(37 days)
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No
The provided text describes a standard blood glucose and blood pressure monitoring system with no mention of AI or ML technologies.
No
The device is intended for monitoring blood glucose and blood pressure, which are diagnostic and monitoring functions, not direct therapeutic interventions.
No
The text explicitly states: "It is not intended for the diagnosis of or screening for diabetes mellitus". While it measures glucose and blood pressure, its intended use is for monitoring effectiveness of diabetes control and blood pressure/pulse, not for initial diagnosis.
No
The device description is not provided, but the intended use clearly describes a "Blood Glucose plus Blood Pressure Monitoring System" that involves measuring glucose in blood and blood pressure using an inflatable cuff wrapped around the wrist. These functions inherently require hardware components (glucose meter, blood pressure cuff, sensor, etc.) and are not solely software-based.
Yes, based on the provided information, the FORA TD-3224 Blood Glucose plus Blood Pressure Monitoring System is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The primary intended use is the "quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites...". This involves analyzing a biological sample (blood) outside of the body to obtain a diagnostic measurement (glucose level). This is a core characteristic of an in vitro diagnostic device.
- Sample Type: The device uses "fresh capillary whole blood," which is a biological specimen.
- Measurement: It performs a "quantitative measurement" of glucose, providing a numerical value related to a physiological state.
While the device also measures blood pressure, which is a non-invasive measurement and not typically considered an IVD function, the inclusion of the blood glucose measurement component clearly places it within the scope of an IVD device.
N/A
Intended Use / Indications for Use
The FORA TD-3224 Blood Glucose plus Blood Pressure 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 system can be used only during steady-state blood glucose conditions.
The system is also intended to be used to measure non-invasively the systolic and diastolic blood pressure and pulse rate of an adult individual, over age 16, at home. The blood pressure is measured by using a technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 5.25" ~ 7.75".
Product codes
CGA, NBW, DXN
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.
wrist (for blood pressure measurement)
Indicated Patient Age Range
Not intended for use on neonates.
Over age 16 for blood pressure measurement.
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
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three wing-like shapes extending upwards and to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 2 5 2008
TaiDoc Technology Corporation c/o Yuhua Chen Regulatory Affairs Specialist 6F, No. 127, Wugong 2nd Road Wugu Township, Taipei County China, Taiwan 248
Re: K081714
Trade/Devicc Name: FORA TD-3224 Blood Glucose Plus Blood Pressure Monitoring System
Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system. Regulatory Class: Class II Product Code: CGA, NBW, DXN Dated: July 16, 2008 Received: July 18, 2008
Dear Yuhua Chen:
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); 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Yéan M. Cooper, M.S., D.V.M. 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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Indications for Use
510(k) Number: K081714
Device Name: FORA TD-3224 Blood Glucose plus Blood Pressure Monitoring System
Indications for Use:
The FORA TD-3224 Blood Glucose plus Blood Pressure 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 system can be used only during steady-state blood glucose conditions.
The system is also intended to be used to measure non-invasively the systolic and diastolic blood pressure and pulse rate of an adult individual, over age 16, at home. The blood pressure is measured by using a technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 5.25" ~ 7.75".
| Prescription Use | |
|---|---|
| (21 CFR Part 801 Subpart D) |
And/Or
| Over the Counter Use | X |
|---|---|
| (21 CFR Part 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEBDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Carol C Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K081714
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