(192 days)
Not Found
No
The document describes a standard blood glucose and ketone monitoring system with a mobile application for display. There is no mention of AI, ML, or any advanced algorithms beyond basic measurement and display functions. The performance studies focus on accuracy and precision, typical for this type of device, and do not indicate the use of AI/ML for interpretation or prediction.
No.
This device is an in vitro diagnostic (IVD) device used for monitoring glucose and ketone levels. It is not intended for active treatment or prevention of a medical condition, making it a diagnostic device rather than a therapeutic one.
Yes.
The device quantifies glucose and ß-ketone levels to monitor the effectiveness of diabetes control, making it an in vitro diagnostic device. Although it is 'not for the diagnosis of or screening for diabetes,' it provides quantitative measurements that aid in monitoring a medical condition.
No
The device description explicitly states the system consists of a "Smart Dongle meter," "Smart Dongle blood glucose test strips," and "Smart Dongle ß-ketone test strips" in addition to the mobile application. These are hardware components.
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) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control."
This statement clearly identifies the device as being used in vitro (outside the body) for diagnostic purposes (monitoring diabetes control).
N/A
Intended Use / Indications for Use
The TD-4140 Smart Dongle Blood Glucose plus ß-ketone Monitoring System consists of the Smart Dongle blood glucose test strips, Smart Dongle {}-ketone test strips, and the Procheck mobile application as the display component of the system. This system is intended to be used for the quantitative measurement of glucose (sugar) and fketone in fresh capillary whole blood from the finger.
This system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is intended to be used by a single person and should not be shared. This system should not be used for the diagnosis of or screening for diabetes, nor for use on neonates.
Product codes (comma separated list FDA assigned to the subject device)
JIN
Device Description
The TD-4140 Smart Dongle Blood Glucose plus ß-ketone Monitoring System consists of the Smart Dongle meter, Smart Dongle blood glucose test strips, Smart Dongle 0-ketone test strips, and the Procheck mobile application as the display component of the system.
This system is compatible to iPhone series, including iPhone 4/4s, 5/5s, 6/6 plus, and iPod touch 5. These products have been designed, tested, and proven to work together as a system to produce accurate test results. The Smart Dongle meter should only be used with the Smart Dongle Blood Glucose test strips and the Smart Dongle ß-ketone test strips.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fresh capillary whole blood from the finger
Indicated Patient Age Range
The device should not be used for neonates.
Intended User / Care Setting
self-testing outside the body (in vitro diagnostic use) by people 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
Accuracy – blood glucose:
Results for glucose concentration
§ 862.1435 Ketones (nonquantitative) test system.
(a)
Identification. A ketones (nonquantitative) test system is a device intended to identify ketones in urine and other body fluids. Identification of ketones is used in the diagnosis and treatment of acidosis (a condition characterized by abnormally high acidity of body fluids) or ketosis (a condition characterized by increased production of ketone bodies such as acetone) and for monitoring patients on ketogenic diets and patients with diabetes.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
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May 4, 2018
TaiDoc Technology Corporation Anne Kuo Regulatory Affairs Specialist B1-7F, No. 127, Wugong 2nd Rd., Wugu District New Taipei City, 24888 Taiwan
Re: K173345
Trade/Device Name: TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System Regulation Number: 21 CFR 862.1435 Regulation Name: Ketones (nonquantitative) test system Regulatory Class: Class I, meets the limitation of exemptions 21 CFR 862.9(c)(5) Product Code: JIN Dated: March 31, 2018 Received: April 4, 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (if known) K173345
Device Name
TD-4140 Smart Dongle Blood Glucose plus ß-ketone Monitoring System
Indications for Use (Describe)
The TD-4140 Smart Dongle Blood Glucose plus [-ketone Monitoring System consists of the Smart Dongle blood glucose test strips, Smart Dongle {}-ketone test strips, and the Procheck mobile application as the display component of the system. This system is intended to be used for the quantitative measurement of glucose (sugar) and fketone in fresh capillary whole blood from the finger.
This system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is intended to be used by a single person and should not be shared. This system should not be used for the diagnosis of or screening for diabetes, nor 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
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: K173345
1. Applicant Information
| Company | TaiDoc Technology Corporation |
|---|---|
| Contact Person | Anne Kuo |
| Title | Regulatory Affairs Specialist |
| Address | 6F, No. 127, Wugong 2nd Rd., Wugu District, New Taipei City 24888, Taiwan |
| Phone | +886-2-6625-8188 #1195 |
| Fax | +886-2-6625-0288 |
| E-mail address | ra.cert@taidoc.com.tw / anne.kuo@taidoc.com.tw |
2. Device name
| Proprietary Name | TD-4140 Smart Dongle Blood Glucose plus ß-ketone Monitoring System |
|---|---|
| Common Name | ß-Ketone monitoring system |
| Product Code | JIN, Nitroprusside, Ketones (Urinary, Non-Quant.) |
| Classification | Clinical chemistry |
| Panel | JIN: Class I |
| Classification | 21 CFR §862.1435 Ketones (nonquantitative) test system |
| Regulation Citation | Meets limitations of exemptions 21 CFR 862.9(c)(5) |
3. Predicate Device
| K161738 | FORA ADVANCED GD40 Blood Glucose and β-Ketone Monitoring System |
|---|---|
| --------- | ----------------------------------------------------------------- |
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Intended Use 4.
The TD-4140 Smart Dongle Blood Glucose plus ß-ketone Monitoring System consists of the Smart Dongle meter, Smart Dongle blood glucose test strips, Smart Dongle ß-ketone test strips, and the Procheck mobile application as the display component of the system is intended to be used for the quantitative measurement of glucose (sugar) and ß-ketone in fresh capillary whole blood from the finger.
This system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is intended to be used by a single person and should not be shared. This system should not be used for the diagnosis of or screening for diabetes, nor for use on neonates.
Device Description 5.
The TD-4140 Smart Dongle Blood Glucose plus ß-ketone Monitoring System consists of the Smart Dongle meter, Smart Dongle blood glucose test strips, Smart Dongle 0-ketone test strips, and the Procheck mobile application as the display component of the system.
This system is compatible to iPhone series, including iPhone 4/4s, 5/5s, 6/6 plus, and iPod touch 5. These products have been designed, tested, and proven to work together as a system to produce accurate test results. The Smart Dongle meter should only be used with the Smart Dongle Blood Glucose test strips and the Smart Dongle ß-ketone test strips.
| Item | Predicate device | Proposed device |
|---|---|---|
| 510(k) no. | K161738 | - |
| Proprietary name | FORA ADVANCED GD40 Blood | |
| Glucose and β-Ketone Monitoring | ||
| System | TD-4140 Smart Dongle Blood | |
| Glucose plus β-ketone Monitoring | ||
| System | ||
| Intended use | Quantitative measurement of | |
| glucose and β-ketone in fresh | ||
| capillary whole blood from the | ||
| finger by people with diabetes at | ||
| home as an aid to monitor the | ||
| effectiveness of diabetes control. | Quantitative measurement of | |
| glucose and β-ketone in fresh | ||
| capillary whole blood from the | ||
| finger by people with diabetes at | ||
| home as an aid to monitor the | ||
| effectiveness of diabetes control. | ||
| For single person use and should not | For single person use and should not | |
| Item | Predicate device | Proposed device |
| 510(k) no. | K161738 | - |
| be shared. Not be used for the | ||
| diagnosis of or screening for | ||
| diabetes, nor for use on neonates. | be shared. Not be used for the | |
| diagnosis of or screening for | ||
| diabetes, nor for use on neonates. | ||
| Glucose | ||
| Glucose assay method | Glucose dehydrogenase | Same as predicate |
| Glucose measuring range | 20 ~ 600 mg/dL | Same as predicate |
| Sample type | Capillary finger stick | Same as predicate |
| Sample size | 0.9 uL | 1.0 uL |
| Hematocrit range | 20% ~ 70% | Same as predicate |
| Analysis time | 5 seconds | Same as predicate |
| Coding | Code Card | No coding |
| Ketone | ||
| Assay method | ẞ-hydroxybutyrate dehydrogenase | Same as predicate |
| Measuring range | 0.1 ~ 8.0 mmol/L | Same as predicate |
| Sample type | Capillary finger stick | Same as predicate |
| Ketone sample size | 1.0 uL | Same as predicate |
| Hematocrit range | 20% ~ 70% | Same as predicate |
| Analysis time | 10 seconds | Same as predicate |
| Coding | Code card | Same as predicate |
| Operating conditions | 10 °C -40 °C, 10% - 90% R.H. | 10 °C -40 °C, 10% - 85% R.H. |
| Power source | AAA x 2 | Powered by mobile platform |
| LCD | Displayed on mobile platform: | |
| iPhone 4, iPhone 4s, iPhone 5, | ||
| Display | iPhone 5s, iPhone 6, iPhone 6 plus, | |
| iPhone 6s, iPhone 6s plus and iPod | ||
| touch 5th generation | ||
| Data storage | 1000 sets | 1 set (latest result) |
| All data stored in the mobile device | ||
| Data transmission | RS-232 4 Poles | Headphone jack |
Comparison to the Predicate 6.
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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
7. Test Principle
Glucose measurement is based on electrochemical biosensor technology using the enzyme Glucose Dehydrogenase to catalyze the formation of gluconolactone from the oxidation of glucose whereby two electrons are produced. The electrical current resulting from this enzymatic reaction is measured and correlated to glucose concentration by the meter. The magnitude of the current is proportional to the
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泰博科技股份有限公司 TaiDoc Technology Corp.
concentration of glucose in the sample. The test strip is calibrated to display the equivalent of plasma glucose values to allow comparison of results with laboratory methods.
Using the same technology, B-hydroxybutyrate (β-ketone) is converted by β-hydroxybutyrate dehydrogenase and the magnitude of electrical current resulting from this enzymatic reaction is proportional to the amount of ß-hydroxybutyrate present in the sample.
The measurement result is transmitted to a compatible device via headphone jack. The App within this system is used for analysis and storage of the data for personal healthcare.
Performance Characteristics 8.
Clinical and non-clinical studies were conducted to test, verify and validate with respect to the predicate device to establish the performance of this system. The data demonstrates that this system is substantially equivalent to the predicate device.
Accuracy – blood glucose
| Results for glucose
concentration
8.0mmol/L) displaying "Lo" and "Hi" symbol respectively. The system shows a high linearity over a blood ß-Ketone range of 0.1 to 8.0 mmol/L.
Analytical specificity
Seventy-eight potential interfering substances consisting of exogenous substances originating from outside the body such as therapeutic agents or vitamins) of the most commonly used critical care drugs and endogenous substances (substances produced or originating from with the body) were chosen.
| Substance | Highest concentration
tested at which no
significant interference
is observed (mg/dL) | Substance | Highest concentration
tested at which no
significant interference is
observed (mg/dL) |
|-----------------------------|-------------------------------------------------------------------------------------------------------|----------------|-------------------------------------------------------------------------------------------------------|
| Acetylsalicylic Acid | 50 | Lactitol | 1000 |
| Acetoacetate | 20 | Lidocaine | 6 |
| Acetone | 70 | Magnesium | 5 mM |
| Acyclovir | 3.1 | Maltitol | 1000 |
| Allopurinol | 5 | Maltose | 1000 |
| Amitriptylline | 0.27 | Mannitol | 1000 |
| Amoxicillin | 12.5 | Metaproterenol | 1.81 |
| Ampicillin | 5 | Metformin HCl | 50 |
| Aspirin
(Salicylic Acid) | 60 | Metoprolol | 0.3 |
| Atenolol | 10 | Naproxen | 100 |
| Bicarbonate | 336 (40 mM) | Nifedipine | 0.17 |
| Bile Acids | 6 | Nortriptyline | 0.15 |
- . The following table lists the concentrations of substances at which no significant interference is observed.
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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
| (Cholic Acid) | |||
|---|---|---|---|
| Caffeine | 10 | Penicillin | 12 |
| Calcium | 5 mM | Phenytoin | 10 |
| Chloride | 140 mM | Piroxicam | 5 |
| Clonidine | 2 | Potassium | 10 mM |
| Creatinine | 5 | Sodium | 200 mM |
| Digoxin | 0.16 | Sorbitol | 1000 |
| Diphenhydramine | 1 | Sulfamethoxazole | 120 |
| Enalapril | 0.15 | Sulfate | 5 mM |
| Erythromycin | 20 | Terfenadine | 0.45 |
| Ephedrine Hcl | 60 | Tetracycline | 4 |
| Erythromycin | 20 | Theophylline | 25 |
| Estrone | 0.1 | Tolbutamide | 64 |
| Famotidine | 0.13 | Total Protein | |
| (gamma-Globulin) | 12000 | ||
| Fluoxetine | 0.8 | Urea | 600 |
| Fructose | 1000 | Vancomycin | 25 |
| Furosemide | 2 | Verapamil | 0.45 |
| Glyburide | 1.07 | Vitamin E | 20 |
| Ibuprofen | 55 | Warfarin | 2 |
| Isomalt | 1000 | Xylitol | 1000 |
| Lactose | 1000 | Xylose | 1000 |
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泰博科技股份有限公司 TaiDoc Technology Corp.
- The following table lists the concentrations of substances at which interference was greater than ● ±10%.
| Substance | Lowest Concentration
above which
interference >10% is
observed (mg/dL) | Substance | Lowest Concentration
above which interference
10% is observed
(mg/dL) |
|---------------|---------------------------------------------------------------------------------|-----------------------------------|---------------------------------------------------------------------------------|
| Captopril | >500 | Unconjugated bilirubin | >20 |
| Ascorbic acid | > 4 | Cholesterol | >500 |
| Dopamine | > 0.09 | Triglycerides
(Lipemic Sample) | >1500 |
| Levo – Dopa | > 0.6 | Galactose | >13.87 mmol/L |
| Gentisic Acid | >1.8 | Methyl-DOPA | >59.18 |
| Paracetamol | >25 | Tolazamide | > 321 |
| Uric acid | >24 | N-Acetylcysteine | >0.038 |
9. Conclusion
Based on the information provided in this submission, the TD-4140 Smart Dongle Blood Glucose plus β-ketone Monitoring System is substantially equivalent to the predicate device, FORA ADVANCED GD40 Blood Glucose and ß-Ketone Monitoring System (K161738).