(143 days)
Not Found
No
The summary describes a standard blood glucose monitoring system and does not mention any AI or ML capabilities.
No.
This device is for monitoring blood glucose levels, which aids in managing diabetes, but it does not directly treat or cure the condition.
No
Explanation: The "Intended Use / Indications for Use" section explicitly states, "It is not intended for the diagnosis of or screening for diabetes mellitus". While it aids in monitoring, it's not a diagnostic tool according to its own description.
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 biological sample (blood) outside of the body to obtain a diagnostic result (glucose level).
- 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.
- Regulatory Context: The mention of a predicate device with a K number (K091898) indicates that this device has gone through the FDA's 510(k) clearance process, which is the regulatory pathway for many IVD devices.
Therefore, based on the provided information, the FORA G90 Perform Blood Glucose Monitoring System clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The FORA G90 Perform 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 G90 Perform Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
Product codes (comma separated list FDA assigned to the subject device)
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 G90 Perform test strips and control solutions with the FORA G90 Perform 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)
A comparison of system accuracy performance demonstrated that the FORA G90 Perform blood glucose monitoring system and the currently marketed FORA G90/TD-4234 Blood Glucose Monitoring System (cleared under K091898) arc substantially equivalent.
Software verification and validation testing confirmed that the performance, safety and effectiveness of the FORA G90 Perform blood glucose monitoring system is equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
0
Attachment 4. 510(k) Summary
JUL--9 2010
1 j {
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:
-
- 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: 02/12/2010
-
- Device name:
Proprietary name: FORA G90 Perform Blood Glucose Monitoring System
- Device name:
Regulatory information:
- Regulation section: 21 CFR 862.1345 Glucose Test System A.
- B. Classification: Class II
C. Product Code: CGA, Glucose Oxidase, Glucose NBW, System, Test, Blood Glucose, Over The Counter D. Panel: Chemistry (75)
1
3. Intended Use:
The FORA G90 Perform 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 G90 Perform Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
4. 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 G90 Perform test strips and control solutions with the FORA G90 Perform Blood Glucose Monitoring System.
Substantial Equivalence Information:
A. Predicate device name:
FORA G90/U-RIGHT TD-4234 Blood Glucose Monitoring System
B. Predicate K number: K091898
C. Comparison with predicate:
The modified FORA G90 blood glucose monitoring system has the following similarities to the predicate device:
- 비 same operating principle,
- . same fundamental scientific technology,
● incorporate the same basic circuit design.
- I incorporate the same materials,
- same shelf life
packaged using the same materials, and
Manufactured by the same process.
A4-2 of 3
2
The modifications encompass:
- 배 Software modification to no-coding
- I Addition of "no-coding" phrase on the labeling
- Software modification to use mg/dL as the preset measurement. ●
5. Test Principle:
The detection and measurement of glucose in blood is by an electrochemical biosensor technology using glucose oxidase.
-
- Performance Characteristics:
FORA G90 Perform 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 G90 Perform blood glucose monitoring system and the currently marketed FORA G90/TD-4234 Blood Glucose Monitoring System (cleared under K091898) arc substantially equivalent.
Software verification and validation testing confirmed that the performance, safety and effectiveness of the FORA G90 Perform blood glucose monitoring system is equivalent to the predicate device.
7. Conclusion:
Based on the information provided in this submission, the FORA G90 Perform blood glucose monitoring system is substantially equivalent to the predicate FORA G90/TD-4234 Blood Glucose Monitoring System.
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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a bold, sans-serif font and is aligned to the left. There is a logo to the left of the text, but it is not clear what the logo is.
Public Health Service
TaiDoc Technology Corporation c/o Nicky Pan Regulatory Affairs Specialist 3F, 5F, No. 127, Wugong 2nd Rd Wugu Township Taipei County, China (Taiwan) 248
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
JUL 0 9 2010
Re: K100405
Trade name: FORA G90 Perform 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 22, 2010 Received: June 30, 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 device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, fisting 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
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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
5
Indications for Use Form
510(k) Number (if known): K100405
Device Name: FORA G90 Perform Blood Glucose Monitoring System
Indications for Use:
The FORA G90 Perform 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 G90 Perform Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
Prescription Use X (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 OF NEEDED)
AND/OR
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K/DO 405
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