(24 days)
Not Found
No
The summary describes a standard electrochemical blood glucose monitoring system with the addition of Bluetooth connectivity. There is no mention of AI or ML in the device description, intended use, or performance studies. The core technology is based on a chemical reaction and electrical current measurement, not data-driven algorithms for interpretation or prediction.
No
The device is an in vitro diagnostic (IVD) device used for monitoring blood glucose levels, not for directly treating a medical condition.
Yes
The device is described as an "In Vitro diagnostic use" system, intended for the quantitative measurement of glucose to "aid to monitor the effectiveness of diabetes control."
No
The device description explicitly states the system consists of a blood glucose meter and test strips, which are hardware components. The modification involves adding a Bluetooth dongle to the meter, further confirming the presence of hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "Testing is done outside the body (In Vitro diagnostic use)."
- Nature of the Test: The device measures glucose in a blood sample outside the body, which is the definition of an in vitro diagnostic test.
- Purpose: It is used to monitor the effectiveness of diabetes control, which is a diagnostic purpose.
N/A
Intended Use / Indications for Use
The EasyMax BT 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 EasyMax BT meter and the EasyMax BT test strips. The EasyMax BT meter only is used with the EasyMax BT 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 EasyMax BT SMBGS is derived from the existing device of EasyMax MU SMBGS with the addition of a Bluetooth dongle on the meter. The 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 system also includes the control solution which is used to check the performance of the system.
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)
Risk analysis was conducted according to ISO 14971:2007 standard. A Failure Modes and Effects Analysis (FMEA) was assessed to identify potential hazards and unaccepted risks, such as transmission/communication problems, safety issues, and operating BT function. Control measures included Safety and EMC testing, FCC testing, Software function testing, and a human factor study.
Verification and Validation Activities:
- Addition of the Bluetooth dongle to the meter:
- Safety Test (IEC 61010-1:2010; IEC61010-2-101:2002)
- EMC Test (IEC 60601-1-2:2014; 61326-1:2001)
- FCC test (FCC Part 15 Subpart B & C)
- Human Factor Test (IEC 62366-1:2015)
- Drop and Vibration Test (ISTA 2A: 2011; IEC60068-2-64: 2008)
- Software (firmware) changes for Bluetooth pairing and Bluetooth transmission functions:
- Software Validation Test (IEC 62304:2006; FDA guidance Document "Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices")
- Change product name:
- Readability Test (For all inserts, the accept criteria: Flesch-Kincaid grade level
§ 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 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.
August 24, 2018
EPS Bio Technology Corp. Cynthia Hung Official Correspondent No. 8, R&D Rd. III Hsinchu Science Park Hsinchu. 30077 Taiwan
Re: K182057
Trade/Device Name: EasyMax BT Self-Monitoring Blood Glucose System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: July 30, 2018 Received: July 31, 2018
Dear Cynthia Hung:
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.
1
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 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.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/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 -S
for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number K182057
Device Name
EasyMax BT Self Monitoring Blood Glucose system
Indications for Use (Describe)
The EasyMax BT 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 EasyMax BT meter and the EasyMax BT meter only is used with the EasyMax BT 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) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------- |
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3
July, 16, 2018
Type of 510(k): Special 510(k)
510(k) number: K182057
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: | Cynthia Hung |
| E-mail: | cynthia@epsbio.com.tw |
Device Name
| Proprietary Name: | EasyMax BT Self-Monitoring Blood Glucose System |
|---|---|
| Common Name: | Blood Glucose Test System |
| Product Code: | NBW |
| Classification Name: | Blood Glucose Test System, Over-the Counter |
| Classification: | Class II |
| Regulation Number: | 21 CFR 862.1345 |
Predicate Device
| Proprietary Name: | EasyMax MU Self-Monitoring Blood Glucose System |
|---|---|
| 510(k) Number: | K121207 |
Device Description
The modified device of EasyMax BT SMBGS is derived from the existing device of EasyMax MU SMBGS with the addition of a Bluetooth dongle on the meter. The 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 system also includes the control solution which is used to check the performance of the system.
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.
4
Intended Use
The EasyMax BT 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 EasyMax BT meter and the EasyMax BT test strips. The EasyMax BT meter only is used with the EasyMax BT test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm.
| Similarities and Differences | ||
|---|---|---|
| Item | Predicate Device | Modified Device |
| Name | EasyMax MU | |
| K121207 | EasyMax BT | |
| Intended use | EasyMax MU 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 type | Fresh capillary whole blood | Same as predicate |
| Sample site | Finger, palm or forearm. | Same as predicate |
| Sample Volume | 0.6 uL | Same as predicate |
| Reaction Time | 5 seconds | Same as predicate |
| Measuring Range | 20-600 mg/dL | Same as predicate |
| Hematocrit Range | 20-60% | Same as predicate |
| Operating | ||
| condition | 50-104°F(10-40°C) |