(130 days)
Not Found
No
The summary describes a standard electrochemical blood glucose monitoring system and does not mention any AI or ML components.
No.
The device measures glucose levels to aid in monitoring diabetes control, but it does not directly treat or prevent a disease.
No.
The "Intended Use / Indications for Use" section explicitly states: "They are not intended for the diagnosis of or screening for diabetes mellitus".
No
The device description explicitly states the system utilizes an electrochemical method-based meter and dry reagent biosensor (test strips), indicating the presence of hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative measurement of glucose in fresh capillary whole blood samples." This is a measurement performed in vitro (outside the body) on a biological sample.
- Device Description: The device description details the use of an "electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing." This describes the components and method used to perform the in vitro test.
- Predicate Device: The predicate device listed (CLEVER CHEK TD-4222 No-Code Blood Glucose Monitoring System) is also a blood glucose monitoring system, which are typically classified as IVDs.
The core function of the device is to analyze a biological sample (blood) outside of the body to provide diagnostic information (glucose levels), which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The FORA G72 / TD-4264 Blood Glucose Monitoring System, FORA G70 / TD-4273 Blood Glucose Monitoring System, and Ultra Trak Active Blood Glucose Monitoring System are intended for use in the quantitative measurement of glucose in fresh capillary whole blood samples from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. They are intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. They are not intended for the diagnosis of or screening for diabetes mellitus, nor for use on neonates.
The alternative site testing in above systems can be used only during steady-state blood glucose conditions.
Product codes (comma separated list FDA assigned to the subject device)
NBW, CGA
Device Description
The FORA G72 / TD-4264, FORA G70 / TD-4273, and Ultra Trak Active Blood Glucose Monitoring System are designed to quantitatively measure the concentration of glucose in fresh capillary whole blood. The test principle of system utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in whole blood and control solutions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
finger, palm, forearm, upper-arm, calf, thigh
Indicated Patient Age Range
Not intended for use on neonates.
Intended User / Care Setting
healthcare professionals and 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)
The studies of software verification and validation testing, system accuracy, and meter reliability test demonstrated that the performance of systems meets the intended use.
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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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: _________k093005
| 1. Submitter Information | |
|---|---|
| Company name | TaiDoc Technology Corporation |
| Contact person | Teling Hsu |
| Address | 6F, No. 127, Wugong 2nd Rd, |
| Wugu Township, Taipei County, | |
| 24888, Taiwan | |
| Phone | (+886-2) 6625-8188 #1176 |
| FAX | (+886-2) 6625-0288 |
| teling.hsu@taidoc.com.tw | |
| Date Prepared | September 27th, 2009 |
| 2. Name of Device | |
| Proprietary Names | 1. FORA G72 Blood Glucose Monitoring |
| System / TD-4264 Blood Glucose | |
| Monitoring System |
- FORA G70 Blood Glucose Monitoring
System / TD-4273 Blood Glucose
Monitoring System - Ultra Trak Active Blood Glucose
Monitoring System |
| Common Name | Blood Glucose Test System |
| Classification Name | Class II devices (21 CFR Section 862.1345) |
| Product Code | NBW / CGA |
| 3. Predicate Device | |
| Trade/Proprietary Name: | CLEVER CHEK TD-4222 No-Code Blood
Glucose Monitoring System |
| Common/Usual Name: | Blood Glucose Test System |
| Manufacturer | TaiDoc Technology Corporation |
| 510 (k) Number | K090185 |
| | |
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4. Device Description
The FORA G72 / TD-4264, FORA G70 / TD-4273, and Ultra Trak Active Blood Glucose Monitoring System are designed to quantitatively measure the concentration of glucose in fresh capillary whole blood. The test principle of system utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in whole blood and control solutions.
5. Intended Use
The FORA G72 / TD-4264 Blood Glucose Monitoring System, FORA G70 / TD-4273 Blood Glucose Monitoring System, and Ultra Trak Active Blood Glucose Monitoring System are intended for use in the quantitative measurement of glucose in fresh capillary whole blood samples from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. They are intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. They are not intended for the diagnosis of or screening for diabetes mellitus, nor for use on neonates.
The alternative site testing in above systems can be used only during steady-state blood glucose conditions.
6. Comparison to Predicate Device
The intended use, test principle, and operating technology of FORA G72 / TD-4264, FORA G70 / TD-4273, and Ultra Trak Active Blood Glucose Monitoring Systems are all the same as the predicate device. The only difference between the predicate and proposed devices is in engineering modification.
These systems use amperometry for blood glucose measurement. The test is based on the measurement of electrical current generated by the reaction of glucose with reagents of the test strip.
7. Performance Studies
FORA / TD-4264, FORA G70 / TD-4273, and Ultra Trak Active Blood Glucose Monitoring System has the same performance characteristics as the predicate device.
The studies of software verification and validation testing, system accuracy, and meter reliability test demonstrated that the performance of systems meets the intended use.
. 8. Conclusion
The FORA / TD-4264, FORA G70 / TD-4273, and Ultra Trak Active Blood Glucose
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Monitoring Systems demonstrate satisfactory performance and are suitable for the intended use. FORA / TD-4264, FORA G70 / TD-4273, and Ultra Trak Active Blood Glucose Monitoring Systems are substantially equivalent to the predicate device.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Taidoc Technology Corp. C/O Teling Hsu 6F, No. 127, Wugong 2nd Rd. Wugu Township Taipei County China (Taiwan) 248
FEB 5 2010
Re: K093005
Trade/Device Name: FORA G72/TD-4264 Blood Glucose Monitoring System, FORA G70/TD-4273 Blood Glucose Monitoring System, Ultra Trak Active Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA Dated: December 23, 2009 Received: January 8, 2010
Dear Teling Hsu:
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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
CA
Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): |(كَ كَ رَ ن 3
Device Name:
FORA G72 / TD-4264 Blood Glucose Monitoring System, FORA G70 / TD-4273 Blood Glucose Monitoring System, and Ultra Trak Active Blood Glucose Monitoring System
Indications for Use:
The FORA G72 / TD-4264 Blood Glucose Monitoring System, FORA G70 / TD-4273 Blood Glucose Monitoring System, and Ultra Trak Active Blood Glucose Monitoring System are intended for use in the quantitative measurement of glucose in fresh capillary whole blood samples from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. They are intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. They are not intended for the diagnosis of or screening for diabetes mellitus, nor for use on neonates.
The alternative site testing in above systems can be used only during steady-state blood glucose conditions.
AND/OR Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C Benaim
Division Sign-off Office of In Vitro Diagnostic Devices Evaluation and Safety 510(k)_K093005 Page 1 of __ 1