K Number
K190189
Device Name
MDT2 BLE Self-Monitoring Blood Glucose System
Date Cleared
2019-11-01

(273 days)

Product Code
Regulation Number
862.1345
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MDT2 BLE Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood from fingertip, palm, or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions. The system consists of the MDT2 BLE meter and the MDT2 BLE test strips. The MDT2 BLE meter only is used with the MDT2 BLE test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm.
Device Description
The modified device of MDT2 BLE glucose meter is derived from the existing device of EM40 glucose meter and the modified device contain the Bluetooth function to transfer glucose results to the mobile app. The self-monitoring blood glucose system consists of a blood glucose meter and test strips which are designed, tested, and verified to work together as a system to produce accurate blood glucose test results. The electrochemical principle on the test strip is the reaction of FAD glucose dehydrogenase (FAD-GDH) with blood glucose and a small electrical current generated proportional to the glucose concentration in the blood sample. The meter measures the current and displays the blood glucose result.
More Information

Not Found

No
The description focuses on the electrochemical principle of glucose measurement and the addition of Bluetooth functionality for data transfer. There is no mention of AI or ML in the intended use, device description, or the "Mentions AI, DNN, or ML" section.

No.
The device is a self-monitoring blood glucose system intended for the quantitative measurement of glucose, which aids in monitoring the effectiveness of diabetes control, not for treatment.

Yes
The device is described as a "Self Monitoring Blood Glucose System" and states its intended use is for "quantitative measurement of glucose" as an "aid to monitor the effectiveness of diabetes control." These phrases indicate its function is to provide data for the assessment and management of a medical condition, which is a diagnostic purpose.

No

The device description explicitly states the system consists of a blood glucose meter and test strips, which are hardware components. While it includes a Bluetooth function to transfer data to a mobile app, the core functionality relies on physical hardware for measurement.

Yes, this device is an IVD (In Vitro Diagnostic).

The "Intended Use / Indications for Use" section explicitly states:

"Testing is done outside the body (In Vitro diagnostic use)."

This statement directly identifies the device as being used for in vitro diagnostic purposes.

N/A

Intended Use / Indications for Use

The MDT2 BLE Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood from fingertip, palm, or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.

The system consists of the MDT2 BLE meter and the MDT2 BLE test strips. The MDT2 BLE meter only is used with the MDT2 BLE test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm.

Product codes

NBW

Device Description

The modified device of MDT2 BLE glucose meter is derived from the existing device of EM40 glucose meter and the modified device contain the Bluetooth function to transfer glucose results to the mobile app.

The self-monitoring blood glucose system consists of a blood glucose meter and test strips which are designed, tested, and verified to work together as a system to produce accurate blood glucose test results.

The electrochemical principle on the test strip is the reaction of FAD glucose dehydrogenase (FAD-GDH) with blood glucose and a small electrical current generated proportional to the glucose concentration in the blood sample. The meter measures the current and displays the blood glucose result.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Fingertip, palm, or forearm

Indicated Patient Age Range

The system is not to be used on neonates

Intended User / Care Setting

Use at home (over the counter [OTC]) by a single patient with diabetes.

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)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K133389

Reference Device(s)

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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "HUMAN SERVICES-USA" around the edge. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

November 1, 2019

EPS Bio Technology Corp. RF Jain No. 8 R&D RD.III Hsinchu Science Park Hsinchu, 30077 Taiwan

Re: K190189

Trade/Device Name: MDT2 BLE Self-Monitoring Blood Glucose System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: October 1, 2019 Received: October 2, 2019

Dear RF Jain:

We have reviewed vour 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

1

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 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 medical devices and radiation-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,

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

Indications for Use

510(k) Number (if known) K190189

Device Name

MDT2 BLE Self Monitoring Blood Glucose system

Indications for Use (Describe)

The MDT2 BLE Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood from fingertip, palm, or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.

The system consists of the MDT2 BLE meter and the MDT2 BLE test strips. The MDT2 BLE meter only is used with the MDT2 BLE test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm.

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

EPS Bio Technology Corp.

510(K) Summary of MDT2 BLE Self-monitoring Blood Glucose System (As required by 21 CFR 807.92)

September 30, 2019

Type of 510(k):Special 510(k)K190189
Submitter Information
Company Name:EPS Bio Technology Corp.
Address:No. 8, R&D Rd.III Hsinchu Science Park, Hsinchu city
30077 Taiwan, R.O.C
Phone:+886-3-6686-868
Fax:+886-3-6686-866
Contact Person:RF Jain
E-mail:rf_jain@epsbio.com.tw
Device Name
Proprietary Name:MDT2 BLE Self-Monitoring Blood Glucose System
Common Name:Blood Glucose Test System
Product Code:NBW
Classification NameBlood Glucose Test System, Over-the Counter
Classification:Class II
Regulation Number:21 CFR 862.1345
Predicate Device
Proprietary Name:EM40 Self-Monitoring Blood Glucose System
510(k) Number:K133389

Device Description

The modified device of MDT2 BLE glucose meter is derived from the existing device of EM40 glucose meter and the modified device contain the Bluetooth function to transfer glucose results to the mobile app.

The self-monitoring blood glucose system consists of a blood glucose meter and test strips which are designed, tested, and verified to work together as a system to produce accurate blood glucose test results.

The electrochemical principle on the test strip is the reaction of FAD glucose dehydrogenase (FAD-GDH) with blood glucose and a small electrical current generated proportional to the glucose concentration in the blood sample. The meter measures the current and displays the blood glucose result.

Intended Use

The MDT2 BLE Self-Monitoring Blood Glucose System is intended for the

4

September 30, 2019

quantitative measurement of glucose in fresh capillary whole blood from fingertip, palm, or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.

The system consists of the MDT2 BLE meter and the MDT2 BLE test strips. The MDT2 BLE meter only is used with the MDT2 BLE test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm.

Similarities and Differences
ItemPredicate DeviceModified Device
NameEM40
K133389MDT2 BLE
Intended useEM40 Self-Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood from fingertip, palm, or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.Same as predicate
Sample typeFresh capillary whole bloodSame as predicate
Sample siteFinger, palm or forearm.Same as predicate
Sample Volume0.6 uLSame as predicate
Reaction Time5 secondsSame as predicate
Measuring Range20-600 mg/dLSame as predicate
Hematocrit Range20-60%Same as predicate
Operating condition50-104°F(10-40°C)