(116 days)
No
The summary describes a standard blood glucose monitoring system and does not mention any AI or ML components.
No
The device is a monitoring system that measures glucose levels, which aids in monitoring diabetes control, but it does not treat or cure the condition, thus it is not therapeutic.
No
The "Intended Use / Indications for Use" 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's for the "quantitative measurement of glucose in fresh capillary whole blood". This involves testing a biological sample (blood) outside of the body to obtain diagnostic information (glucose levels).
- 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.
- Function: The device measures a specific analyte (glucose) in a biological fluid (blood) to aid in monitoring a medical condition (diabetes). This is a core function of an IVD.
While it's not intended for diagnosis or screening, its purpose of monitoring diabetes control through the analysis of blood samples clearly places it within the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The FORA G30a Blood Glucose Monitoring System is 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 G30a Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
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 G30a test strips and control solutions with the FORA G30a Blood Glucose Monitoring System.
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)
FORA G30a blood glucose monitoring system has the same performance characteristics as the predicate device.
A comparison of system accuracy performance demonstrated that the FORA G30a blood glucose monitoring system and the currently marketed FORA G30 Blood Glucose Monitoring System (cleared under K090187) are substantially equivalent.
Software verification and validation testing confirmed that the performance, safety and effectiveness of the FORA G30a blood glucose monitoring system is 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.
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Section 11. 510(k) Summary
510(K) SUMMARY
JUL -- 9 2010
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
KUDO732 The Assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________
-
- Submitter's Identification: TaiDoc Technology Corporation 3F, 5F, 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 3F, 5F, No.127, Wugong 2nd Rd., Wugu Township, Taipei County, 248, Taiwan
Date of submission: March 12, 2010
-
- Device name:
Proprietary name: FORA G30a blood glucose monitoring system
- Device name:
Regulatory information:
- A. Regulation section: 21 CFR 862.1345 Glucose Test System
- B. Classification: Class II
- C. Product Code: CGA, Glucose Oxidase, Glucose NBW, System, Test, Blood Glucose, Over The Counter D. Panel: Chemistry (75)
1
-
- Intended Use:
The FORA G30a Blood Glucose Monitoring System is 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.
- Intended Use:
The alternative site testing in the FORA G30a Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
-
- 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 G30a test strips and control solutions with the FORA G30a Blood Glucose Monitoring System.
- Device Description:
Substantial Equivalence Information:
A. Predicate device name: FORA G30 Blood Glucose Monitoring System
B. Predicate K number: K090187
C. Comparison with predicate:
The modified FORA G30a blood glucose monitoring system has the following similarities to the predicate device:
- 미 same operating principle,
- same fundamental scientific technology, l
- . incorporate the same basic circuit design,
- incorporate the same materials,
- 1 same shelf life
- packaged using the same materials, and
- Manufactured by the same process.
2
The modifications encompass:
- A modification in the software of the glucose meter 행
- Labeling change due to the software modification l
-
- Test Principle:
The detection and measurement of glucose in blood is by an electrochemical biosensor technology using glucose oxidase.
-
- Performance Characteristics:
FORA G30a blood glucose monitoring system has the same performance characteristics as the predicate device.
- Performance Characteristics:
A comparison of system accuracy performance demonstrated that the FORA G30a blood glucose monitoring system and the currently marketed FORA G30 Blood Glucose Monitoring System (cleared under K090187) are substantially equivalent.
Software verification and validation testing confirmed that the performance, safety and effectiveness of the FORA G30a blood glucose monitoring system is equivalent to the predicate device.
-
- Conclusion:
Based on the information provided in this submission, the FORA G30a blood glucose monitoring system is substantially equivalent to the predicate FORA G30 Blood Glucose Monitoring System.
- Conclusion:
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a stylized eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
TaiDoc Technology Corporation c/o Nicky Pan Regulatory Affairs Specialist 3F, 5F, No. 127, Wugong 2nd Rd Wugu Township Taipei County, China (Taiwan) 248
JUL 0 9 2010
Re: K100732
Trade name: FORA G30a Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA Dated: June 10, 2010 Received: June 10, 2010
Dear Nicky 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 approval of a proman 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 arrouning your 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 yours,
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