(155 days)
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No
The summary describes a standard blood glucose and blood pressure monitoring system with no mention of AI or ML capabilities.
No.
The device is described as a monitoring system for glucose, blood pressure, and pulse rate, which aids in monitoring the effectiveness of a diabetes control program, but it does not treat or cure any condition.
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 and not for diagnosis.
No
The device description explicitly mentions a "Blood Glucose plus Blood Pressure Monitoring System" and describes the use of an "inflatable cuff wrapped around the arm" for blood pressure measurement. These are hardware components, indicating it is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- It measures glucose in fresh capillary whole blood. This is a classic example of an in vitro diagnostic test, as it involves analyzing a biological sample (blood) outside of the body to obtain diagnostic information (glucose levels).
- The intended use explicitly states "quantitative measurement of glucose in fresh capillary whole blood". This directly aligns with the definition of an IVD.
While the device also measures blood pressure and pulse rate (which are not IVD functions), the glucose measurement component makes it fall under the IVD category.
N/A
Intended Use / Indications for Use
The FORA D20/TD-3263 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, or for testing on neonates.
The alternative site testing in this 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 at home. The blood pressure is measured by using a technique in which an inflatable cuff is wrapped around the arm. The cuff circumference is limited to 9.4" ~ 13.8".
This meter has some speaking functions but is not intended for use by the visually impaired
Product codes
NBW, CGA, DXN
Device Description
The FORA D20/TD-3263 Blood Glucose plus Blood Pressure Monitoring System is a device intended for measuring glucose in fresh capillary whole blood and for non-invasively measuring systolic and diastolic blood pressure and pulse rate. The blood glucose measurement can be performed using blood from the finger and alternative sites (palm, forearm, upper-arm, calf, and thigh). The blood pressure measurement is done by wrapping an inflatable cuff around the arm. The device also includes some speaking functions.
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
Glucose measurement: finger, palm, forearm, upper-arm, calf, thigh.
Blood pressure measurement: arm.
Indicated Patient Age Range
Adult individual (for blood pressure measurement). Not intended for testing on neonates (for glucose 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): 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.
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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.
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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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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight. The symbol is composed of three curved lines that create a sense of movement and dynamism.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
TaiDoc Technology Corporation c/o Ms. Erica Li Management Representative 6F, No. 127, Wugong 2nd Road WUGU Township Taipei County, China (Taiwan) 248
NOV 2 0 2009
Re: K091814
Trade name: FORA D20/TD-3263 Blood Glucose Plus Blood Pressure Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA, DXN Dated: November 6, 2009 Received: November 9, 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 (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/ResourcesforYou/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
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Attachment 6
Indications for Use
510(k) Number (if known):
Device Name:
FORA D20/TD-3263 Blood Glucose plus Blood Pressure Monitoring System Indications for Use:
The FORA D20/TD-3263 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, or for testing on neonates.
The alternative site testing in this 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 at home. The blood pressure is measured by using a technique in which an inflatable cuff is wrapped around the arm. The cuff circumference is limited to 9.4" ~ 13.8".
This meter has some speaking functions but is not intended for use by the visually impaired
AND/OR Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Disision Sign-off Office of In Vitro Diagnostic Devices Evaluation and Safety Roy1814 510(k) Page 1 of 1