(90 days)
Not Found
No
The summary describes a standard blood glucose monitoring system and does not mention any AI or ML capabilities. The performance studies focus on standard device validation metrics.
No.
The device is described as a "Blood Glucose Monitoring System" and is intended for "monitoring the effectiveness of the diabetes control program." It is not directly treating or alleviating a disease but rather providing information for management.
Yes
Explanation: The device is intended for quantitative measurement of glucose in fresh capillary whole blood and aids in monitoring the effectiveness of diabetes control. While it's explicitly stated that it's "not intended for the diagnosis of or screening for diabetes mellitus," monitoring and aiding in effectiveness of a control program falls under the umbrella of diagnostic use where it provides information on a health state.
No
The device description explicitly states that the system includes a "TD-4183 Blood Glucose meter with blood glucose measuring function" and "TD-4183 Blood Glucose test strips," which are hardware components. The performance studies also mention electrical/mechanical safety tests and disinfection studies, further indicating the presence of hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
The Intended Use section explicitly states: "This system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes mellitus at home..."
The Device Description also mentions: "This system is a single-patient use blood glucose monitoring system intended to be used to quantitatively measure glucose in fresh capillary whole blood from the finger as an aid in monitoring the effectiveness of glucose control."
These statements clearly indicate that the device is intended for testing biological samples (blood) outside of the body to provide information about a medical condition (glucose levels related to diabetes), which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The TD-4183 Blood Glucose Monitoring System consists of the TD-4183 Blood Glucose meter and the TD-4183 Blood Glucose Test Strips.
The TD-4183 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the fingertip. This system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes mellitus at home as an aid in monitoring the effectiveness of the diabetes control program. It is intended to be used by single person and should not be shared. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
Product codes (comma separated list FDA assigned to the subject device)
NBW
Device Description
The TD-4183 system kit includes the TD-4183 Blood Glucose meter with blood glucose measuring function and the TD-4183 Blood Glucose test strips. This system is a single-patient use blood glucose monitoring system intended to be used to quantitatively measure glucose in fresh capillary whole blood from the finger as an aid in monitoring the effectiveness of glucose control.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertip
Indicated Patient Age Range
Not intended for use on neonates.
Intended User / Care Setting
People with diabetes mellitus at home. Intended for self-testing.
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)
Non-clinical and clinical studies were conducted to test, verify and validate the performance of the proposed device according to FDA Guidance issued on October 11, 2016: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use. Results from these studies show that all performance criteria were met.
Non-Clinical Testing Summary: Design verification and validation testing was performed to ensure that the TD-4183 System met design specifications and requirements. Testing activities included electrical/mechanical safety tests, functional performance tests (precision, linearity, interference, flex studies) as well as disinfection, cleaning, and robustness studies. Software validation was performed for this moderate level of concern device per FDA Guidance Content of Premarket Submissions for Software Contained in Medical Devices.
Clinical Testing Summary: A user evaluation confirmed the system accuracy, operation according to design, and ease of use to support the intended use as described in the proposed labeling.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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).
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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June 4, 2019
TaiDoc Technology Corporation Sophia Wu Regulatory Affairs Vice President 6F. No.127. Wugong 2nd Rd., Wugu District New Taipei City, 24888 Taiwan
Re: K190579
Trade/Device Name: TD-4183 Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW Dated: February 27, 2019 Received: March 6, 2019
Dear Sophia Wu:
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.
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
1
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 (OS) 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 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-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
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Indications for Use
510(k) Number (if known) K190579
Device Name TD-4183 Blood Glucose Monitoring System
Indications for Use (Describe)
The TD-4183 Blood Glucose Monitoring System consists of the TD-4183 Blood Glucose meter and the TD-4183 Blood Glucose Test Strips.
The TD-4183 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the fingertip. This system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes mellitus at home as an aid in monitoring the effectiveness of the diabetes control program. It is intended to be used by single person and should not be shared. It is not intended for the diagnosis of or screening for diabetes mellitus, and 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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510(k) Summary
Submission Number: K190579
In accordance with the requirements of 21 CFR 807.92, this summary is being provided to serve as the basis for the substantial equivalence determination.
Submitter information
| Manufacturer | TaiDoc Technology Corporation |
|---|---|
| Address | 6F, No. 127, Wugong 2nd Rd. Wugu Dist. |
| New Taipei City, Taiwan 24888 | |
| Establishment Registration No. | 3004145393 |
| Date Prepared | May 10, 2019 |
| Correspondent | TaiDoc Technology Corporation |
| Correspondent Contact | Sophia Wu |
| Title | Regulatory Affairs Vice President |
| Phone | +886-2-6625-8188 |
Proposed Device Information
| Proprietary name | TD-4183 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 | 2 |
| Regulation Number | 21 CFR §862.1345 |
Predicate Device Information
| Manufacturer | TaiDoc Technology Corporation |
|---|---|
| Proprietary Name | TD-4277 Blood Glucose Monitoring System |
| Common Name | Blood Glucose Monitoring System |
| 510(k) Number | K100322 |
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Intended use
The TD-4183 Blood Glucose Monitoring System consists of the TD-4183 Blood Glucose meter and the TD-4183 Blood Glucose Test Strips.
The TD-4183 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the fingertip. This system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes mellitus at home as an aid in monitoring the effectiveness of the diabetes control program. It is intended to be used by single person and should not be shared. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
Device Description
The TD-4183 system kit includes the TD-4183 Blood Glucose meter with blood glucose measuring function and the TD-4183 Blood Glucose test strips. This system is a single-patient use blood glucose monitoring system intended to be used to quantitatively measure glucose in fresh capillary whole blood from the finger as an aid in monitoring the effectiveness of glucose control.
Test principle
The blood sample is applied to the absorbent hole at the end of the test strip to fill the window. When the blood sample is absorbed into the test strip, the blood glucose reacts with the reagent contained in the test strip and generates electrical current. When the meter receives the signal through the connector, the signal is then transferred into calculated blood glucose level and displayed on the LCD screen. The strength of the current produced by the reaction depends on the amount of glucose in the blood sample.
Summary of Technological Characteristics and Comparison to the Predicate
The TD-4183 Blood Glucose Monitoring System is substantially equivalent to the predicate device in terms of technological characteristics.
The similarities and differences between the predicate and proposed devices are summarized in Table 1 and 2 below.
CONFIDENTIAL
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泰博科技股份有限公司 TaiDoc Technology Corp.
新北市24888五股區五工二路127號6樓 6F., No.127, Wugong 2nd Rd., Wugu Dist., New Taipei City 24888, Taiwan
Tel : +886-2-6625-8188 Fax : +886-2-6625-0288
| Table 1: Similarities between the Predicate and Proposed Device | ||||
|---|---|---|---|---|
| ----------------------------------------------------------------- | -- | -- | -- | -- |
| Characteristic | Predicate device
TD-4277 | Proposed device
TD-4183 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| Operation principle | Electrochemical biosensor
technology | the same as the predicate device |
| Detection method | Amperometric glucose biosensor | the same as the predicate device |
| Mode of operation | User initiates test on meter, inserts
test strip into meter, lances finger
with lancing device, and places blood
sample on test strip. | the same as the predicate device |
| Strip preparation | Strips are stored in a
humidity-controlled vial (25-50 strips
per vial), user removes one strip from
vial and inserts in meter for testing. | the same as the predicate device |
| Code calibration | No coding required | the same as the predicate device |
| Strip enzyme | FAD Glucose dehydrogenase ( E. coli ) | the same as the predicate device |
| Strip reaction time | 6 seconds | the same as the predicate device |
| Strip sample volume | 0.5 µL | the same as the predicate device |
| Measurement unit | mg/dL | the same as the predicate device |
| Measurement modes | AC (before meal)
PC (after meal)
Gen (not specified)
QC (quality control) | the same as the predicate device |
| User interface | LCD and buttons | the same as the predicate device |
| Display of test results | LCD screen | the same as the predicate device |
| Software design | Meter software controls the
measurement and calculation of
blood glucose and displays result on
the meter. | the same as the predicate device |
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泰博科技股份有限公司 TaiDoc Technology Corp.
新北市24888五股區五工二路127號6樓 6F., No.127, Wugong 2nd Rd., Wugu Dist., New Taipei City 24888, Taiwan
| Table 2: Differences between the Predicate and Proposed Device |
|---|
| Characteristic | Predicate device
TD-4277 | Proposed device
TD-4183 |
|-----------------------------------------------|---------------------------------|---------------------------------|
| Physical Appearance | Image: Predicate device TD-4277 | Image: Proposed device TD-4183 |
| Meter Size (mm) | 96 (L) x 61 (W) x 26 (H) | 90.3 (L) x 52.3 (W) x 18 (H) |
| Meter Weight (g) | 67.2 g | 46.8 g |
| Measurement range | 20-600 mg/dL | 20-650 mg/dL |
| Hematocrit range | 20-60% | 20-65% |
| Power source | 2 x 1.5V AAA batteries | 1 x 1.5V AAA batteries |
| Transmission function | USB | NA |
| Meter storage/
transportation
condition | -4°F to 140°F,