(787 days)
No
The 510(k) summary describes a standard glucose, ketone, and cholesterol monitoring system based on test strips and a meter. There is no mention of AI, ML, or any advanced computational analysis of the data beyond basic measurement and display. The performance studies focus on accuracy, precision, and user evaluation, not on the performance of any AI/ML algorithm.
No.
This device is an in vitro diagnostic (IVD) device used for monitoring glucose, ß-ketone, and cholesterol levels, not for providing therapy or treatment.
Yes
The system is described as being for "in vitro diagnostic use" and indicates that cholesterol measurements "are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders."
No
The device description explicitly lists hardware components including a meter and test strips, in addition to mentioning software validation.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "It is only for use outside the body (in vitro diagnostic use)."
- Measurement of Analytes in Biological Samples: The system is intended for the quantitative measurement of glucose, beta-hydroxybutyrate (ß-ketone), and cholesterol in fresh capillary whole blood from the finger. This is a classic characteristic of an in vitro diagnostic device, as it analyzes biological samples outside of the body to provide diagnostic information.
- Aid in Diagnosis and Monitoring: The intended use describes how the measurements are used as an aid to monitor the effectiveness of a diabetes control program (glucose and ß-ketone) and in the diagnosis and treatment of disorders involving excess cholesterol (cholesterol). This aligns with the purpose of IVDs, which are used to provide information for diagnosis, monitoring, or screening.
N/A
Intended Use / Indications for Use
The FORA ADVANCED GD40 Glucose, β-Ketone and Cholesterol Monitoring System consists of the FORA ADVANCED GD40 meter, the FORA ADVANCED GD40 Blood Glucose strips, the FORA ADVANCED GD40 β-Ketone strips, and the FORA ADVANCED GD40 Total Cholesterol strips.
The FORA ADVANCED GD40 Glucose, β-Ketone and Cholesterol Monitoring System is intended for the quantitative measurement of glucose, beta-hydroxybutyrate (β-ketone), and cholesterol in fresh capillary whole blood from the finger. This system is intended for single-patient home use and should not be shared. This device is intended for use by patients with diabetes. It is only for use outside the body (in vitro diagnostic use).
Glucose and β-ketone measurements are used as an aid to monitor the effectiveness of a diabetes control program. Glucose measurements should not be used for the diagnosis of or screening for diabetes.
Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Cholesterol should be measured at the frequency recommended by your healthcare provider.
Product codes
NBW, JIN, CHH
Device Description
FORA ADVANCED GD40 Glucose, β-Ketone and Cholesterol Monitoring System includes the FORA ADVANCED GD40 Meter, analyte-specific test strips (FORA ADVANCED GD40 Blood Glucose Test Strips, FORA ADVANCED GD40 Blood Cholesterol Test Strips, and FORA ADVANCED GD40 Blood Ketone Test Strips) and control solutions (FORA Glucose Control Solutions, B-Ketone Control Solutions and Total Cholesterol Control Solutions).
The glucose/β-ketone test strips and control solutions utilized in the FORA ADVANCED GD40 Glucose, β-Ketone and Cholesterol Monitoring System are the same as the predicate, FORA ADVANCED GD40 Blood Glucose and β-Ketone Monitoring System (K161738).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
finger (capillary whole blood)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
single-patient home use
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
Non-clinical and clinical studies were conducted to test, verify and validate the performance of the proposed device. 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 FORA ADVANCED GD40 Glucose, β-Ketone and Cholesterol Monitoring 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
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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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June 16, 2022
TaiDoc Technology Corporation Jacky Chou Director of Regulatory Affairs B1-7F, No. 127, Wugong 2nd Rd., Wugu District New Taipei City, 24888 Taiwan
Re: K201037
Trade/Device Name: FORA ADVANCED GD40 Glucose, β-Ketone and Cholesterol Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, JIN, CHH Dated: February 24, 2022 Received: March 1, 2022
Dear Jacky Chou:
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.
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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) 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 (QS) 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 medical devices and radiation-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.
Marianela Perez-Torres, Ph.D. Deputy 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) K201037
Device Name
FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System
Indications for Use (Describe)
The FORA ADVANCED GD40 Glucose, p-Ketone and Cholesterol Monitoring System consists of the FORA ADVANCED GD40 meter, the FORA ADVANCED GD40 Blood Glucose strips, the FORA ADVANCED GD40 B-Ketone strips, and the FORA ADVANCED GD40 Total Cholesterol strips.
The FORA ADVANCED GD40 Glucose, B-Ketone and Cholesterol Monitoring System is intended for the quantitative measurement of glucose, beta-hydroxybutyrate (8-ketone), and cholesterol in fresh capillary whole blood from the finger. This system is intended for single-patient home use and should not be intended for use by patients with diabetes. It is only for use outside the body (in vitro diagnostic use).
Glucose and {}-ketone measurements are used as an aid to monitor the effectiveness of a diabetes control program. Glucose measurements should not be used for the diagnosis of or screening for diabetes.
Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Cholesterol should be measured at the frequency recommended by your healthcare provider.
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | |
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510(k) Summary
Submission Number: K201037
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
A. Submitter Information
| Company Name: | TaiDoc Technology Corporation |
|---|---|
| Contact Person: | Jacky Chou |
| Title: | Director of Regulatory Affairs |
| Address: | B1-7F, No. 127, Wugong 2nd Rd., Wugu District, New Taipei |
| City, 24888, Taiwan | |
| Phone: | +886-2-6625-8188 |
| Fax: | +886-2-6625-0288 |
| E-mail: | jacky.chou@taidoc.com.tw |
| Prepared Date: | June 16th, 2022 |
B. Regulatory information:
| Proprietary Name: | FORA ADVANCED GD40 Glucose, β-Ketone and Cholesterol
Monitoring System |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code: | NBW - Blood Glucose Test System, Over-the-Counter
JIN - nitroprusside, ketones (urinary, non-quant.)
CHH - enzymatic esterase--oxidase, cholesterol |
| Classification Panel: | 75, Clinical chemistry |
|---|---|
| Classification: | Class II (glucose test) |
| Class I, meets the limitations of exemption 21 CFR 862.9(c)(5) (β- | |
| ketone test) | |
| Class I, meets the limitations of exemption 21 CFR 862.9(c)(4) | |
| (cholesterol test) |
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| Regulation Citation: | 21 CFR 862.1345, Glucose test system |
|---|---|
| 21 CFR 862.1435 Ketones (nonquantitative) test system | |
| 21 CFR 862.1175 Cholesterol (total) test system. |
C. Predicate Devices
FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems (K161738)
Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System (K163406)
D. Indications for Use
The FORA ADVANCED GD40 Glucose, β-Ketone and Cholesterol Monitoring System consists of the FORA ADVANCED GD40 meter, the FORA ADVANCED GD40 Blood Glucose strips, the FORA ADVANCED GD40 ß-Ketone strips, and the FORA ADVANCED GD40 Total Cholesterol strips.
The FORA ADVANCED GD40 Glucose, β-Ketone and Cholesterol Monitoring System is intended for the quantitative measurement of glucose, betahydroxybutyrate (β-ketone), and cholesterol in fresh capillary whole blood from the finger. This system is intended for single-patient home use and should not be shared. This device is intended for use by patients with diabetes. It is only for use outside the body (in vitro diagnostic use).
Glucose and ß-ketone measurements are used as an aid to monitor the effectiveness of a diabetes control program. Glucose measurements should not be used for the diagnosis of or screening for diabetes.
Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Cholesterol should be measured at the frequency recommended by your healthcare provider.
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E. Device Description:
FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System includes the FORA ADVANCED GD40 Meter, analyte-specific test strips (FORA ADVANCED GD40 Blood Glucose Test Strips, FORA ADVANCED GD40 Blood Cholesterol Test Strips, and FORA ADVANCED GD40 Blood Ketone Test Strips) and control solutions (FORA Glucose Control Solutions, B-Ketone Control Solutions and Total Cholesterol Control Solutions).
The glucose/9-ketone test strips and control solutions utilized in the FORA ADVANCED GD40 Glucose, B-Ketone and Cholesterol Monitoring System are the same as the predicate, FORA ADVANCED GD40 Blood Glucose and ß-Ketone Monitoring System (K161738).
F. 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 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, Bhydroxybutyrate (B-ketone) is converted by ß-hydroxybutyrate dehydrogenase and the magnitude of electrical current resulting from this enzymatic reaction is proportional to the amount of B-hydroxybutyrate present in the sample; Cholesterol esters in serum are completely hydrolyzed by cholesterol esterase to free cholesterol and free fatty acids, whereby liberated cholesterol, plus any endogenous free cholesterol, are oxidized by cholesterol oxidase and the magnitude of electrical current resulting from this enzymatic reaction is proportional to the amount of cholesterol present in the sample.
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G. Summary of Technological Characteristics and Comparison to the Predicate
The similarities and differences between the predicate and proposed device are summarized in Table 1 and Table 2.
| Similarities and Differences: System (Test and Instrument) for blood Glucose and Ketone | ||
|---|---|---|
| Feature or | ||
| Characteristic | Predicate: FORA ADVANCED | |
| GD40 Blood Glucose and β-Ketone | ||
| Monitoring System (K161738) | Candidate: FORA ADVANCED | |
| GD40 Glucose, β-Ketone and | ||
| Cholesterol Monitoring System | ||
| Intended Use | It is intended for the quantitative | |
| measurement of glucose in fresh | ||
| capillary whole blood from the | ||
| finger, and for the quantitative | ||
| measurement of β-ketone (beta- | ||
| hydroxybutyrate) in fresh capillary | ||
| whole blood from the finger. The | ||
| FORA ADVANCED GD40 is | ||
| intended for in vitro diagnostic use | ||
| and is intended for single-patient use | ||
| as an aid to monitor the effectiveness | ||
| of a diabetes control program. The | ||
| system should not be used for the | ||
| diagnosis of or screening for | ||
| diabetes. | Same | |
| Setting to be used | Over-the-counter Home use | Same |
| Test Range | 20 – 600 mg/dL | Same |
| Sample Type | Fingertip Capillary whole blood | Same |
| Sample Volume | 0.9 μl | Same |
| Test Time | 5 sec | Same |
| Calibration | Automatic | Same |
| Operating | ||
| Principle | Enzymatic | Same |
| Data storage | 1000 Results with Date/Time | Same |
| Weight | 71 g | Same |
| Analytes | Glucose and β-Ketone | Glucose, β-Ketone, and Cholesterol |
Table 1: Similarities and differences between the predicate and proposed device (Glucose and Ketone)
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| Table 2: Similarities and differences between the predicate and proposed device | |||||
|---|---|---|---|---|---|
| (Cholesterol) |
| Similarities and Differences: System (Test and Instrument) for blood Cholesterol | ||
|---|---|---|
| Feature or | ||
| Characteristic | Predicate: Mission Cholesterol | |
| Monitoring System (K163406) | Candidate: FORA ADVANCED | |
| GD40 Glucose, \u03b2-Ketone and | ||
| Cholesterol Monitoring System | ||
| Intended Use | It is intended to be used in the | |
| diagnosis and treatment of disorders | ||
| involving excess cholesterol in the | ||
| blood and lipid and lipoprotein | ||
| metabolism disorders. Cholesterol | ||
| should be measured at the frequency | ||
| recommended by the healthcare | ||
| provider. | Same | |
| Setting to be used | Over-the-counter Home use and | |
| Prescription use | Over-the-counter Home use | |
| Test Range | $100 - 400 mg/dL$ | Same |
| Sample Type | Fingertip Capillary whole blood | Same |
| Sample Volume | $10 \mu l$ | $5 \mu l$ |
| Test Time |