ActiveCare TD-4121 Blood Glucose Monitoring System

K173511 · Taidoc Technology Corporation · NBW · Jul 12, 2018 · Clinical Chemistry

Device Facts

• Record ID: K173511
• Device Name: ActiveCare TD-4121 Blood Glucose Monitoring System
• Applicant: Taidoc Technology Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jul 12, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

System consists of glucose meter and test strips; measures glucose in capillary whole blood. Principle: electrochemical reaction between glucose and strip reagent generates electrical current; meter calculates glucose concentration from current. Used by patients with diabetes at home for monitoring control program effectiveness. Single-patient use only. Output displayed to patient to inform diabetes management. Modifications from predicate include touchscreen interface, Li-polymer battery, PCB layout, and memory type (FLASH).

Clinical Evidence

System performance compared against YSI-2300 Glucose Analyzer (calibrated with NIST SRM 917A). No specific clinical trial metrics (e.g., sensitivity, specificity) provided in summary; equivalence established via bench testing and comparison to predicate.

Technological Characteristics

Glucose meter; electrochemical sensing; rechargeable Li-polymer battery; FLASH memory; touchscreen interface; micro-USB port (charging only); multi-language support; dimensions/form factor modified from predicate; sterilization not applicable (home-use device).

Indications for Use

Indicated for single-patient home use for the monitoring of blood glucose levels.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• TD-4277 Blood Glucose Monitoring System (k100322)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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### 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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Image /page/3/Picture/0 description: The image shows the logo for TaiDoc. The logo consists of the word "TaiDoc" in gray letters above three red hearts. Below the hearts is a gray bar with the website address "www.taidoc.com" written in white.

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,<br>New Taipei City, 24888, Taiwan |
| Phone | [phone] #1195 |
| Fax | [phone] |
| Contact person | Anne Kuo |
| Title | Regulatory Affairs Senior Specialist |
| E-mail | [e-mail]<br>[e-mail] |
| 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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Image /page/4/Picture/0 description: The image shows the logo for TaiDoc. The logo consists of the word "TaiDoc" in gray letters above three red hearts. Below the hearts is the website address "www.taidoc.com" in white letters on a gray background.

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.