changed from blue to green.
- Rename the test strip which is dedicated to Enhance 2 system. 2.
-
- Add the Bluetooth function to the meter, changes including PCB layout, firmware for BLE pairing and transmission, and wireless communication.
After the risk management process, GlucoLeader Enhance 2 was validated. The verification and validation activities are summarized as below.
- . Software validation and wireless security, including SweynTooth vulnerabilities and cybersecurity evaluation, complied with Guidance on software validation, wireless technology and cybersecurity.
- . Electromagnetic compatibility (EMC), conducted and complied with IEC 60601-1-2.
After testing, it guarantees the security of data transmission will not be interfered by other products with BLE, and can transmit multiple data at the same time. All data are correct, and they prove the reliability and accuracy of the GlucoLeader Enhance 2.
8
8. Clinical Testing
No new clinical test data was used to support the decision of substantial equivalence.
9. Conclusion
The new version of the GlucoLeader Enhance 2 Blood Glucose Meter has a green color appearance and is equipped with a BLE Bluetooth module for wireless transmission, not relating to the effectiveness and accuracy aspects. The new version of the GlucoLeader Enhance 2 Blood Glucose Meter can be used directly with the GlucoLeader Enhance 2 Blood Glucose Test Strip without any difference.
Although there are some specifications that are different between subject device and predicate device (K182428), the test results complied with the test requests, and this demonstrates that the differences between these parameters would not impact the safety and effectiveness of the subject device. Therefore, the difference between the subject device and the predicate device did not raise any problem of substantial equivalence. The subject device is substantially equivalent to the predicate device in intended use, safety and performance claims.
The conclusions drawn from the non-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 device.