(86 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related technologies. The device description and performance study sections are also not found, which would be likely places to describe such technologies if present.
No
This device is a blood glucose monitoring system, which is used for measurement and monitoring, not for treating a disease or condition.
No
The text explicitly states: "It is not intended for the diagnosis of or screening for diabetes mellitus".
No
The description clearly states it is a "Blood Glucose Monitoring System" which implies hardware components (like a meter and test strips) are involved in the quantitative measurement of glucose. The summary does not mention it being solely 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". This involves testing a biological sample (blood) outside of the body (in vitro) to obtain diagnostic information (glucose levels).
- Purpose: The purpose is to aid in "monitoring the effectiveness of diabetes control program". This is a diagnostic purpose, even though it's not for initial diagnosis or screening.
The definition of an IVD generally includes devices used to examine specimens derived from the human body to provide information for diagnostic purposes. This device clearly fits that description.
N/A
Intended Use / Indications for Use
The FORA G90 / U-Right TD-4234 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, nor is it intended for use on newborns.
The alternative site testing in this system can be used only during steady-state blood glucose conditions.
Product codes
NBW, CGA
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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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
It is not intended for use on newborns.
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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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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Image /page/0/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines.
SEP 18 2009 .
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
TaiDoc Technology Corporation c/o Ms. Erica Li 6F, No. 127, Wugong 2nd Rd., Wugu Township Taipei County, 24888 Taiwan, R.O.C.
Re: K091898
Trade name: FORA G90 Blood Glucose Monitoring System, U-Right TD-4234 Blood Glucose Monitoring System
Regulation Number: 21 CFR 862.1345
Regulation Name: Glucose Test System
Regulatory Class: Class II
Product Code: NBW, CGA
Dated: August 14, 2009
Received: August 18, 2009
Dear Ms. Li:
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 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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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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 (240) 276-0450. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)). please contact the Division of Surveillance Systems at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sincerely yours,
Courthey C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
Attachment 2-1
Indications for Use
510(k) Number:
Ka1898
Device Name:
FORA G90 / U-Right TD-4234 Blood Glucose Monitoring System
Indications for Use:
The FORA G90 / U-Right TD-4234 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, nor is it intended for use on newborns.
The alternative site testing in this system can be used only during steady-state blood glucose conditions.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use ਮ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CORH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Page 1 of
Office of In Vitro Diagnos Descr Evaluation and S
500K K-091898