(529 days)
Not Found
No
The document describes a standard blood glucose and blood pressure monitoring system. There is no mention of AI, ML, or any advanced computational techniques beyond basic measurement and speaking functions. The performance studies described are standard clinical trials comparing the device to a predicate and reference methods, not AI/ML model validation.
No
The device is intended for measurement and monitoring of blood glucose and blood pressure, not for providing therapy.
No
The device is explicitly stated as "not to be used for the diagnosis of or screening for diabetes." Instead, it is intended to "monitor the effectiveness of diabetes control."
No
The device description explicitly states that the system consists of a monitor, test strip, control solution, and a pressure cuff, which are all hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The intended use section for the FORA D40d explicitly states: "This system is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control."
- Nature of the Test: The device measures glucose in blood samples. This is a test performed on a biological sample taken from the body, which is the definition of an in vitro diagnostic test.
- Intended Use: The primary intended use is to monitor blood glucose levels, which is a diagnostic aid for managing diabetes.
While the device also measures blood pressure, which is not an in vitro diagnostic test, the blood glucose monitoring component clearly falls under the definition of an IVD. The document describes a system that includes both functionalities, and the blood glucose measurement is explicitly labeled as for "in vitro diagnostic use."
N/A
Intended Use / Indications for Use
FORA D40d for single patient use
The FORA D40d Blood Glucose plus Blood Pressure Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, and upper arm. This system is intended to be used by a single person and should not be shared.
The FORA D40d Blood Glucose plus Blood Pressure Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The FORA D40d Test Strips are for use with the FORA D40d Blood Glucose plus Blood Pressure Monitoring System to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, and upper arm.
This 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 an inflatable cuff wrapped around the arm.
This system contains speaking function, but is not intended for use by the visually impaired.
FORA Wisdom D40d for multiple patients use
The FORA Wisdom D40d Blood Glucose plus Blood Pressure Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, and upper arm. This system is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. This system is only used with single-use auto-disabling lancing devices.
The FORA Wisdom D40d Blood Glucose plus Blood Pressure Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing such as the palm, forearm, and upper arm should be done only during steady - state times (when glucose is not changing rapidly).
The FORA Wisdom D40d Test Strips are for use with the FORA Wisdom D40d Blood Glucose plus Blood Pressure Monitoring System to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, and upper arm.
This 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 an inflatable cuff wrapped around the arm.
This system contains speaking function, but is not intended for use by the visually impaired.
Product codes (comma separated list FDA assigned to the subject device)
NBW, CGA, DXN
Device Description
The FORA D40d Blood Glucose plus Blood Pressure Monitoring System FORA Wisdom D40d Blood Glucose plus Blood Pressure Monitoring System consists of one monitor, test strip, control solution, and a pressure cuff. The proposed device has been designed, tested, and demonstrated to work together as a system to produce accurate blood glucose test results and blood pressure measurements.
The proposed device contains speaking function which offers step-by-step audio instructions to help users perform a glucose test or take a blood pressure measurement.
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
Fingertips, palm, forearm, upper arm
Indicated Patient Age Range
Adult individual
Intended User / Care Setting
FORA D40d: Single person, at home, by people with diabetes.
FORA Wisdom D40d: Multiple patients, professional healthcare settings.
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)
To evaluate the system accuracy of FORA D40d and FORA Wisdom D40d Blood Glucose plus Blood Pressure Monitoring System, the consumer study was performed according to ISO 15197 and other tests performed according to ANSI/AAMI SP10. Results show that the device met the requirements of ISO 15197 and ANSI/AAMI SP10, and is safe during the use. It is substantially equivalent to the predicate device with the same effectiveness and safety.
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.
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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).
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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 contains a sequence of handwritten digits and letters. The sequence appears to be 'K101926'. The characters are written in a simple, slightly irregular style, typical of handwriting.
DEC 2 0 2011
Attachment B2
510(k) Summary
| 1. Submitter Information | |
|---|---|
| Company name | TaiDoc Technology Corporation |
| Contact person | Linda Ko |
| Address | 3F, 5F, No. 127, Wugong 2nd Rd., |
| Wugu Dist., New Taipei City, | |
| 24888, Taiwan | |
| Phone | (+886-2) 6625-8188 ext.1158 |
| FAX | (+886-2) 6625-0288 |
| kolinda@taidoc.com.tw | |
| Date Prepared | July 7th, 2010 |
| 2. Name of Device | |
| Trade/Proprietary Name | FORA D40d Blood Glucose plus Blood |
| Pressure Monitoring System and FORA | |
| Wisdom D40d Blood Glucose plus | |
| Blood Pressure Monitoring System | |
| Common Names | Blood glucose and Blood Pressure test |
| system | |
| Product Code | NBW, CGA, DXN |
| Classification Panel | Clinical Chemistry (75) ; Cardiovascular |
| Regulations | Class II |
- Predicate Device Trade/Proprietary Name:
Common/Usual Name:
Submitter 510 (k) Number
TD-3252 Blood Glucose plus Blood Pressure Monitoring System Blood glucose and blood pressure test system TaiDoc Technology Corporation K091555
21 CFR 862.1345 / 21 CFR 870.1130
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4. Device Description
The FORA D40d Blood Glucose plus Blood Pressure Monitoring System FORA Wisdom D40d Blood Glucose plus Blood Pressure Monitoring System consists of one monitor, test strip, control solution, and a pressure cuff. The proposed device has been designed, tested, and demonstrated to work together as a system to produce accurate blood glucose test results and blood pressure measurements.
The proposed device contains speaking function which offers step-by-step audio instructions to help users perform a glucose test or take a blood pressure measurement.
5. Intended Use
FORA D40d for single patient use
The FORA D40d Blood Glucose plus Blood Pressure Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, and upper arm. This system is intended to be used by a single person and should not be shared.
The FORA D40d Blood Glucose plus Blood Pressure Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The FORA D40d Test Strips are for use with the FORA D40d Blood Glucose plus Blood Pressure Monitoring System to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, and upper arm.
This 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 an inflatable cuff wrapped around the arm.
This system contains speaking function, but is not intended for use by the visually impaired.
FORA Wisdom D40d for multiple patients use
The FORA Wisdom D40d Blood Glucose plus Blood Pressure Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary
2
whole blood samples drawn from the fingertips, palm, forearm, and upper arm. This system is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. This system is only used with single-use auto-disabling lancing devices.
The FORA Wisdom D40d Blood Glucose plus Blood Pressure Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing such as the palm, forearm, and upper arm should be done only during steady - state times (when glucose is not changing rapidly).
The FORA Wisdom D40d Test Strips are for use with the FORA Wisdom D40d Blood Glucose plus Blood Pressure Monitoring System to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, and upper arm.
This 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 an inflatable cuff wrapped around the arm.
This system contains speaking function, but is not intended for use by the visually impaired.
6. Comparison to Predicate Device
For blood glucose, consumer study was performed to evaluate the accuracy at fingertip and alternative sites including palm, forearm and upper arm compared to YSI-2300. For blood pressure, a clinical study was performed compared to the reference method according to the requirements of ANSI/AAMI SP10.
The FORA D40d and FORA Wisdom D40d Blood Glucose plus Blood Pressure Monitoring Systems are substantially equivalent to the predicate device, TD-3252 Blood Glucose plus Blood Pressure Monitoring System (K091555).
7. Performance Studies
To evaluate the system accuracy of FORA D40d and FORA Wisdom D40d Blood Glucose plus Blood Pressure Monitoring System, the consumer study was performed according to ISO 15197 and other tests performed according to ANSI/AAMI SP10. Results show that the device met the requirements of ISO 15197 and ANSI/AAMI SP10, and is safe during
3
the use. It is substantially equivalent to the predicate device with the same effectiveness and safety.
The proposed device met the requirements of IEC/EN 60601-1:1995, IEC/EN 60601-1-2:2001, EN 61326-1:2006, IEC/EN 61010-1:2001 and IEC/EN 61010-2-101:2002. It complies with Part 15 of FCC rules. Software validation was also performed to verify and validate the system works functionally.
8. Conclusion
The FORA D40d and FORA Wisdom D40d Blood Glucose plus Blood Pressure Monitoring Systems demonstrate satisfactory performance and are suitable for its intended use. The FORA D40d and FORA Wisdom D40d Blood Glucose plus Blood Pressure Monitoring Systems are substantially equivalent to the predicate device.
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Public Health Service
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its back, representing the department's mission to promote health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle symbol. The logo is presented in black and white.
TAIDOC TECHNOLOGY CORPORATION C/O LINDA KO 3F-5F NO. 127 WUGONG 2ª0 RD. WUGU DISTRICT NEW TAIPEI CITY CHINA (TAIWAN) 24888
ンディ
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
DEC 2 0 2019
Re: K101926
Trade Name: FORA D40d Blood Glucose plus Blood Pressure Monitoring System FORA Wisdom D40d Blood Glucose plus Blood Pressure Monitoring System
Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW. CGA. DXN Dated: December 2, 2011 Received: December 12, 2011
Dear Ms. Ko:
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 mav, 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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Page 2
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/Medical
Devices/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,
$\mathcal{N}$
Countney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices 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: K101926 Device Name: FORA D40d Blood Glucose plus Blood Pressure Monitoring System
Indications for Use:
The FORA D40d Blood Glucose plus Blood Pressure Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, and upper arm. This system is intended to be used by a single person and should not be shared.
The FORA D40d Blood Glucose plus Blood Pressure Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The FORA D40d Test Strips are for use with the FORA D40d Glucose plus Blood Pressure Monitoring System to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, and upper arm.
This 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 an inflatable cuff wrapped around the arm.
This system contains speaking function, but is not intended for use by the visually impaired.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (21 CFR Part 801 Subpart D)
Over the Counter Use ___X (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K101926
Page 1 of 2
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Indications for Use .
510(k) Number: k101926_:
510(K) Number. K101726.
Device Name: FORA Wisdom D40d Blood Glucose plus Blood Pressure Monitoring System
Indications for Use:
The FORA Wisdom D40d Blood Glucose plus Blood Pressure Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, and upper arm. This system is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. This system is only used with single-use auto-disabling lancing devices.
The FORA Wisdom D40d Blood Glucose plus Blood Pressure Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. Alternative site testing such as the palm, forearm, and upper arm should be done only during steady – state times (when glucose is not changing rapidly).
The FORA Wisdom D40d Test Strips are for use with the FORA Wisdom D40d Blood Glucose plus Blood Pressure Monitoring System to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, palm, forearm, and upper arm.
This 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 an inflatable cuff wrapped around the arm.
This system contains speaking function, but is not intended for use by the visually impaired.
Over the Counter Use _________________________________________________________________________________________________________________________________________________________ Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (21 CFR Part 801 Subpart C) (21 CFR Part 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) 1 = 10/926
Page 2 of
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