(241 days)
Not Found
No
The description focuses on standard blood glucose monitoring technology and does not mention any AI or ML components.
No
The device is a diagnostic tool for monitoring blood glucose levels, not for treating or providing therapy for a medical condition.
No
The device is explicitly stated as "not intended for the diagnosis of, or screening of diabetes." It is an aid in monitoring effectiveness of a diabetes control program.
No
The device description explicitly states the system is comprised of a glucose meter and blood glucose test strips, which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The ActiveCare TD-4121 Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use)..."
This statement directly identifies the device as an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ActiveCare TD-4121 Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) in the quantitative measurement of glucose in fresh capillary whole blood taken from the finger. It is intended to be used by people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. The ActiveCare TD-4121 Blood Glucose Monitoring System is comprised of the ActiveCare TD-4121 glucose meter and the ActiveCare TD-4121 blood glucose test strip. The ActiveCare TD-4121 Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. The ActiveCare TD-4121 Blood Glucose Monitoring System is not intended for the diagnosis of, or screening of diabetes. It is not intended for use on neonates.
Product codes (comma separated list FDA assigned to the subject device)
NBW
Device Description
The ActiveCare TD-4121 Blood Glucose Monitoring System is comprised of the ActiveCare TD-4121 glucose meter and the ActiveCare TD-4121 blood glucose test strip. They have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. Use only ActiveCare TD-4121 blood glucose test strip with ActiveCare TD-4121 Blood Glucose Monitoring System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fresh capillary whole blood taken from the finger
Indicated Patient Age Range
Not intended for use on neonates.
Intended User / Care Setting
people with diabetes mellitus 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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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).
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§ 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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 12, 2018
TaiDoc Technology Corporation Anne Kuo Scientific Reviewer B1-7F, No. 127, Wugong 2nd Rd. Wugu District New Taipei City 24888. Taiwan
Re: K173511
Trade/Device Name: ActiveCare TD-4121 Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: June 9, 2018 Received: June 13, 2018
Dear Anne Kuo:
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. 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 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR
1
Part 820); 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 -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 (if known) K173511
Device Name
ActiveCare TD-4121 Blood Glucose Monitoring System
Indications for Use (Describe)
The ActiveCare TD-4121 Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) in the quantitative measurement of glucose in fresh capillary whole blood taken from the finger. It is intended to be used by people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program.
The ActiveCare TD-4121 Blood Glucose Monitoring System is comprised of the ActiveCare TD-4121 glucose meter and the ActiveCare TD-4121 blood glucose test strip.
The ActiveCare TD-4121 Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.
The ActiveCare TD-4121 Blood Glucose Monitoring System is not intended for the diagnosis of, or screening of diabetes. It is not intended for use on neonates.
| 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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新北市24888万股區五工二路127號6樓 6F., No.127. Wugong 2nd Rd., Wugu Dist.
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
The assigned 510(k) number is: K173511
1. Submitter information
| Company name | TaiDoc Technology Corporation |
|---|---|
| Address | B1-7F, No. 127, Wugong 2nd Rd., Wugu District, |
| New Taipei City, 24888, Taiwan | |
| Phone | +886-2-6625-8188 #1195 |
| Fax | +886-2-6625-0288 |
| Contact person | Anne Kuo |
| Title | Regulatory Affairs Senior Specialist |
| anne.kuo@taidoc.com.tw | |
| ra.cert@taidoc.com.tw | |
| Prepared date | June 09, 2018 |
2. Device name
| Proprietary name | ActiveCare TD-4121 Blood Glucose Monitoring System |
|---|---|
| Common name | Blood Glucose Monitoring System |
| Product code | NBW, Blood Glucose Test System, Over-the-Counter |
| Classification panel | Clinical chemistry |
| Classification | Class II |
| Regulation citation | 21 CFR §862.1345, Glucose test system |
3. Predicate Device
| Proprietary Name: | TD-4277 Blood Glucose Monitoring System |
|---|---|
| Common Name: | Blood Glucose Monitoring System |
| 510(k) Number: | K100322 |
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科技股份有限公司
Intended use 4.
The ActiveCare TD-4121 Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) in the quantitative measurement of glucose in fresh capillary whole blood taken from the finger.
It is intended to be used by people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program.
The ActiveCare TD-4121 Blood Glucose Monitoring System is comprised of the ActiveCare TD-4121 glucose meter and the ActiveCare TD-4121 blood glucose test strip.
The ActiveCare TD-4121 Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.
The ActiveCare TD-4121 Blood Glucose Monitoring System is not intended for the diagnosis of, or screening of diabetes. It is not intended for use on neonates.
5. Device Description
The ActiveCare TD-4121 Blood Glucose Monitoring System is comprised of the ActiveCare TD-4121 glucose meter and the ActiveCare TD-4121 blood glucose test strip. They have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. Use only ActiveCare TD-4121 blood glucose test strip with ActiveCare TD-4121 Blood Glucose Monitoring System.
Comparison to the Predicate 6.
The modified ActiveCare TD-4121 Blood Glucose Monitoring System has the following similarities and modifications to the predicate device:
| Similarities | Modifications |
|---|---|
| 1. Operating principle | 1. Changed meter appearance and size |
| 2. Detection method and scientific technology | 2. Change battery type from 2 pieces of 3V AAA batteries to 1 Li-polymer battery. |
| 3. Employs the same test strip | 3. PCB layout change |
| 4. Operation and storage conditions | 4. Changed memory type from EEprom to FLASH |
| 5. Accuracy | 5. Revise the contents of user manuals and labeling |
| 6. Component materials | |
| 7. Packaging materials | |
| 8. Shelf life |
TaiDoc Technology Corporation
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Image /page/5/Picture/0 description: The image shows a document from TaiDoc Technology Corp. It lists several modifications made to a user interface, including changing from buttons to a touchscreen. The Gen/AC/PC function was modified into 8 tags, and error messages are different from predicate. Also, the manufacturing process and transmission function were removed.
7. Test principle
The blood glucose is based on the measurement of electrical current generated by the reaction of glucose with the reagent of the strip. The meter utilizes the current signal to calculate the blood glucose level.
Traceability 8.
This system is compared to the YSI-2300 Glucose Analyzer in the clinical and non-clinical studies. The YSI is calibrated with NIST (SRM) 917A reference material.
9. Conclusion
Based on the information provided in this submission, the ActiveCare TD-4121 Blood Glucose Monitoring System and TD-4277 Blood Glucose Monitoring System are substantially equivalent.