(154 days)
YSI 2300 Glucose Analyzer
No
The summary describes a standard blood glucose monitoring system and does not mention any AI or ML components.
No
The device is a blood glucose monitoring system, which is used for measurement and monitoring, not for therapy or treatment.
Yes
The device aids in monitoring the effectiveness of diabetes control by quantitatively measuring glucose, which is a diagnostic purpose, even though it explicitly states it is not for "diagnosis of or screening for diabetes". Monitoring blood glucose levels is a key part of managing a diagnosed condition.
No
The device description explicitly states the system consists of a blood glucose meter and test strips, which are hardware components.
Yes, the FORA GD43 Blood Glucose Monitoring System is an IVD (In Vitro Diagnostic) device.
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The FORA GD43 Blood Glucose 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."
- Nature of the Test: The device measures glucose in a biological sample (blood) outside the body to provide information about a person's health status (diabetes control). This is the core definition of an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The FORA GD43 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the fingertip and alternative sites (palm, forearm and upper arm). This blood glucose monitoring system is intended to be used by a single person and should not be shared. Alternative site testing (AST) should only be done during steady-state times (when glucose is not changing rapidly).
The FORA GD43 Blood Glucose 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 use on neonates.
The FORA GD43 Test Strips are for use with the FORA GD43 Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary whole blood from the fingertip and alternative sites (palm, forearm and upper arm).
Product codes
NBW, LFR
Device Description
The system consists of blood glucose meter and test strips. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. Use only FORA GD43 test strips with the FORA GD43 Blood Glucose Monitoring System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip and alternative sites (palm, forearm and upper arm)
Indicated Patient Age Range
This system should not be used for the diagnosis of or screening for diabetes, nor for use on neonates.
Intended User / Care Setting
self-testing outside the body (in vitro diagnostic use) by people with diabetes 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
Clinical and non-clinical studies were conducted to tested, verified and validated with respect to the predicate device to establish the performance of the FORA GD43 Blood Glucose Monitoring System.
Key Metrics
More than 95% of the individual glucose results fall within 15 mg/dL at glucose concentrations
§ 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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May 7, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
TAIDOC TECHNOLOGY CORPORATION PAUL LIU REGULATORY AFFAIRS SPECIALIST B1-7F, NO.127, WUGONG 2ND RD., WUGU DISTRICT NEW TAIPEI CITY 24888 TAIWAN
Re: K143467
Trade/Device Name: FORA GD43 Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW. LFR Dated: March 31, 2015 Received: April 2, 2015
Dear Mr. Paul Liu:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Katherine Serrano -S
For : Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K143467
Device Name
FORA GD43 Blood Glucose Monitoring System
Indications for Use (Describe)
The FORA GD43 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the fingertip and alternative sites (palm, forearm and upper arm). This blood glucose monitoring system is intended to be used by a single person and should not be shared. Alternative site testing (AST) should only be done during steady-state times (when glucose is not changing rapidly).
The FORA GD43 Blood Glucose 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 use on neonates.
The FORA GD43 Test Strips are for use with the FORA GD43 Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary whole blood from the fingertip and alternative sites (palm, forearm and upper arm).
Type of Use (Select one or both, as applicable)
_ Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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: K143467
1. Submitter Information
| Company Name: | TaiDoc Technology Corporation |
|---|---|
| Contact Person: | Paul Liu |
| Title: | Regulatory Affairs Specialist |
| Address: | B1-7F, No. 127, Wugong 2nd Rd., Wugu District, New Taipei City, |
| 24888, Taiwan | |
| Phone: | +886-2-6625-8188 |
| Fax: | +886-2-6625-0288 |
| E-mail: | paul@taidoc.com.tw |
| Prepared Date: | May 4th, 2015 |
2. Device name:
| Proprietary Name: | FORA GD43 Blood Glucose Monitoring System |
|---|---|
| Common Name: | Blood Glucose Monitoring System |
| Product Code: | NBW, Blood Glucose Test System, Over-the-Counter |
| LFR, Glucose Dehydrogenase | |
| Classification Panel: | Clinical chemistry |
| Classification: | Class II |
| Regulation Citation: | 21 CFR §862.1345, Glucose test system |
3. Predicate Device
| Proprietary Name: | FORA GD40 Blood Glucose Monitoring System |
|---|---|
| Common Name: | Blood Glucose Monitoring System |
| 510(k) Number: | K101509 |
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Image /page/4/Picture/0 description: The image shows the logo for TaiDoc. The logo consists of the word "TaiDoc" in gray, with three red hearts below it. Below the hearts is the website address "www.taidoc.com" in white text on a gray background.
4. Intended Use
The FORA GD43 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the fingertip and alternative sites (palm, forearm and upper arm). This blood glucose monitoring system is intended to be used by a single person and should not be shared. Alternative site testing (AST) should only be done during steady-state times (when glucose is not changing rapidly).
The FORA GD43 Blood Glucose 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 use on neonates.
The FORA GD43 Test Strips are for use with the FORA GD43 Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary whole blood from the fingertip and alternative sites (palm, forearm and upper arm).
5. Device Description:
The system consists of blood glucose meter and test strips. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. Use only FORA GD43 test strips with the FORA GD43 Blood Glucose Monitoring System.
6. Comparison to the Predicate:
The modified FORA GD43 Blood Glucose Monitoring System has the following similarities to the predicate device:
- . Same operating principle.
- . Same functions and physical appearance.
- Same fundamental scientific technology.
- Same user interface. ●
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Image /page/5/Picture/0 description: The image shows the logo for TaiDoc. The logo consists of the word "TaiDoc" in a bold, sans-serif font, with three red hearts below it. Below the hearts is the website address "www.taidoc.com" in a smaller, sans-serif font, set against a gray background. The overall design is simple and clean, with a focus on the company name and website.
The modifications:
- The material of test strip electrode is changed
- . The sample volume required is changed
-
- Test Principle:
The blood glucose is based on the measurement of electrical current generated by the reaction of glucose with the reagent of the strip. The meter utilizes the current signal to calculate the blood glucose level.
-
- Performance Characteristics:
Clinical and non-clinical studies were conducted to tested, verified and validated with respect to the predicate device to establish the performance of the FORA GD43 Blood Glucose Monitoring System. More than 95% of the individual glucose results fall within 15 mg/dL at glucose concentrations
- Performance Characteristics: