(125 days)
No reference device is used in this submission.
No
The description focuses on the electrochemical measurement method and standard performance studies, with no mention of AI or ML.
No.
The device is intended to monitor glucose levels, which aids in monitoring the effectiveness of diabetes control, but it does not directly treat or cure the condition.
No
Explanation: The device is explicitly stated as "not intended for neonatal use or for the diagnosis of or screening for diabetes." Instead, it is intended to aid persons with diabetes in monitoring the effectiveness of diabetes control.
No
The device description explicitly states that the system consists of a "TeleRPM Gen2 Blood Glucose Meter" and "TeleRPM Blood Glucose Test Strips," which are hardware components. It also mentions a "4G module" within the device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "This system is intended for self-testing outside the body (in vitro diagnostic use)".
Furthermore, the device measures glucose concentration in fresh capillary whole blood samples, which is a biological sample tested in vitro (outside the body) to provide diagnostic information.
N/A
Intended Use / Indications for Use
TeleRPM Gen2 Blood Glucose Monitoring System is comprised of the TeleRPM Gen2 Blood Glucose Meter and the TeleRPM Blood Glucose Test Strips. TeleRPM Gen2 Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.
Product codes
NBW
Device Description
TeleRPM Gen2 Blood Glucose Monitoring System consists of TeleRPM Gen2 Blood Glucose Meter and the TeleRPM Blood Glucose Test Strips.
TeleRPM Control Solution, TeleRPM Lancing Device, TeleRPM Lancets are required for use but not included in meter box or test strips box and should be purchased separately. The TeleRPM Control Solution is for use with the above meter and test strip as a quality control check to verify that the meter and test strip are working together properly, and that the test is performing correctly. TeleRPM Lancing Device and TeleRPM Lancets are used for puncturing fingertip and then user can perform qlucose test with blood sample.
TeleRPM Gen2 Blood Glucose Monitoring System is designed to quantitatively measure the glucose concentration in fresh capillary whole blood from the fingertip. The glucose measurement is achieved by using the amperometric detection method. The test is based on measurement of electrical current caused by the reaction of the glucose with the reagents on the electrode of the test strip. The blood sample is pulled into the tip of the test strip through capillary action. Glucose in the sample reacts with glucose oxidase and the mediator. Electrons are generated, producing a current that is positive correlation to the glucose concentration in the sample. After the reaction time, the glucose concentration value is reported in plasma equivalents and is displayed on meter screen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertips
Indicated Patient Age Range
It is not intended for neonatal use.
Intended User / Care Setting
It is intended for use by persons 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 and testing activities included cleaning and disinfection, robustness, precision, linearity, user evaluation, interference evaluation, test strips stability, flex studies. The studies with performance data were provided in the submission to support of the substantial equivalence determination.
TeleRPM Gen2 Blood Glucose Monitoring System contains 4G module, the device complies with software and cybersecurity control guidance requirements based on the test reports and study reports.
Laboratory (nonclinical) studies were performed on the TeleRPM Gen2 Blood Glucose Monitoring System in accordance with the FDA SMBG OTC Guidance, CLSI guidelines and industry standards. Test data and results from laboratory studies showed that these devices performed as intended and met associated guidance documents and industry standards.
The TeleRPM Gen2 Blood Glucose Monitoring System has the same intended use, work principle and technological characteristics as VivaChek™ Link Plus Blood Glucose Monitoring System, clinical study (user evaluation) and usability evaluation were conducted with intended users using the TeleRPM Gen2 Blood Glucose Monitoring System. Studies result indicated that inexperienced lay persons were able to obtain blood glucose readings when using the TeleRPM Gen2 Blood Glucose Monitoring System, and the clinical study data showed that the clinical performance met the FDA SMBG OTC Guidance. All participants had the ability of understanding of the labeling, could use of the system and could interpret the testing results and error messages based on the usability evaluation reports. In addition, there was no adverse effect or complication occurred or identified during the clinical study including usability evaluation. Therefore, these studies support the intended use as described in the proposed labeling.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
No reference device is used in this submission.
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.
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January 30, 2025
Image /page/0/Picture/1 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 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.
Guangdong Transtek Medical Electronics Co., Ltd. Mark Qian Quality Director Zone A, No. 105, Dongli Road, Torch Development District Zhongshan, Guangdong 528437 China
Re: K243060
Trade/Device Name: TeleRPM Gen2 Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW Dated: December 27, 2024 Received: December 27, 2024
Dear Mark Qian:
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
assistance/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,
Joshua Balsam -S
Joshua M. Balsam, Ph.D. Branch Chief 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
3
Indications for Use
510(k) Number (if known) K243060
Device Name
TeleRPM Gen2 Blood Glucose Monitoring System
Indications for Use (Describe)
TeleRPM Gen2 Blood Glucose Monitoring System is comprised of the TeleRPM Gen2 Blood Glucose Meter and the TeleRPM Blood Glucose Test Strips. TeleRPM Gen2 Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.
| Type of Use (Select one or both, as applicable) |
|---|
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with 21 CFR 807.92.
The assigned 510(k) number is K243060
1. Submitter's Information:
1.1 Submitter's Name, Address and Telephone Number
Name: Guangdong Transtek Medical Electronics Co., Ltd.
Address: Zone A, No.105, Dongli Road, Torch Development District,
Zhongshan, 528437, Guangdong, China.
Telephone: + 86 0760 8828 2982
1.2 Contact Person:
Name: Mark Qian
Position: Quality Director
Email: mark.qian@vivachekbio.com
1.3 Date Updated for Summary
Jan 29, 2025
2. Devices Name
2.1 Proprietary Name:
TeleRPM Gen2 Blood Glucose Monitoring System
2.2 Common Name:
Glucose Test System
2.3 Classification Name:
Classification Name: Glucose Test System Regulation Number: 21 CFR 862.1345
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Regulatory Class: Class II Product Code: NBW
2.4 Predicate (Legally Marketed) Device
Predicate Name: VivaChek™ Link Plus Blood Glucose Monitoring System. 510(k) Number: K233058. Applicant: VivaChek Biotech (Hangzhou) Co., Ltd. No reference device is used in this submission.
3. Device Description
TeleRPM Gen2 Blood Glucose Monitoring System consists of TeleRPM Gen2 Blood Glucose Meter and the TeleRPM Blood Glucose Test Strips.
TeleRPM Control Solution, TeleRPM Lancing Device, TeleRPM Lancets are required for use but not included in meter box or test strips box and should be purchased separately. The TeleRPM Control Solution is for use with the above meter and test strip as a quality control check to verify that the meter and test strip are working together properly, and that the test is performing correctly. TeleRPM Lancing Device and TeleRPM Lancets are used for puncturing fingertip and then user can perform qlucose test with blood sample.
TeleRPM Gen2 Blood Glucose Monitoring System is designed to quantitatively measure the glucose concentration in fresh capillary whole blood from the fingertip. The glucose measurement is achieved by using the amperometric detection method. The test is based on measurement of electrical current caused by the reaction of the glucose with the reagents on the electrode of the test strip. The blood sample is pulled into the tip of the test strip through capillary action. Glucose in the sample reacts with glucose oxidase and the mediator. Electrons are generated, producing a current that is positive correlation to the glucose concentration in the sample. After the reaction time, the glucose concentration value is reported in plasma equivalents and is displayed on meter screen.
6
4. Intended Use:
TeleRPM Gen2 Blood Glucose Monitoring System is comprised of the TeleRPM Gen2 Blood Glucose Meter and the TeleRPM Blood Glucose Test Strips. TeleRPM Gen2 Blood Glucose Monitoring System is intended to quantitatively measure the glucose concentration in fresh capillary whole blood samples drawn from the fingertips. It is intended for use by persons with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for neonatal use or for the diagnosis of or screening for diabetes. This system is intended for self-testing outside the body (in vitro diagnostic use), and should only be used by a single person and should not be shared.
5. Comparison of Technological Characteristics with Predicate Device:
| Characteristics | Predicate: VivaChek ™ Link Plus
Blood Glucose Monitoring System
(K233058) | Candidate: TeleRPM Gen2
Blood Glucose Monitoring
System |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| Similarities | | |
| Intended Use | It is intended to quantitatively
measure the glucose concentration
in fresh capillary whole blood
samples drawn from the fingertips. It
is intended for use by persons with
diabetes at home as an aid to
monitor the effectiveness of
diabetes control. | Same |
| Operation Principle | Electrochemical biosensor | Same |
| Detection Method | Amperometric | Same |
| Strip Chemical
Composition | Glucose oxidase | Same |
| Measurement Result | Plasma Glucose | Same |
| Sample | Fresh capillary whole blood | Same |
| Unit of Measure | mg/dL | Same |
| Measurement
Range | 20-600 mg/dL | Same |
| Sample Volume | 0.8µL | Same |
- 5.1 Comparison of TeleRPM Gen2 Blood Glucose Monitoring System with the predicate:
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Applicant: Guangdong Transtek Medical Electronics Co., Ltd.
Address: Zone A, No. 105, Dongli Road, Torch Development District, Zhongshan, Guangdong 528437, China Contact: Mark Qian Email: mark.qian@vivachekbio.com
| Test Time | 5 seconds | Same |
|---|---|---|
| Operating Relative | ||
| Humidity | 10-90% (non-condensing) | Same |
| Operating | ||
| Temperature | 41-113°F | Same |
| Hematocrit Range | 20-70% | Same |
| Automatic Shutoff | 2 minutes after last action | Same |
| Power Source | Rechargeable 3.7 Volt DC nominal, | |
| lithium polymer battery (5V input | ||
| charge voltage) | Same | |
| Data Transmission | This meter features automatic | |
| transfer of glucose results to the | ||
| Cloud using 4G wireless mobile | ||
| communication | Same | |
| Differences | ||
| Battery Capacity | 800 mAh | 1,300 mAh |
| Memory | 500 records | 2,000 records |
| Dimensions | 100.9mm x 61.6mm x 23.7mm | 105.2mm x 60.2mm x |
| 17.5mm | ||
| Weight | Approximately 85g | Approximately 123g |
6. Laboratory (Nonclinical) and Clinical Studies
6.1 Studies/Tests with Performance Data
Study and testing activities included cleaning and disinfection, robustness, precision, linearity, user evaluation, interference evaluation, test strips stability, flex studies. The studies with performance data were provided in the submission to support of the substantial equivalence determination.
TeleRPM Gen2 Blood Glucose Monitoring System contains 4G module, the device complies with software and cybersecurity control guidance requirements based on the test reports and study reports.
6.2 Brief Discussion of Laboratory (Nonclinical) Studies:
Laboratory (nonclinical) studies were performed on the TeleRPM Gen2 Blood Glucose Monitoring System in accordance with the FDA SMBG OTC Guidance, CLSI guidelines and industry standards. Test data and results from laboratory studies showed that these devices performed as intended and met associated guidance documents and industry standards.
8
6.3 Brief Discussion of Clinical Study including Usability Evaluation:
The TeleRPM Gen2 Blood Glucose Monitoring System has the same intended use, work principle and technological characteristics as VivaChek™ Link Plus Blood Glucose Monitoring System, clinical study (user evaluation) and usability evaluation were conducted with intended users using the TeleRPM Gen2 Blood Glucose Monitoring System. Studies result indicated that inexperienced lay persons were able to obtain blood glucose readings when using the TeleRPM Gen2 Blood Glucose Monitoring System, and the clinical study data showed that the clinical performance met the FDA SMBG OTC Guidance. All participants had the ability of understanding of the labeling, could use of the system and could interpret the testing results and error messages based on the usability evaluation reports. In addition, there was no adverse effect or complication occurred or identified during the clinical study including usability evaluation. Therefore, these studies support the intended use as described in the proposed labeling.
7. Conclusion:
The nonclinical studies and clinical study results demonstrate that the TeleRPM Gen2 Blood Glucose Monitoring System performed as intended and met FDA SMBG OTC Guidance and industry standards. TeleRPM Gen2 Blood Glucose Monitoring System is as safe, as effective and perform as well as the predicate device.
Therefore, the candidate device TeleRPM Gen2 Blood Glucose Monitoring System is substantially equivalent to the predicate device VivaChek Link Plus Blood Glucose Monitoring System (K233058).