(84 days)
Not Found
No
The summary describes a standard blood glucose monitoring system with a speaking function for visually impaired users. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as a "Blood Glucose Monitoring System" intended for quantitative measurement of glucose and is used as an "aid in monitoring the effectiveness of diabetes control program." It is not intended for treatment or therapy.
No
The "Intended Use" section explicitly states: "It is not intended for the diagnosis of or screening for diabetes mellitus". While it measures glucose, its use is for monitoring effectiveness of diabetes control programs, not initiation of diagnosis.
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 a diagnostic measurement.
- Device Description: The system consists of a meter, test strips, and control solutions, which are typical components of an in vitro diagnostic system used for chemical analysis of biological samples.
- Regulatory Context: Blood glucose monitoring systems are generally classified as IVDs by regulatory bodies like the FDA because they are used to measure a substance in a biological sample to aid in the management of a medical condition (diabetes).
While it's not intended for diagnosis or screening, its use in monitoring the effectiveness of a diabetes control program by measuring glucose in blood clearly falls under the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The FORA V20 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 V20 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
The FORA V20 Blood Glucose Monitoring System contains a speaking functionality which provides step by step instructions to aid visually impaired persons.
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 V20 test strips and control solutions with the FORA V20 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 from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the 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 V20 Blood Glucose Monitoring System and the currently marketed FORA TD-4245 Blood Glucose Monitoring System are substantially equivalent.
Software verification and validation testing confirmed that the performance, safety and effectiveness of the FORA V20 Blood Glucose Monitoring Systems arc 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 3. 510(k) Summary
MAY 1 1 2010
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: K100406
-
- 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 V20 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 V20 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 V20 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
The FORA V20 Blood Glucose Monitoring System contains a speaking functionality which provides step by step instructions to aid visually impaired persons.
-
- 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 V20 test strips and control solutions with the FORA V20 Blood Glucose Monitoring System.
- Device Description:
-
- Substantial Equivalence Information:
Predicate device name: A. FORA TD-4245 Blood Glucose Monitoring System
- Substantial Equivalence Information:
B. Predicate K number: K083664
C. Comparison with predicate:
The modified FORA V20 Blood Glucose Monitoring Systems has the following similarities to the predicate device:
- same operating principle,
- I same fundamental scientific technology,
- . incorporate the same basic circuit design,
- incorporate the same materials,
- 1 same shelf life
A3-2 of 3
2
- packaged using the same materials, and
- manufactured by the same process.
The modifications encompass:
- Software modification to no-coding
- I Addition of "no-coding" phrase on the labeling
- Addition of speaking function in Spanish ■
- ... Software modification to use mg/dL as the preset measurement.
-
- Test Principle:
The detection and measurement of glucose in blood is by an electrochemical biosensor technology using glucose oxidase.
-
- Performance Characteristics:
FORA V20 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 V20 Blood Glucose Monitoring System and the currently marketed FORA TD-4245 Blood Glucose Monitoring System are substantially equivalent.
Software verification and validation testing confirmed that the performance, safety and effectiveness of the FORA V20 Blood Glucose Monitoring Systems arc equivalent to the predicate device.
-
- Conclusion:
Based on the information provided in this submission, the FORA V20 Blood Glucose Monitoring System is substantially equivalent to the predicate FORA TD-4245 Blood Glucose Monitoring System.
- Conclusion:
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Public Health Service
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The text is in all caps and is written in a sans-serif font. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
TaiDoc Technology Corporation c/o Nicky Pan Specialist of Regulatory Affairs 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
Hay 1 1 2010
Re: k 100406
Trade name: FORA V20 Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA Dated: April 16, 2010 Received: April 16, 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, 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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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): K100406
Device Name: FORA V20 Blood Glucose Monitoring System
Indications for Use:
The FORA V20 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 V20 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
The FORA V20 Blood Glucose Monitoring System contains a speaking functionality which provides step by step instructions to aid visually impaired persons.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign Off Office of In Vitro
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K100406
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