(79 days)
No
The summary describes a standard blood glucose monitoring system and does not mention any AI or ML capabilities.
No
This device is a blood glucose monitoring system, intended for measurement to aid in monitoring diabetes control, not for treating or curing a medical condition.
No
The "Intended Use / Indications for Use" section explicitly states, "It is not intended for the diagnosis of or screening for diabetes mellitus."
No
The device description explicitly states the system consists of a meter, test strips, and control solutions, which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is for the "quantitative measurement of glucose in fresh capillary whole blood". This involves testing a sample taken from the body (in vitro) to provide diagnostic information (monitoring the effectiveness of diabetes control).
- Device Description: The system consists of a meter, test strips, and control solutions, which are typical components of an in vitro diagnostic device used for chemical analysis of biological samples.
- Nature of the Test: Measuring glucose levels in blood is a classic example of an in vitro diagnostic test.
The definition of an IVD generally includes devices intended for use in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly fits that description.
N/A
Intended Use / Indications for Use
This system is intended for use outside the body (in vitro diagnostic use only). It is used for the quantitative measurement of glucose in fresh capillary whole blood samples taken from the palm, forearm, upper arm, calf, thigh, or fingers. It is not intended for the diagnosis of or screening for diabetes mellitus, or for use on neonates.
This system provides you with plasma equivalent results.
Product codes
CGA, NBW
Device Description
The system consists of three main products: the meter, test strips, and control solutions. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. Use only FORA G71a / TD-4274 test strips and control solutions with the FORA G71a Blood Glucose Monitoring System / TD-4274 Blood Glucose Monitoring System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fresh capillary whole blood samples taken from the palm, forearm, upper arm, calf, thigh, or fingers.
Indicated Patient Age Range
It is not intended for use on neonates.
Intended User / Care Setting
It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program.
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)
A comparison of system accuracy performance demonstrated that the FORA G71a blood glucose monitoring system / TD-4274 Blood Glucose Monitoring System and the currently marketed FORA G30/TD-4241 Blood Glucose Monitoring System are substantially equivalent.
Software verification and validation testing confirmed that the performance, safety and effectiveness of the FORA G71a blood glucose monitoring system / TD-4274 Blood Glucose Monitoring Systems are equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
Section 11. 510(k) Summary
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: K093712
-
- Submitter's Identification: TaiDoc Technology Corporation 6F, No.127, Wugong 2nd Rd., Wugu Township, Taipei County, 248, Taiwan
Correspondence: Nicky Pan Regulatory Affairs Specialist Tel: +886-2-6625-8188 #1196 Fax: +886-2-6625-0288 Email: nicky@taidoc.com.tw
- Submitter's Identification: TaiDoc Technology Corporation 6F, No.127, Wugong 2nd Rd., Wugu Township, Taipei County, 248, Taiwan
Date of submission: 11/30/2009
-
- Device name:
Proprietary name: FORA G71a blood glucose monitoring system TD-4274 blood glucose monitoring system
- Device name:
Regulatory information:
- A. Regulation section: 21 CFR 862.1345 Glucose Test System
- B. Classification: Class II
- Product Code: C. CGA, Glucose Oxidase, Glucose
- NBW, System, Test, Blood Glucose, Over The Counter
- D. Panel: Chemistry (75)
1
3. Intended Use:
This system is intended for use outside the body (in vitro diagnostic use only). It is used for the quantitative measurement of glucose in fresh capillary whole blood samples taken from the palm, forearm, upper arm, calf, thigh, or fingers. It is not intended for the diagnosis of or screening for diabetes mellitus, or for use on neonates.
This system provides you with plasma equivalent results.
-
- Device Description:
The system consists of three main products: the meter, test strips, and control solutions. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. Use only FORA G71a / TD-4274 test strips and control solutions with the FORA G71a Blood Glucose Monitoring System / TD-4274 Blood Glucose Monitoring System.
- Device Description:
5. Substantial Equivalence Information:
Predicate device name: A.
FORA G30/TD-4241 Blood Glucose Monitoring System
- B. Predicate K number: K090187
- Comparison with predicate: C.
The modified FORA G71a blood glucose monitoring system / TD-4274 Blood Glucose Monitoring Systems have the following similarities to the predicate device:
- same operating principle.
- same fundamental scientific technology,
- incorporate the same basic circuit design.
- 그 incorporate the same materials.
- 1 same shelf life
- 1 packaged using the same materials, and
- Manufactured by the same process.
2
The modifications encompass:
- . A modification in the software of the glucose meter
- . Modification in the physical appearance
- 일 Engineering modifications
- 1 Labeling change due to the software modification
-
- Test Principle:
The detection and measurement of glucose in blood is by an electrochemical biosensor technology using glucose oxidase.
-
- Performance Characteristics:
FORA G71a blood glucose monitoring system / TD-4274 Blood Glucose Monitoring System have the same performance characteristics as the predicate device.
- Performance Characteristics:
A comparison of system accuracy performance demonstrated that the FORA G71a blood glucose monitoring system / TD-4274 Blood Glucose Monitoring System and the currently marketed FORA G30/TD-4241 Blood Glucose Monitoring System are substantially equivalent.
Software verification and validation testing confirmed that the performance, safety and effectiveness of the FORA G71a blood glucose monitoring system / TD-4274 Blood Glucose Monitoring Systems are equivalent to the predicate device.
-
- Conclusion:
Based on the information provided in this submission, the FORA G71a blood glucose monitoring system / TD-4274 Blood Glucose Monitoring System are substantially equivalent to the predicate FORA G30/TD-4241 Blood Glucose Monitoring System.
- Conclusion:
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized symbol. The symbol consists of three abstract human figures. The figures are connected and appear to be in motion.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Taidoc Technology Corporation c/o Ms. Nicky Pan 6f, No. 127, Wugong 2nd Rd, Wugu Township Taipei County, China (Taiwan) 248
FEB 1 9 2010
Re: K093712
Trade/Device Name: Fora G71a Blood Glucose Monitoring System, TD-4274 Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system. Regulatory Class: II Product Code: NBW, CGA Dated: December 3, 2009 Received: January 20, 2010
Dear: Ms. Pan:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2
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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Cfa
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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Section 8. Indications for Use
Indications for Use
K093712 510(k) Number:
Device Name: FORA G71a Blood Glucose Monitoring System/TD-4274 Blood Glucose Monitoring System
Indications for Use:
The FORA G71a Blood Glucose Monitoring System/TD-4274 Blood Glucose Monitoring System are intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The alternative site testing in the FORA G71a Blood Glucose Monitoring System /TD-4274 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
And/Or
Prescription Use (21 CFR Part 801 Subpart D)
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic. Device Evaluation and Safety (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k)
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